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Support/Education

Ovarian and Breast Cancer Screening and Prevention

Cancer Screening and Prevention Program for High Risk Women (NCT00849199)

Summary

Women who are at high-risk for developing breast and ovarian cancer require cancer screening and education programs that address their unique needs and concerns. The NYU Cancer Institute at New York University Medical Center is designing a new program for high-risk women. The purpose of this study is to determine whether the program's questionnaire directs high-risk women to the appropriate educational materials and ensures they obtain the proper tests and speak with the right specialists. To be eligible for this study, individuals must have a personal or family history of breast or ovarian cancer or have a perceived increased risk of breast or ovarian cancer.

Effect of Diet & Exercise Before Surgery In Overweight Postmenopausal Women with DCIS

Exploring Effects of Weight Loss on Ductal Carcinoma In Situ (NCT02224807)

Summary

Ductal carcinoma in situ (DCIS) is a stage 0, pre-cancer. Women with DCIS are at increased risk for developing breast cancer. Because it is not yet known which DCIS will progress on to breast cancer and which will not, currently most women are treated for DCIS with surgery and often radiation or hormone therapy. Post-menopausal women who are overweight are at increased risk for invasive breast cancer. Animal studies suggest that very low calorie diets may slow cancer growth. Calorie restriction in women with DCIS may reduce their risk of developing invasive breast cancer. This study is looking at the effect that diet and exercise have on biomarkers found in breast tissue and blood that provide information about cancer progression, hormonal status, inflammation, tumor proliferation and cell death. To be eligible, a woman must be overweight or obese (BMI: 25-39.9), postmenopausal and scheduled to have a lumpectomy or mastectomy for DCIS in three weeks or more.

Prevention Education For African American Women

Disseminating Breast Cancer Prevention to African American Women (NCT01299623)

Summary

African American women are more likely to have breast cancer that is more aggressive, and diagnosed at an earlier age compared to other ethnic and racial groups. Older African-American women are less likely to be diagnosed with breast cancer, but they are more likely to be diagnosed with an aggressive, later stage tumor. Researchers are trying to develop effective breast cancer education programs for African-American women. This study will evaluate a breast cancer prevention education program that is culturally tailored to African-American women. To be eligible, participants must be a resident of the Philadelphia metropolitan area.

Work-Related Cognitive Problems Experienced by Breast Cancer Survivors

The Relationship Between Biopsychosocial Functioning and Work-Related Cognitive Limitation Among Employed Breast Cancer Survivors: Case Control Study. (NCT02303145)

Summary

Cognitive functioning includes a person's ability to remember, process thoughts, pay attention, solve problems and concentrate. Cancer therapies can cause cognitive functioning problems that can impact breast cancer survivors' general well-being. Lumosity is an online tool that allows anyone to increase their "brain fitness." This study is looking at the relationship between the cognitive problems breast cancer survivors experience at work, the breast cancer treatments they have had, and other emotional or psychological problems, such as depression, anxiety, pain, fatigue, and sleep disturbances, they may be experiencing. In this study, psychological and physical well-being will be self-reported through web-based questionnaires and cognitive functioning will be measured using the Lumosity Brain Performance Test (BPT). To be eligible, breast cancer patients must have completed treatment (hormone therapy is ok), be working part- or full-time, and have internet access. This trial is also enrolling healthy women who have not had breast cancer to be part of a comparison group.

  • Participation TimeOnline questionnaire
  • No Visits Required for this TrialNo travel required 

Behavioral Weight Loss and Exercise After Treatment (BEAT) for Early-Stage Breast Cancer

Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors (NCT02052115)

Summary

Studies have found that breast cancer survivors who are overweight and not physically active are at increased risk for a breast cancer recurrence. Side effects of cancer and its treatment, such as fatigue, distress and memory loss, may have an effect on a woman's ability to maintain a healthy diet, lose weight, or exercise. Researchers have developed a behavioral weight loss and exercise after treatment (BEAT) program for breast cancer survivors. This study is looking at the effectiveness of the BEAT program and whether side effects like fatigue, distress, and cognitive functioning impact the program's effectiveness.

