Status:
COMPLETED
Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Walther Cancer Institute
Indiana Clinical and Translational Sciences Institute
Conditions:
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ea...
Detailed Description
This is a randomized, attention control clinical trial to compare MBSR to support and education on biobehavioral outcomes in early-stage (0-III) post-treatment cancer survivors with clinically-signifi...
Eligibility Criteria
Inclusion
- 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 group of post-treatment BCS will also be enrolled in order to compare baseline levels of all biomarkers and all self-reported psychosocial measures between fatigued and non-fatigued BCS.
- Inclusion criteria for non-fatigued BCS participants
- being age 18 or older
- having an established first-time diagnosis of non-metastatic (stage 0-III) breast cancer
- being in good general health (self-reported)
- having FSI severity composite scores of ≤ 2
- Exclusion criteria for non-fatigued BCS 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)
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01919853
Start Date
September 1 2012
End Date
November 1 2013
Last Update
July 2 2025
Active Locations (4)
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1
Community Health Network--Community North and Carmel Pavilion
Carmel, Indiana, United States, 46032
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Invoke Yoga Studio
Indianapolis, Indiana, United States, 46202
4
Ransburg YMCA
Indianapolis, Indiana, United States, 46219