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1

Values Assessment Tool Questionnaire to Enhance Decision-Making and Communication for Women with Metastatic Breast Cancer

Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)

Purpose: To study whether the Value Assessment Tool questionnaire helps with decision-making and communication.

Who is this for?: Women with stage IV (metastatic) breast cancer who receive their care at North Carolina Cancer Hospital or associated clinics. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Values Assessment Tool</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Incorporating patient values into shared decision-making about treatment options is important. This is especially true for <span class="highlight">Black/African</span> American, Latinx/Hispanic, or American Indian/Alaskan Native people, as these groups have a higher risk of poor communication, worse health outcomes, and increased likelihood of metastatic cancer diagnoses compared to non-Hispanic White adults.</li> <li class="seamTextUnorderedListItem">The Values Assessment Tool is a questionnaire that was designed to help with decision-making and communication.</li> <li class="seamTextUnorderedListItem">Participants will use the Tool at every clinic visit for 3 months.</li> <li class="seamTextUnorderedListItem">This study aims to enroll at least 40% of participants who are <span class="highlight">Black/African</span> American women.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07068477' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/shared-decision-making/' target='_blank'>Metastatic Trial Talk: Shared Decision-Making</a> </li></ul>
1

Values Assessment Tool Questionnaire to Enhance Decision-Making and Communication for Women with Metastatic Breast Cancer

Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)
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Nearest Location:
2406 miles
UNC Chapel Hill
Chapel Hill, NC

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07068477

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Phase NA

2

Studying Genetic and Molecular Biomarkers of Breast Cancer in <span class="highlight">Black</span> Women or Men

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers

Purpose: To study genetic and molecular biomarkers of breast cancer in individuals of African ancestry.

Who is this for?: <span class="highlight">Black</span> women or men with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood and tumor tissues</li> <li class="seamTextUnorderedListItem">Receive genetic testing</li> <li class="seamTextUnorderedListItem">Complete social determinants of health (SDOH) survey</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will also identify the effects of social determinants of health (SDOH) and lifestyle factors on breast cancer mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05754658' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html#:~:text=Social%20determinants%20of%20health%20(SDOH)%20are%20the%20nonmedical%20factors%20that,live%2C%20worship%2C%20and%20age.' target='_blank'>Centers for Disease Control and Prevention: Social Determinants of Health (SDOH)</a> </li></ul>
2

Studying Genetic and Molecular Biomarkers of Breast Cancer in <span class="highlight">Black</span> Women or Men

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
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Nearest Location:
2521 miles
Fox Chase Cancer Center
Philadelphia, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05754658

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Phase NA

3

Community Navigator to Provide Support Services to <span class="highlight">Black</span> and Latina Women with Metastatic Breast Cancer

Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Purpose: To study the ability of a community navigator to provide supportive care for <span class="highlight">Black</span> and Latina women with metastatic breast cancer.

Who is this for?: African American/Black and Latina women with stage IV (metastatic) breast cancer who live in New York City, NY. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Coaching sessions with community navigator, in-person or virtual, weekly for 1.5 months</li> <li class="seamTextUnorderedListItem">Phone call check-ins, monthly for 4 months</li> <li class="seamTextUnorderedListItem">Support with scheduling supportive care visits (optional)</li> <li class="seamTextUnorderedListItem">Referrals to community resources (optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phone calls, weekly for 1.5 months</li> <li class="seamTextUnorderedListItem">Phone call check-ins, monthly for 4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Black and Latina women experience unequal access to support services and care.</li> <li class="seamTextUnorderedListItem">If you are in group 1, the navigator sessions will focus on health coaching. You have the choice to receive support with scheduling supportive care visits and/or referrals to support groups, educational workshops, and healthy lifestyle services.</li> <li class="seamTextUnorderedListItem">If you are in group 2, the phone calls will include reviewing breast cancer supportive and palliative care resources in NYC and online.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06405828' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Community Navigator to Provide Support Services to <span class="highlight">Black</span> and Latina Women with Metastatic Breast Cancer

Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer
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Nearest Location:
2569 miles
Mount Sinai Hospital
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06405828

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Phase NA

4

Clinical Trial Education and Navigation for People with Stage I-IV Breast Cancer

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Purpose: To study whether a list of clinical trials, clinical trial educational materials, and clinical trial patient navigators (CTPN) increase participation in clinical trials, especially in the <span class="highlight">Black,</span> Indigenous, and People of Color (BIPOC) community.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">List of matched clinical trials</li> <li class="seamTextUnorderedListItem">Clinical trial educational materials</li> <li class="seamTextUnorderedListItem">Clinical trial patient navigator (CTPN)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive a list of matched clinical trials and educational materials designed to inform and empower you to consider clinical trials.</li> <li class="seamTextUnorderedListItem">You will also work with a clinical trial patient navigator (CTPN) to further educate you about clinical trials.</li> <li class="seamTextUnorderedListItem">This trial is available in English and Spanish.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05146297' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Clinical Trial Education and Navigation for People with Stage I-IV Breast Cancer

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
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Nearest Location:
2569 miles
Herbert Irving Comprehensive Cancer Care Center
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05146297

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Phase NA

5

Virtual Intervention to Improve the Well-Being of <span class="highlight">Black</span> Women With Stage 0-IV Breast Cancer

Project SOAR Awakenings: Randomized Controlled Trial for <span class="highlight">Black</span> American Women Diagnosed With Breast Cancer

Purpose: To promote well-being and decrease depression and fatigue.