Information About Mammography Screening for Women Age 75 and Older

Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older (NCT02198690)

Summary

It is not known whether the benefits of mammography screening outweigh the risks in women age 75 and older. To improve older women's understanding of the benefits and risks of mammography screening, researchers have developed a pamphlet that provides information about mammography specifically for this age group. This study is investigating whether the pamphlet improves older women's decision-making about mammography screening. To be eligible, women must be between the ages of 75 and 89.

Cognitive-Behavioral Therapy for Insomnia After Treatment

Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment (NCT00672217)

Summary

Many cancer patients experience persistent difficulty falling asleep or staying asleep. Studies have shown that psychological and behavioral factors play an important role in insomnia. Cognitive behavioral therapy (CBT) is an effective treatment for insomnia that provides an alternative to sleeping pills. The CBT approach aims to change the thoughts and actions that interfere with the ability to get restful sleep. The goal of this study is to examine the effects of CBT on women who experience long-term difficulty with sleeping after cancer treatment. Participants must have completed radiation or chemotherapy within three years of beginning this study.

Healthy Living After Cancer: A Weight Management Pilot Study

Healthy Living After Cancer: Weight Management Pilot Study (NCT01978899)

Summary

Studies suggest that women and men who are overweight at the time of their cancer diagnosis are at increased risk of developing surgical complications, fatigue, a poor body image or other problems. Cancer patients who lose weight after their cancer diagnosis may experience fewer of these problems. Losing weight may also decrease a patient's risk of recurrence. Researchers want to determine which weight-loss program is best for cancer survivors. This study is evaluating the effectiveness of a 16-week diet and exercise program in women and men who have been diagnosed with cancer. (This study is enrolling patients with breast and other types of cancers.)

Providing Lymphedema Education to Breast Cancer Patients Prior to Surgery

Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema (NCT02073045)

Summary

Women and men who have breast cancer surgery are at risk of developing lymphedema—a painful swelling of the arm and hand. Educating patients about risk factors for and symptoms of lymphedema may improve their ability to identify, and reduce, these symptoms after surgery. This study is looking at the impact a lymphedema education program provided before surgery has on breast cancer patients. To be eligible, a patient must be scheduled for surgery at University Hospitals Seidman Cancer Center in Cleveland, Ohio.

Comparing Therapies for Depression Related to Breast Cancer

Interpersonal Therapy for Depression in Breast Cancer (NCT01191580)

Summary

Depression can negatively affect a cancer patient's adherence to treatment, survival, symptom management, psychosocial functioning, and quality of life. The goal of this trial is to compare the effectiveness of three different types of therapy (Interpersonal Psychotherapy, Problem-Solving Therapy, and Brief Supportive Psychotherapy) in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer who have been diagnosed with Major Depressive Disorder.
This is a Phase IV trial

Nueva Vida Program for Latina Breast Cancer Survivors and Their Caregivers

Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers (NCT02222337)

Summary

Studies have found that Latina breast cancer survivors tend to have a lower quality of life than other breast cancer survivors. The problems Latina breast cancer survivors experience can affect their immediate family and friends. The goal of this study is to test and refine a skills building program called Nueva Vida that was created specifically for Latina survivors and their caregivers. To be eligible for this study, Latina breast cancer survivors and their caregivers must speak English or Spanish.

Counseling for Breast Cancer Patients Age 70 and Over

Pilot of a Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer (NCT00984321)

Summary

Many women seek counseling after a breast cancer diagnosis. This counseling program was developed to meet the specific needs of older cancer patients, who often find themselves facing problems related to both cancer and aging. The goal of this trial is to see whether a counseling program can help reduce depression, anxiety, and feelings of loneliness and isolation as well as improve the quality of life of older women with breast cancer. To be eligible, participants must be receiving treatment at Memorial Sloan-Kettering Cancer Center.

Survivorship Care Planning to Improve Quality of Life

Survivorship Care Planning for At Risk Breast Cancer Survivors: A Focus on Latina-, Asian-, African-, and European Americans (NCT01824745)

Summary

Survivorship care planning may reduce stress and improve the well-being and quality of life of breast cancer survivors. The best method for providing survivorship care planning services is not yet known. This study is comparing the effectiveness of providing breast cancer survivors with a Survivorship Care Planning booklet along with four 40-minute counseling sessions to providing breast cancer survivors with a Survivorship Care Planning booklet alone. Women must live in Southern California and be 6-18 months post diagnosis--and at or nearing the end of their cancer treatment--to be eligible for this study.

