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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:
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

Headband and Meditation for Improving Anxiety and Insomnia for People with Stage I-IV Breast Cancer

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

Purpose: To study the ability of the MUSE S headband and MUSE phone app to reduce anxiety and insomnia.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed within the last 10 years. You must be experiencing anxiety and insomnia (sleep problems). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MUSE S headband, nightly for 2 months</li> <li class="seamTextUnorderedListItem">Meditation with MUSE phone app, for at least 5 minutes daily, for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anxiety and insomnia (sleep problems) are among the most common side effects of breast cancer.</li> <li class="seamTextUnorderedListItem">Meditation is an effective tool to decrease stress and anxiety.</li> <li class="seamTextUnorderedListItem">The MUSE S headband sends EEG signals to your brain to improve <span class="highlight">fatigue,</span> quality of life, and stress.</li> <li class="seamTextUnorderedListItem">You will be asked to wear the MUSE S headband to bed every night and meditate using the MUSE phone app for at least 5 minutes every day.</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/NCT06274034' target='_blank'>ClinicalTrials.gov</a> </li></ul>
2

Headband and Meditation for Improving Anxiety and Insomnia for People with Stage I-IV Breast Cancer

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Number of visits unavailable, over 2 months

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ClinicalTrials.gov: NCT06274034

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Phase I

3

Studying the Relationship Between Heart Rate Variability and <span class="highlight">Fatigue</span> During Treatment for Stage I-IV Breast Cancer

Wearable Activity Tracker Devices and Cancer-Related <span class="highlight">Fatigue:</span> A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment

Purpose: To study the relationship between heart rate variability (HRV) and <span class="highlight">fatigue</span> during cancer treatment.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive or are receiving treatment. You must be experiencing <span class="highlight">fatigue</span> (tiredness). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Wear activity tracker device, 1 month</li> <li class="seamTextUnorderedListItem">Diary of activity tracker information, 1 month</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The activity tracker device measures your heart rate variability (HRV).</li> <li class="seamTextUnorderedListItem">Heart rate variability (HRV) is the fluctuations in the amount of time between your heartbeats.</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/NCT06291324' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/symptoms/21773-heart-rate-variability-hrv' target='_blank'>Cleveland Clinic: Heart Rate Variability</a> </li></ul>
3

Studying the Relationship Between Heart Rate Variability and <span class="highlight">Fatigue</span> During Treatment for Stage I-IV Breast Cancer

Wearable Activity Tracker Devices and Cancer-Related <span class="highlight">Fatigue:</span> A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment
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Nearest Location:
2300 miles
Levine Cancer Institute
Charlotte, NC

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Visits:
At least 3 visits within 1 month

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ClinicalTrials.gov: NCT06291324

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Phase NA

4

Virtual Program to Improve Sleep Problems and Symptoms for Women With Stage 0-IV Breast Cancer

Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas

Purpose: To study a virtual mindfulness-based program called Nite2Day that is designed to improve sleep and help people manage symptoms.

Who is this for?: Women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who received their diagnosis within the last year and who are having trouble sleeping. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nite2Day program, virtual, 45- to 60-minute sessions, weekly for 1.5 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Women with breast cancer often experience trouble sleeping, <span class="highlight">fatigue,</span> stress, and pain.</li> <li class="seamTextUnorderedListItem">In this study, participants will learn strategies to help them cope with trouble sleeping and daytime symptoms of <span class="highlight">fatigue,</span> stress, and pain.</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/NCT06529120' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Virtual Program to Improve Sleep Problems and Symptoms for Women With Stage 0-IV Breast Cancer

Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
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Nearest Location:
2383 miles
Scotland Health Care System
Laurinburg, NC

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Visits:
Number of visits unavailable, 3 months

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ClinicalTrials.gov: NCT06529120

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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:
2389 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:
2592 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

8

Integrative Medicine at Home Program for People With Stage I-IV Breast Cancer

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)

Purpose: To find out whether the Integrative Medicine at Home program can help reduce symptoms and improve treatment satisfaction.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are currently receiving treatment. 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">Integrative Medicine at Home program, 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Enhanced Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Integrative medicine handout</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Integrative Medicine at Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice.</li> <li class="seamTextUnorderedListItem">Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind and reduce symptoms such as tiredness <span class="highlight">(fatigue),</span> pain, or insomnia (sleep problems).</li> <li class="seamTextUnorderedListItem">The classes will be led by an Integrative Medicine Service (IMS) clinical therapist using Zoom video conferencing platform.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will be given a handout to encourage you to visit Memorial Sloan Kettering's Integrative Medicine website to access pre-recorded, on-demand meditation videos and audios.</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/NCT05053230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine' target='_blank'>Memorial Sloan Kettering Cancer Center: Integrative Medicine</a> </li></ul>
8

Integrative Medicine at Home Program for People With Stage I-IV Breast Cancer

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT05053230

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Phase NA

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