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1

Exercise for <span class="highlight">Fatigue</span> for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Purpose: To study the safety and effects (good and bad) of a home-based, unsupervised exercise program for cancer-related <span class="highlight">fatigue.</span>

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2-low, or hormone receptor-positive (HR+), HER2-low or HER2-ultralow breast cancer who are receiving trastuzumab deruxtecan (Enhertu®) and experiencing <span class="highlight">fatigue.</span> You must not be participating in an exercise program as defined by the study investigators. 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">Exercise program, at home, for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No exercise</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The exercise program is an individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise program.</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/NCT07203378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/special-topics/enhertu-hrpos-her2low/' target='_blank'>Metastatic Trial Talk: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/fatigue-2/' target='_blank'>Metastatic Trial Talk: Fatigue</a> </li></ul>
1

Exercise for <span class="highlight">Fatigue</span> for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
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Nearest Location from 94107:
602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

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Visits:
Number of visits unavailable, 3 months

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ClinicalTrials.gov: NCT07203378

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Phase II

2

Symptom Management and Coaching for People with Metastatic Breast Cancer and Their Caregivers

Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers

Purpose: To find out whether adding telephone health coaching to a printed symptom management handbook helps lower the burden of common cancer symptoms and improve quality of life, compared with the handbook alone. .

Who is this for?: People with metastatic (stage IV) breast cancer, along with a caregiver of their choice such as a spouse, family member, or friend. Caregivers must be 18 or older, have telephone access, and not currently be treated for cancer. This trial is also enrolling people with other types of cancer. 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Symptom Management and Survivorship Handbook </li> <li class="seamTextUnorderedListItem">Telephone call, once a week for 10 weeks to check on your symptoms and point you to helpful chapters in the handbook</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Symptom Management and Survivorship Handbook . </li> <li class="seamTextUnorderedListItem">A trained health coach calls you and your caregiver separately by telephone, once a week for 10 weeks to check on symptoms, help set goals, and support symptom self management.</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is looking at ways to help people with metastatic cancer and their caregivers manage the physical and emotional symptoms that come with cancer. </li> <li class="seamTextUnorderedListItem">Everyone in the study receives a Symptom Management and Survivorship Handbook, a printed guide that covers 24 common symptoms such as <span class="highlight">fatigue,</span> pain, sleep problems, anxiety, and depression, along with tips for managing them and survivorship guidance. </li> <li class="seamTextUnorderedListItem">The study compares the handbook on its own with the handbook plus weekly telephone health coaching. </li> <li class="seamTextUnorderedListItem">The coaching adds one on one support to help set goals, build symptom management skills, and reduce feelings of isolation. Researchers want to learn whether the added coaching lowers symptom burden and improves quality of life.</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/NCT07415564' target='_blank'>ClinicalTrials.gov</a> </li></ul>
2

Symptom Management and Coaching for People with Metastatic Breast Cancer and Their Caregivers

Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers
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Nearest Location from 94107:
752 miles
University of Arizona Cancer Center
Tucson, AZ

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Visits:
No in person visits required

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ClinicalTrials.gov: NCT07415564

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Phase NA

3

A Virtual Group Lifestyle Program for Women with Metastatic (Stage IV) Hormone Receptor Positive, HER2 Negative Breast Cancer

Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence

Purpose: To find the best way to deliver a virtual, group based lifestyle program that supports healthy habits in diet, exercise, and stress management. The study compares different levels of support (the program on its own, the program with an online support group, and the program with an online support group plus individual health coaching) to learn which approach helps people stay involved and follow the program.

Who is this for?: Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must be receiving your first or second treatment for metastatic breast cancer. You must be receiving care at MD Anderson Cancer Center in Houston, Texas. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online lifestyle program on your own using interactive exercise and activity modules over 8 weeks, </li> <li class="seamTextUnorderedListItem">Phone call, once a week, for 8 weeks.</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online lifestyle program modules and join an online group session (called a Learning Circle) for 90 minutes once a week, for 8 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online lifestyle program modules and join an online group session (called a Learning Circle) for 90 minutes once a week, for 8 weeks</li> <li class="seamTextUnorderedListItem">About 2 weeks after that program ends, you will also receive individual health coaching sessions lasting 30 to 60 minutes, up to 6 sessions over 3 months.</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is looking at whether a virtual, group based lifestyle program can help people with metastatic breast cancer build and keep healthy habits in diet, exercise, and stress management. </li> <li class="seamTextUnorderedListItem">Researchers want to learn how much support people need to stay involved and follow the program, so they are comparing the program on its own, the program with an online support group, and the program with both an online support group and individual health coaching. </li> <li class="seamTextUnorderedListItem">The study also looks at changes in quality of life, <span class="highlight">fatigue,</span> sleep, mood, social support, mindfulness, and certain blood levels.</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/NCT07179809' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

A Virtual Group Lifestyle Program for Women with Metastatic (Stage IV) Hormone Receptor Positive, HER2 Negative Breast Cancer

Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence
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Nearest Location from 94107:
1643 miles
The University of Texas M. D. Anderson Cancer Center
Houston, TX

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Visits:
About 1 online session per week during the 8 week program

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ClinicalTrials.gov: NCT07179809

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Phase NA

4

Time-Restricted Eating During Chemotherapy for Women with Breast Cancer

Time Restricted Eating During Chemotherapy for Breast Cancer

Purpose: To study whether time-restricted eating (limiting food intake to an 8-hour window each day) is a practical and acceptable approach for women with breast cancer who are starting chemotherapy.