Comparing Two Types of Support Groups for Women with Metastatic Breast Cancer

Self-management Interventions for Pain in Advanced Breast Cancer (NCT01927081)

Summary

Studies have found that breast cancer patients often benefit from talking about their illness with other breast cancer patients. Support groups can foster these types of discussions. This study is comparing two different types of support groups for women with metastatic breast cancer. To be eligible, a woman must be receiving breast cancer care at the Duke Cancer Institute in Durham, North Carolina.

Exercise & Weight Management for People at High Risk for Triple-Negative Breast Cancer

Pilot Tests to Optimize the Delivery of Energy Balance Interventions (NCT02194387)

Summary

Previous studies have suggested that risk for triple-negative breast cancer (TNBC) is higher in people who are overweight and not physically active. Researchers are trying to determine what types of programs can help people lose weight and exercise more. Fitbit® is a small, wearable physical activity tracker that is designed to help with exercise and weight management. Telephone coaching, text messages, social networking, and self-monitoring can also help people trying to exercise more and lose weight. This study is looking at which combination of coaching, texting, and social networking is most effective in helping women at high-risk for breast cancer exercise more and lose weight. To be eligible, participants must have a BMI ≥25. They must also know they carry a BRCA mutation or be a family member of a breast cancer survivor.

Breast Health Coaches for Older African-American Women

Evaluating Coaches for Older Adults Cancer Care and Health (NCT01613430)

Summary

Studies have shown that African-American women are less likely than white women to get regular mammograms, which increases their chances of being diagnosed with a later stage breast cancer. A coach is an individual whom the participant trusts to navigate her through the health care system. Researchers believe that for older women, a coach who is a member of her extended family may be more effective than a coach who she has not met before. The overall goal of this study is to compare the effectiveness of trained health coaches with traditional health education efforts to increase breast cancer screening in older African-American women. To be eligible, participants must be African American, residents of Baltimore City or Prince George's County, Maryland, 65 to 74 years of age, and enrolled in Medicare Parts A and B.

Genetic Testing Decisions In Newly Diagnosed Ashkenazi Women

Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer (NCT01386411)

Summary

Women who are diagnosed with breast cancer at a young age and/or who are of Ashkenazi Jewish descent are more likely to carry the BRCA1 or BRCA2 genetic mutation that increases risk for breast and ovarian cancer. Genetic testing for the BRCA1/2 mutation can help women make decisions about their breast cancer treatment. The purpose of this trial is to see whether women prefer having genetic testing before or after their breast cancer surgery. The study will also look at how women feel about their decision at a later date. To be eligible for this trial, participants must be 18 – 50 years old at diagnosis, be of Ashkenazi Jewish descent, and be planning to undergo breast surgery as part of their treatment.

Helping Mothers Talk to Their Children About BRCA1/2 Testing

Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children (NCT00685256)

Summary

Mothers who undergo BRCA testing often have questions about how and when to discuss genetic testing with their children. Researchers have developed a decision-making guide to help improve mother-child communication about BRCA testing. This study is investigating whether using this decision-making guide along with genetic counseling is better than genetic counseling alone in addressing the needs of mothers undergoing BRCA1/2 testing and their minor-age children.
This is a Phase III trial

Web-Based Support for Patients Managing Lymphedema

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors (NCT01779063)

Summary

Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, breast cancer treatments can cause lymphedema, a painful swelling of the arm and hand. Lymphedema is a lifelong condition that requires daily self-care, which can be physically and emotionally challenging. Researchers are trying to develop new ways to help breast cancer patients manage their lymphedema. One new program that may be effective includes a Web-based, multimedia intervention and a "take home" manual that supports self-care. This study is comparing this new Web-based program to an educational booklet now in use to see which does a better job of improving breast cancer survivor's self-care behaviors, addressing their physical and emotional concerns and reducing the money they spend on lymphedema treatment.

