Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarke… (NCT01919853) | Clinical Trial Compass
CompletedNot Applicable
Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
United States107 participantsStarted 2012-09
Plain-language summary
The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction (MBSR) to an attention control psycho-educational support group in treating cancer-related fatigue (CRF) in early-stage (0-III) post-treatment cancer survivors with clinically-significant CRF. The study will collect, store, and later analyze blood and urine samples for several biomarkers that may be linked to persistent CRF in cancer survivors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for breast cancer participants:
* be age 18 or older
* live in the Indianapolis region
* have an established first-time diagnosis of non-metastatic (stages 0-III) breast cancer treated with chemotherapy and/or radiation therapy
* be in good general health (self-report)
* have clinically-significant CRF (Fatigue Symptom Inventory \[FSI severity composite ≥ 4\]) that has persisted for the previous 8 weeks or longer.
Inclusion Criteria for colorectal cancer participants:
* be age 18 or older
* live in the Indianapolis region
* have an established diagnosis of colorectal cancer (any stage)
* in treatment currently or previously with chemotherapy and/or radiation therapy
* have clinically-significant CRF (Fatigue Symptom Inventory \[FSI severity composite ≥ 4) that has persisted for the previous 8 weeks or longer.
Exclusion Criteria for breast cancer participants:
* cancer treatment (chemotherapy, biologic response modifiers, radiation therapy, or surgery) in prior 3 months or \> 5 years ago (endocrine therapy for breast cancer is allowed)
* enrollment in hospice care
* severe depression (PHQ-8 ≥ 20)
* past participation in a mindfulness meditation class and/or having an established/ongoing meditation practice
Exclusion Criteria for colorectal cancer participants:
* enrollment in hospice care
* severe depression (PHQ-8 ≥ 20)
* past participation in a mindfulness meditation class and/or having an established/ongoing meditation practice
A non-fatigued grou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cancer-related fatigue functional interference