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

N/ACompletedNCT01919853

Indiana University107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Fatigue

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

Attention ControlBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

Change in cancer-related fatigue functional interference

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.