Peer Education Program for African-American Survivors

Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer (NCT01450020)

Summary

Breast cancer survivors often face a variety of physical, emotional and logistical challenges after treatment ends. A breast cancer peer navigator is a breast cancer survivor who has been trained to provide information on breast cancer-related issues and resources. Researchers believe that obtaining information from a fellow breast cancer survivor may help to improve the well-being and quality of life of women who have recently completed breast cancer treatment. The goal of this study is to determine whether assistance from a peer navigator will help to improve the understanding of survivorship planning and to increase the likelihood that individuals will attend their follow-up appointments. To be eligible, individuals must self-identify as African American and have completed treatment within the last 12 months for stage 0-3 breast cancer.

Increasing Mammography Screening Rates Among Korean-American Women in Minnesota

Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase (NCT01972048)

Summary

Korean-American women have one of the lowest breast cancer screening rates of U.S. American women. mMammogram is a mobile app that uses messages, video, audio, and emoticons to educate, promote, and reinforce breast cancer screening. This study is comparing the effectiveness of mMammogram to an educational brochure for increasing mammography screening rates among Korean-American women between the ages of 40 and 70. To be eligible, a woman must be Korean-American, have a phone that can receive text messages, and be living in Minnesota.

A Program to Help Metastatic Breast Cancer Patients Participate in Treatment Decisions

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer (NCT01811264)

Summary

Women who are actively involved in their health care tend to feel better about the treatment they are receiving. Researchers have developed a brief Patient Participation Aid that uses text and images to teach patients how to ask questions and assert personal preferences. This study is investigating whether the Aid improves the well-being of women with metastatic breast cancer by empowering them to be active participants during doctor's appointments. To be eligible, participants must have metastatic breast cancer and be receiving care at one of the participating study clinics.

MDMA-Assisted Therapy for Anxiety Related to Metastatic Cancer

Phase II Dose-Response Pilot Study of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Anxiety Associated With Advanced-Stage Cancer (NCT00252174)

Summary

A diagnosis of advanced stage cancer can cause intense anxiety. MDMA (3,4-methylenedioxymethamphetamine) may be able to help relieve this anxiety by producing feelings of closeness to others, empathy, wellbeing, and insightfulness. MDMA has been previously shown by some psychotherapists to reduce anxiety and improve quality of life in terminally ill patients. Currently, it cannot be used outside of research studies. This study will examine the effects of MDMA-assisted psychotherapy in patients who have received a diagnosis of advanced stage cancer. Participants must have completed or decided to end all cancer treatments prior to beginning this study.
This is a Phase II trial

Health Education for Reducing Chemotherapy-Related Weight Gain

Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy (NCT01941784)

Summary

Weight gain is a common side effect of chemotherapy treatment. The average patient gains about 5-8 pounds over a year. THRIVE (Taking Health Realization Into Valued Eating and Exercise) is a health education program that may help reduce weight gain and improve the quality of life of women undergoing chemotherapy. The goal of this study is to determine the effectiveness of the THRIVE project for preventing weight gain associated with chemotherapy treatments in women with newly diagnosed stage I-IV breast cancer who have recently started or are schedule to receive chemotherapy.

Multi-Media Support Program for Post-Treatment Survivors

Multi-Media Imagery Program for Breast Cancer Patients (Phase II) (NCT01034215)

Summary

Many women who have been treated for early stage breast cancer experience long-term effects, such as chemobrain, fatigue, sleep deprivation, stress, anxiety, depression, and post-traumatic stress disorder (PTSD). The goal of this study is to evaluate the effectiveness of a multi-media program, called "Envision the Rhythms of Life," that aims to reduce stress and improve quality of life. The program uses animation, PowerPoint, manuals, art, and audio-art. To be eligible, it must be at least six weeks since the completion of surgery, radiation, and/or IV-delivered chemotherapy.
This is a Phase II trial

Vitamin D to Treat Anti-Estrogen Therapy Side Effects in Women with Stage IV Breast Cancer

Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) (NCT02186015)