Who is this for?: Women with stage I, stage II, stage III, or stage IV breast cancer who are starting chemotherapy. You must not have type 1 or insulin-dependent type 2 diabetes, or be currently enrolled in a weight loss program. You must be receiving care at the University of Illinois Chicago and Robert H. Lurie Comprehensive Cancer Center in Chicago, Illinois. 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 </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will eat all your food within a self-selected 8-hour window each day (starting at 10:00 am, 11:00 am, or 12:00 pm), then fast for the remaining 16 hours</li> <li class="seamTextUnorderedListItem">You will follow this plan daily for 6 months (24 weeks).</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will follow standard nutrition recommendations for people receiving chemotherapy.</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early research suggests that fasting around the time of chemotherapy may help improve how well treatment works and reduce side effects. </li> <li class="seamTextUnorderedListItem">This study will look at whether time-restricted eating affects treatment side effects, <span class="highlight">fatigue,</span> quality of life, body weight and composition, and blood sugar and hormone levels during the 6-month study period.</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/NCT07387445' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fasting-improves-quality-of-life-during-chemo' target='_blank'>Breastcancer.org: Short-Term Fasting Improves Quality of Life During Chemotherapy</a> </li></ul>
4

Time-Restricted Eating During Chemotherapy for Women with Breast Cancer

Time Restricted Eating During Chemotherapy for Breast Cancer
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Nearest Location from 94107:
1853 miles
University of Illinois Chicago
Chicago, IL

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Visits:
Number of visits unavailable, up to 6 months.

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ClinicalTrials.gov: NCT07387445

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Phase NA

5

ENGAGE Telehealth Program to Reduce Symptoms and Improve Quality of Life for People with Metastatic Breast Cancer

Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer

Purpose: To study the ability of ENGAGE, a telehealth program, to reduce pain, <span class="highlight">fatigue,</span> and distress and improve quality of life for people with metastatic breast cancer.

Who is this for?: People with metastatic (stage IV) breast cancer who are experiencing pain, <span class="highlight">fatigue,</span> and/or distress. You must be receiving care at a Duke Cancer Network (DCN) clinic. 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">ENGAGE program, virtual, 4 sessions</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times in 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Supportive Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Supportive care program, virtual, 4 sessions</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times in 4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ENGAGE sessions use Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) approaches to manage pain, <span class="highlight">fatigue,</span> and distress.</li> <li class="seamTextUnorderedListItem">Supportive care sessions focus on education, support, and resources focused on common cancer-related concerns, such as education on symptoms, body image concerns, and financial concerns.</li> <li class="seamTextUnorderedListItem">All sessions (Group 1 and Group 2) are led by trained therapists and are 45-60 minutes long.</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/NCT06555588' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nami.org/treatment/how-i-use-act-and-cbt-to-help-people-cope-with-health-conditions/' target='_blank'>National Alliance on Mental Illness: Using ACT and CBT to Help People Cope with Health Conditions</a> </li></ul>
5

ENGAGE Telehealth Program to Reduce Symptoms and Improve Quality of Life for People with Metastatic Breast Cancer

Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer
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Nearest Location from 94107:
2388 miles
Duke Cancer Network
Durham, NC

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Visits:
3 visits in 4 months

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ClinicalTrials.gov: NCT06555588

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Phase NA

6

Fasting and/or Exercise to Reduce <span class="highlight">Fatigue</span> During Hormone Therapy for Women with Metastatic HR+ Breast Cancer

Prolonged Overnight Fasting And/or Exercise on <span class="highlight">Fatigue</span> and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)

Purpose: To study the ability of fasting and/or exercise to reduce <span class="highlight">fatigue</span> and improve other outcomes for women with advanced breast cancer who are receiving hormone therapy.

Who is this for?: Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to receive treatment (starting within 1 month) with a CDK4/6 inhibitor as the first or second line of hormone therapy for metastatic disease. You must not exercise more than 1.5 hours/week or participate in regular structured fasting. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Fasting Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Exercise Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Fasting and Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: No Fasting or Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health education sessions with health coach, virtual, every 2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">If you are in Group 1 or Group 3, you will be asked to fast (not eat or drink) after 8pm, and wait 12 to 14 hours before eating and drinking the next day. You will be asked to fast 6 nights every week (1 night off every week).</li> <li class="seamTextUnorderedListItem">If you are in Group 4, the sessions focus on general nutrition, healthy lifestyle, and quality of life, with no discussion of fasting or exercise. </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/NCT06123988' target='_blank'>ClinicalTrials.gov</a> </li></ul>
6

Fasting and/or Exercise to Reduce <span class="highlight">Fatigue</span> During Hormone Therapy for Women with Metastatic HR+ Breast Cancer

Prolonged Overnight Fasting And/or Exercise on <span class="highlight">Fatigue</span> and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)
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Nearest Location from 94107:
2591 miles
University of Miami
Miami, FL

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Visits:
At least 4 visits within 1 year

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ClinicalTrials.gov: NCT06123988

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Phase NA

7

Virtual Intervention to Improve the Well-Being of Black Women With Stage 0-IV Breast Cancer

Project SOAR Awakenings: Randomized Controlled Trial for Black American Women Diagnosed With Breast Cancer

Purpose: To promote well-being and decrease depression and <span class="highlight">fatigue.</span>

Who is this for?: Black 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 Black 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>
7

Virtual Intervention to Improve the Well-Being of Black Women With Stage 0-IV Breast Cancer

Project SOAR Awakenings: Randomized Controlled Trial for Black 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

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