Fatigue Clinical Trial
Official title:
Treatment for Breast and Colorectal Cancer Survivors With Persistent Cancer-Related Fatigue: A Randomized Controlled Trial
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.
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-significant CRF. The study will use quantitative and qualitative methods to
evaluate the following:
Primary Aim 1: Determine effect size estimates of MBSR compared to attention control in
reducing fatigue interference and the severity of several cancer-related symptoms
immediately post-intervention and at 6-month follow-up.
Exploratory Aim 1: To identify potential moderators of intervention effects in breast cancer
survivors (BCS) and colorectal cancer survivors (CRCS), such as demographic,
clinical/disease characteristics, personality traits, and baseline mindfulness level.
Exploratory Aim 2: To compare levels of a number of anti- and pro-inflammatory proteins
present in blood and urine between MBSR and attention control groups immediately
post-intervention and 6-month follow-up, and between fatigued and non-fatigued breast cancer
survivors at baseline.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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