Summary

Anti-estrogen therapies are used to treat ER+ and/or PR+ breast cancer. Side effects of these therapies include pain, fatigue, mood and sleep disturbances. Researchers think that vitamin D supplements may help reduce these side effects. However, vitamin D can also lead to excess calcium in the blood, which could increase estrogen production in the body. This study will monitor blood calcium and vitamin D levels to identify the best dose and effectiveness of a vitamin D supplement for reducing anti-estrogen related side effects in women with metastatic breast cancer.
This is a Phase I trial

Evaluating A Weight-Loss Program for Overweight Breast Cancer Survivors

Lifestyle, Exercise and Nutrition (LEAN) Study 2 (NCT02110641)

Summary

Studies have found that women who are overweight when diagnosed with breast cancer are at increased risk of having a breast cancer recurrence. This is believed to be, in part, because fat tissue raises estrogen levels. In addition, women who are overweight often have high insulin levels—which studies suggest increases cancer risk. Researchers are trying to determine which diet and exercise programs can help overweight breast cancer survivors lose weight. This study is evaluating the efficacy and cost-effectiveness of a 6-month weight-loss program. To be eligible, participants must have completed primary treatment for breast cancer at least two months prior to starting the study and have a BMI (body mass index) > 25.
This is a Phase III trial

Lifestyle Changes During Radiation Therapy to Improve Outcomes

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes (NCT02079662)

Summary

Researchers are studying the effects that lifestyle has on the risk of a breast cancer recurrence, quality of life, physical functioning, hormone levels and immune function. This study is looking at the effect that a comprehensive lifestyle change program that addresses diet, exercise, and stress has on women with stage III breast cancer who are scheduled to have a 4 to 6-week course of radiation. To be eligible patients must have a body mass index (BMI) of 25 or higher. They must also not eat more than 3 servings of fruits/vegetables a day or exercise more than 75 minutes per week.

A Computer-Based Intervention to Help Manage Fear of Recurrence

Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study (NCT01517945)

Summary

It is not uncommon for women and men who have been treated for breast cancer to have a difficult time getting past the fear that they will have a cancer recurrence. The goal of this study is to develop and test a computer-based intervention program that was specifically developed to help early-stage breast cancer survivors cope with the fear of recurrence. To be eligible, participants must have finished cancer treatment (current hormone therapy is allowed) more than 1 year but less than 5 years ago.

Helping Patients Learn to Cope with Symptoms and Side Effects of Cancer and its Treatments

Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial (NCT02288169)

Summary

Cancer and its treatments can result in symptoms and side effects that lead to depression, anxiety and a diminished quality of life. Helping patients learn how to manage difficult symptoms on their own may diminish suffering, improve quality of life and decrease emergency room visits and associated costs. COPE (Creativity, Optimism, Planning, Expert guidance) is a program initially developed by researchers at the University of South Florida to help cancer caregivers. This study is looking at whether the COPE program works well for cancer patients too. This study is enrolling patients with breast, colorectal, lung or prostate cancer patients who are experiencing distress.

A Program to Increase Cancer Screening, Reduce Depression in Women in the Bronx

Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project (NCT02273206)

Summary

Researchers are trying to increase cancer screening rates among low-income minority women in the Bronx County, New York. Women who are depressed may not get necessary cancer screening tests. Within New York City, the highest rates of depression are found in the Bronx. In this study, researchers are comparing two types of collaborative care programs that have been developed to reduce depression and improve cancer screening and cancer outcomes among low-income minority women from the Bronx. To be eligible, women must be between the ages of 50 and 64, a resident of the Bronx, screen positive for depression, overdue on breast cancer and other cancer screening tests, and not have been diagnosed with cancer within the past six months.

Nutrition Education and Acupuncture for Weight Loss After Chemotherapy

Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone (NCT02081612)

Summary

Studies have found that women with breast cancer who are overweight or who gain weight after their diagnosis are at increased risk of having a cancer recurrence. Acupuncture uses hair-thin needles to stimulate energy in the body. Acupuncture may help improve short and long-term weight loss among breast cancer survivors who have been treated with chemotherapy. This study is investigating whether using acupuncture along with a nutrition education program is better than using a nutrition education program alone in helping breast cancer survivors lose weight. To be eligible, participants must have completed breast cancer treatment and have a body mass index (BMI) of 30 or greater.