Who is this for?: <span class="highlight">Black</span> women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Project SOAR Gatherings, virtual, 1.5- to 2-hour discussions, weekly for 1 month</li> <li class="seamTextUnorderedListItem">Questionnaires, virtual, 3 times within 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive materials by mail for use on your own</li> <li class="seamTextUnorderedListItem">Questionnaires, virtual, 3 times within 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Project SOAR sessions are based on books and articles that participants will receive. The sessions aim to help <span class="highlight">Black</span> women accept their emotions, care for themselves, accept help from others, and manage stress.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07208084' target='_blank'>ClinicalTrials.gov</a> </li></ul>
5

Virtual Intervention to Improve the Well-Being of <span class="highlight">Black</span> Women With Stage 0-IV Breast Cancer

Project SOAR Awakenings: Randomized Controlled Trial for <span class="highlight">Black</span> American Women Diagnosed With Breast Cancer
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT07208084

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Phase NA

6

Fasting at Night to Improve Cognition After Chemotherapy for People with Stage I-IV Breast Cancer

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)

Purpose: To study how fasting at night affects health, quality of life, and cognitive ability.

Who is this for?: Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who completed chemotherapy at least 3 months ago and who are having cognitive (thinking) problems. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fast at night, 6 nights every week for 2 months</li> <li class="seamTextUnorderedListItem">Health education videos, weekly for 2 months</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 2 months</li> <li class="seamTextUnorderedListItem">Surveys, 2 times in 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Health education videos, weekly for 2 months</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 2 months</li> <li class="seamTextUnorderedListItem">Surveys, 2 times in 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">When you are fasting, you are still allowed to drink water, coffee, and tea.</li> <li class="seamTextUnorderedListItem">Cognitive problems are problems with thinking (cognition).</li> <li class="seamTextUnorderedListItem">This trial's enrollment will be racially diverse (at least 50% of participants will be <span class="highlight">Black,</span> Hispanic, and/or Native American).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06938555' target='_blank'>ClinicalTrials.gov</a> </li></ul>
6

Fasting at Night to Improve Cognition After Chemotherapy for People with Stage I-IV Breast Cancer

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06938555

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Phase NA

7

Coaching Program to Reduce Stress and Promote Resilience for People with Metastatic Breast Cancer

Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC PRISMMBC)

Purpose: To study the ability of the PRISM program to reduce stress and improve resilience for people with metastatic breast cancer.

Who is this for?: People with stage IV (metastatic) breast cancer who were diagnosed with metastatic disease in the last 6 months. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Promoting Resilience in Women with Breast Cancer (PRISM) program, virtual, 4 sessions in 1-2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Promoting Resilience in Women with Breast Cancer (PRISM) program helps improve 4 areas of resilience: stress management, goal setting, cognitive reframing, and meaning-making.</li> <li class="seamTextUnorderedListItem">This study will compare the resilience of <span class="highlight">Black</span> women to non-Black women.</li> <li class="seamTextUnorderedListItem">It also includes an optional family session.</li> <li class="seamTextUnorderedListItem">Each session is 30-60 minutes every 1-2 weeks.</li> <li class="seamTextUnorderedListItem">Black women with MBC have worse outcomes than white women with MBC because of social determinants of health (SDOH).</li> <li class="seamTextUnorderedListItem">Social determinants of health (SDOH) describe non-medical factors that influence your health, such as race, gender identity, education, occupation, transportation, food and health access, medication affordability, safety at home, housing, and financial stability.</li> <li class="seamTextUnorderedListItem">Reducing stress and improving resilience during MBC treatment may improve quality of life and even improve disease outcomes.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06855654' target='_blank'>ClinicalTrials.gov</a> </li></ul>
7

Coaching Program to Reduce Stress and Promote Resilience for People with Metastatic Breast Cancer

Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC PRISMMBC)
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06855654

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Phase NA

8

Online Portal to Educate and Refer Racially Diverse People to Clinical Trials

Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida

Purpose: To study the tailored ALEX (Agent Leveraging Empathy for eXams) Research Portal to navigate <span class="highlight">Black</span> and Hispanic adults with cancer and their family members through referral to cancer clinical trials.

Who is this for?: People who are <span class="highlight">Black,</span> African American, Hispanic, and/or Latinx. People with cancer and their family members may enroll in this trial. You must live in Florida. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ALEX (Agent Leveraging Empathy for eXams) portal</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care portal</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Racial and ethnic minorities are underrepresented in cancer clinical trials.</li> <li class="seamTextUnorderedListItem">The ALEX (Agent Leveraging Empathy for eXams) Research Portal uses culturally responsive, virtual community health educators to reach diverse populations.</li> <li class="seamTextUnorderedListItem">Clinicians can utilize the ALEX portal to refer patients to trials. Community health educators can use the portal to help provide information to patients and schedule follow-ups. Patients and family members can use the portal to access key information and make referrals.</li> <li class="seamTextUnorderedListItem">The standard of care portal provides participants with access to existing online cancer clinical trial resources in one location.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05655494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/diversity-in-clinical-trials-2/' target='_blank'>Steps Toward Expanding Eligibility Criteria to Increase Diversity in Clinical Trials</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/diversity-in-clinical-trials/' target='_blank'>The Lack of Diversity in Clinical Trials</a> </li></ul>
8

Online Portal to Educate and Refer Racially Diverse People to Clinical Trials

Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT05655494

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Phase NA

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