Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response

Not Applicable

Completed

• Conditions: Fatigue

• Registration Number: NCT01919853
• Lead Sponsor: Indiana University

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 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.

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-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.

Study Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Primary Completion: 2013-11
• Study Completion: 2013-11-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-28
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cancer-related fatigue functional interference	from baseline to 6 month follow-up	The Fatigue Symptom Inventory interference subscale will be used to assess the degree to which CRF was judged to interfere with quality of life across seven domains over the previous week.

Secondary Outcome Measures

Name	Time	Method
Change in fear of recurrence	from baseline to 6 month follow-up	The Concerns About Recurrence Scale will be used to assess overall frequency, potential for upset, consistency, and intensity of recurrence fears.
Change in cancer-related fatigue severity	from baseline to 6 month follow-up	The Fatigue Symptom Inventory severity subscale will be used to assess the most, least, and average fatigue in the past week, as well as current fatigue.
Change in vitality	from baseline to 6 month follow-up	The Short Form (36) Health Survey Vitality Scale will be used to assess how much during the past 4 weeks the person had a lot of energy, felt full of life, felt worn out, and felt tired.
Change in depression	from baseline to 6 month follow-up	The PHQ-8 scale will be used to assess how often the person has been bothered over the previous 2 weeks by symptoms of depression, including little interest or pleasure in doing things and feeling down, depressed, or hopeless.
Change in attentional function	from baseline to 6 month follow-up	The Attentional Function Index will be used to assess perceived effectiveness in common activities requiring attention and working memory.
Change in anxiety	from baseline to 6 month follow-up	The GAD-7 scale will be used to assess how often the person has been bothered over the previous 2 weeks by symptoms such as: feeling nervous, anxious, or on edge; not being able to stop or control worrying; and trouble relaxing.
Change in sleep disturbance	from baseline to 6 month follow-up	The Insomnia Severity Index will be used to assess the perceived severity of insomnia and the impact of sleep difficulties over the previous 2 weeks.
Change in pain	from baseline to 6 month follow-up	The Brief Pain Inventory-3 is a brief pain measure derived from the Brief Pain Inventory. It is also known as the PEG and will be used to assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) over the past week.

Trial Locations

Locations (4)

Community Health Network--Community North and Carmel Pavilion; 🇺🇸 Carmel, Indiana, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Invoke Yoga Studio; 🇺🇸 Indianapolis, Indiana, United States

Ransburg YMCA; 🇺🇸 Indianapolis, Indiana, United States