Effect of a Patient Navigation Program Developed for Latina/Hispanic Cancer Survivors

Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program (NCT02275754)

Summary

Studies have found that Latinas/Hispanics generally have lower rates of cancer survival than women of other ethnic or racial groups. They also tend to have more health disparities and less access to care, which can affect their lives as cancer survivors. The LIVESTRONG Cancer Navigation Services Patient Navigator program offers peer navigators to help cancer patients following their cancer care. This study is comparing two ways of providing a patient navigation program that has been developed specifically for Latina/Hispanic survivors. It is also looking at whether the program improves cancer survivors' quality of life, cancer care and treatment follow-up. To be eligible, a woman must have been diagnosed with breast cancer within the past 15 months, have no evidence of metastatic disease and not be undergoing cancer treatment. This study also is enrolling patients who have completed treatment for prostate or colorectal cancer.

Mindfulness Based Theapy for Women with Breast Cancer & Their Partners

Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study (NCT02349217)

Summary

Mindfulness-based cognitive therapy is a psychological therapy designed to help people who are prone to recurring depression. It combines meditation, breathing exercises and stretching with cognitive therapy to help break negative thought patterns. This study is looking at the feasibility of conducting and the effect that a Mindfulness Based Cognitive Intervention has on relationship satisfaction, quality of life and immune system function in breast cancer survivors and their partners. To be eligible, couples must have lived together for at least 3 years.

Providing Support to Newly Diagnosed Patients

A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life (NCT01742143)

Summary

Breast cancer treatment is most effective when a patient is able to follow her treatment plan. The Integrated Cancer Care Access Network (ICCAN) program provides individualized assistance to women being treated at New York City hospitals who are low-income or have other problems that may make it difficult for them to stay on their treatment. Women who take part in the program meet monthly with a facilitator to get assistance and support. This study is comparing the ICCAN program to the standard services provided in New York City hospitals, which include meeting with a social worker or a patient navigator. To take part, patients must speak English, Spanish, or Mandarin, have been diagnosed with breast cancer within the past month, and be currently receiving or scheduled to start chemotherapy or radiation.

Mind-Body Program for Metastatic Cancer Patients

Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients (NCT00179387)

Summary

Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, and relationship strains are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in relieving distress and improving quality of life among cancer patients. The purpose of this study is to find out if mind-body psychotherapy groups can help improve the physical and emotional well-being of people facing cancer. Participants must be on active cancer treatment.

Brief Behavioral Therapy to Improve Chemotherapy-Related Sleep Problems

Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial (NCT02002533)

Summary

Sleep problems are a common side effect of chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia and improve quality of life in cancer patients. Brief Behavioral Therapy (BBT) is a technique that consists of insomnia education, stimulus control, discouragement of napping and encouragement of exercise and sleep. Researchers are interested in seeing if BBT is an effective way to improve chemo-related sleep problems. This study is investigating whether BBT is more effective than the Healthy Eating Education (HEAL) program in improving sleep problems in patients with stage I-III breast cancer undergoing chemotherapy. To be eligible, participants must have sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy.
This is a Phase II trial

Omega-3 Fatty Acids (Fish Oil) to Reduce Fatigue in Breast Cancer Survivors

Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue (NCT02352779)

Summary

Omega-3 fatty acids (fish oil) are nutrients that are essential for good health that are obtained through food or supplements. Scientists think that omega-3 fatty acids may help reduce cancer-related fatigue in breast cancer survivors. This study is comparing the safety and effectiveness of two different doses of an omega-3 fatty acid supplement to a placebo for reducing cancer-related fatigue in breast cancer survivors. To be eligible, patients must have completed standard adjuvant treatment (surgery, chemotherapy, radiation) and be experiencing cancer-related fatigue.
This is a Phase II trial

Using Patient Navigators to Address Racial Disparities in Cancer

Accountability for Cancer Care Through Undoing Racism and Equity (NCT01954641)

Summary

Statistics show that although a larger percentage of white Americans are diagnosed with breast and lung cancer, a larger proportion of African-Americans die from these diseases. Researchers are trying to find ways to reduce this disparity. Studies suggest that patient navigators who have comprehensive training in cancer issues, health literacy and communication techniques can benefit patients. The Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) trial is comparing patients who work with patient navigators and patients who receive usual support and care. This study is enrolling white and African-American women and men who are being treated for stage I or II breast (or lung) cancer.

