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

NCT ID: NCT01919853

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-11-30

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Stress Reduction

The MBSR intervention is an 8-week course meeting 2 hours weekly. The curriculum is based on MBSR manuals with a brief CRF education component incorporated into the first and second class sessions, drawing from information from the National Comprehensive Cancer Network clinical practice guidelines for CRF. In general, the MBSR class includes guided meditation practice; mindful, gentle movement (hatha yoga); didactic material on self-regulatory responses to stress; and group discussion that includes the participants' growing incorporation of mindfulness in adapting to life experiences. Along with class time, each participant is asked to commit 20 minutes per day, six days per week to formal meditation practice using compact disk recordings of the teacher's voice.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

Attention Control

The attention control is an 8-week class meeting 2 hours weekly. The group sessions are supportive in tone, focus on pre-designated topics relevant to fatigue management (e.g., sleep hygiene, nutrition, exercise, emotional regulation), and involve weekly readings and open group discussion about session topics. This condition contains "non-specific" factors similar to MBSR (e.g., facilitator offering participants compassionate attention, empathy, genuine caring, and an opportunity to discuss what is important to them in a supportive environment); however, mindfulness is not presented/practiced in the group.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

Interventions

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

Attention Control

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR; Education/support group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• 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

• 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

• 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.

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walther Cancer Institute

OTHER

Sponsor Role: collaborator

Indiana Clinical and Translational Sciences Institute

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Shelley Johns

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shelley Johns, PsyD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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

Countries

United States

Other Identifiers

0106.01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01206008951

Identifier Type: -

Identifier Source: org_study_id