Reducing Pain, Fatigue & Sleep Disturbances in Patients with Advanced Cancer

A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer (NCT01954420)

Summary

Pain, fatigue, and sleep disturbances are common side effects and symptoms of advanced cancer that can have a negative effect on quality of life. Cognitive-behavioral strategies, like relaxation, distraction, and imagery, can help reduce these symptoms. Listening to guided imagery, relaxation exercises, and nature sound recordings on an MP3 player (an iPhone or similar device) is one method of using cognitive-behavioral therapy. This study is testing whether a patient-controlled cognitive-behavioral program available on an MP3 player can reduce pain, fatigue, sleep disturbances, and stress during cancer treatment. To be eligible, the patient must be receiving outpatient chemotherapy in 3-week cycles, with ≥ 1 drug administered intravenously, and be expected to receive at least 3 more cycles of chemotherapy after enrollment. This study is also recruiting patients with advanced lung, colorectal, prostate or gynecologic cancers.

An Educational Tool for Women Considering Breast Reconstruction

Decisional Aid Intervention for Women Considering Breast Reconstruction (NCT01951534)

Summary

Many women find that it is not easy to decide whether to have breast reconstruction. Researchers have developed a web-based Breast Reconstruction Decisional Aid (BRDA) they hope will help women make this decision. This study is comparing the BRDA to an educational pamphlet and routine care. The researchers will see if women find the BRDA useful and how it influences their decision-making. The researchers will also look at what effect the BRDA has on women's breast reconstruction knowledge, attitudes about breast reconstruction, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with their oncologist.

A Study Comparing Online and In-Person Pain Management Programs for Cancer Patients

An Accessible Mobile Health Behavioral Intervention For Cancer Pain (NCT02266017)

Summary

Many cancer patients experience pain from the cancer or its treatments. Studies have found that these patients can benefit from programs that increase their confidence in their ability to manage their pain. It is difficult for patients who do not live near a medical center to participate in a pain management program. Mobile health (mHealth) technologies that use a tablet computer or videoconferencing may be beneficial for these patients. This study is comparing the effectiveness of an mHealth program and a traditional in-person pain management program in patients who were diagnosed with breast cancer within the last year. This study also is enrolling patients with lung, prostate or colorectal cancer.

Exercise and Counseling to Prevent Lymphedema

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection (NCT00376597)

Summary

A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection. This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Metformin & Healthy Lifestyle Study for Overweight Survivors

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors (NCT01302379)

Summary

Studies suggest that women who are overweight are at higher risk of experiencing a breast cancer recurrence. Adopting a healthy lifestyle that includes good nutrition and exercise may help with weight management. Metformin (Glucophage®) is an oral medication commonly used by people with diabetes to control insulin levels. Laboratory and epidemiological studies suggest that metformin may also have anticancer effects. This study will test the effect of metformin and healthy lifestyle education, alone or in combination, on biomarkers (proteins or molecules found in blood or tissue) that are linked to the risk of recurrence. To be eligible, participants must have a body mass index (BMI) of at least 25, and must not currently be taking insulin or any other antidiabetic drug.

Weight Loss Program To Prevent Recurrence in Overweight Women With Early Stage Disease

A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer (NCT01871116)

Summary

Research suggests that excess body weight may be a major risk factor for breast cancer. Weight loss is helpful for improving overall health, but may also decrease the chance of breast cancer coming back. The goal of this study is to see if women who have received treatment for Stage I-III breast cancer will lose weight on a dietary weight-loss program called Practice-based Opportunities for Weight Reduction (POWER). This program uses established behavioral techniques to achieve weight loss and involves online, telephone and email support. To be eligible, participants must have completed surgery and/or radiation therapy but may still be on anti-HER2 or hormone therapy.
This is a Phase II trial

Comparing Two Strategies for Quitting Smoking After a Cancer Diagnosis

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial (NCT01871506)

Summary

Between 10 and 30 percent of people diagnosed with cancer are current smokers. Studies have found that people who continue smoking after a cancer diagnosis have shorter survival times, are more likely to have treatment-related complications, and are at increased risk of developing a second cancer. Currently, only about half of all cancer patients report having been asked about their tobacco use. This study is comparing two strategies to promote smoking cessation in people who are newly diagnosed with, or likely to have, cancer. To be eligible, participants must have smoked a cigarette, even a puff, in the past week and be willing to consider trying to quit smoking using counseling and/or smoking cessation medication. This study is enrolling women and men diagnosed or suspected of having breast or other types of cancers, receiving care at Massachusetts General Hospital Cancer Center or Memorial Sloan Kettering Cancer Center.
This is a Phase IV trial

A Program to Reduce Insomnia (Trouble Sleeping) Caused by Cancer or its Treatment

Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT02165839)

Summary

Many women report that they experience insomnia--trouble sleeping--during their breast cancer treatment. A behavioral therapy program may help breast cancer patients cope with their insomnia. This study will compare a behavioral therapy program for insomnia to a healthy eating program in women being treated with chemotherapy or a biological therapy, like Herceptin, for early-stage breast cancer. To be eligible, a woman must have insomnia that began or got worse when she was diagnosed with cancer or began systemic treatment with chemotherapy or biological therapy.
This is a Phase III trial

Comparing Two Types of Breast Cancer Survivor Support Groups

Development of Group Interventions for Breast Cancer Survivors (NCT01775085)

Summary

Many breast cancer survivors have found that support groups are helpful both during and after treatment. This study will compare the experiences of breast cancer survivors in two different types of support groups. The first is a standard support group that will focus on topics such as social and emotional support, financial issues, return to work, dealing with symptoms, and discussing difficult topics. The second is a meaning-centered group that will focus on topics such as identity, cancer survivorship, and connecting with life via love, beauty, and humor. The study is also testing the benefits and feasibility of conducting the groups online using a telephone and computer. To be eligible, women must have completed their primary treatment for breast cancer between 3 months and 5 years before entering the study.

Preventing Sexual Dysfunction With Aromatase Inhibitors

Preventing Sexual Dysfunction in Women on Aromatase Inhibitors (NCT01603303)

Summary

Aromatase inhibitors (AIs) are used to treat hormone-sensitive breast cancer in post-menopausal women. A common side effect of the AIs is vaginal dryness and pain during sexual activity. Two new vaginal moisturizers are now available. The researchers are interested in seeing if one or both of these moisturizers can reduce dryness and pain during sexual activity in women being treated with an AI. The researchers also want to see if preventing these side effects will get more women to keep taking their AI. (Studies have shown that many women stop taking their AIs because of the side effects.) This study is done by mail, phone and/or internet, and no visits are required.
This is a Phase II trial

Helping Parents Talk to Their School-Age Children About Cancer

Enhancing Connections Telephone Program: A Cancer Education Program for Parents (NCT02129049)

Summary

A cancer diagnosis can cause emotional distress in both parents and children. But it can be difficult for parents to talk to their children about their cancer or support their children while undergoing cancer treatment. Studies have found that the Enhancing Connections Program, an in-person educational program, can decrease parents' depression and anxiety; improve parenting quality, parenting skills and confidence; and enhance the child's behavioral-emotional adjustment. Providing this education program by telephone may help parents talk with their school-age children about their cancer. This trial is investigating the effectiveness of using the Enhancing Connections Program by telephone to improve communication between patients with early stage cancer and their children. To be eligible, participants must have had a diagnosis of stage 0-III breast cancer within the last seven months.

Spousal Relationships and Pain in Metastatic Breast Cancer

Spousal Relationships and Pain in Metastatic Breast Cancer (NCT00386620)

Summary

Researchers are interested in learning more about the needs and preferences of metastatic breast cancer patients and their partners. The goal of this psychosocial research study is to look at factors that may affect the pain experience of patients with metastatic breast cancer. The study is also investigating whether women with metastatic breast cancer and their spouses can use a hand-held computer program designed to assess patient pain, spouse response to patient pain, and patient behavior in response to pain. Women experiencing pain related to their metastatic breast cancer diagnosis are eligible. The woman's male spouse or significant other will be asked to participate.