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

NCT01919853 | Completed

• 2 other identifiers: 012060089510106.01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 4

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.

Conditions

Fatigue

Keywords

Cancer; Fatigue; Mindfulness; Meditation; Neoplasms; Signs and symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  from baseline to 6 month follow-up

Secondary Outcomes (8)

• Change in cancer-related fatigue severity

  from baseline to 6 month follow-up

• Change in vitality

  from baseline to 6 month follow-up

• Change in depression

  from baseline to 6 month follow-up

• Change in anxiety

  from baseline to 6 month follow-up

• Change in sleep disturbance

  from baseline to 6 month follow-up

Other Outcomes (2)

• Change in mindfulness

  from baseline to 6 month follow-up

• Change in self-compassion

  from baseline to 6 month follow-up

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction

Attention Control

ACTIVE COMPARATOR

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.

Behavioral: Attention Control

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

Also known as: MBSR

Mindfulness-Based Stress Reduction

Attention Control BEHAVIORAL

Also known as: Education/support group

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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)

Sponsors & Collaborators

• Indiana University: lead
• Walther Cancer Institute: collaborator
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (4)

Community Health Network--Community North and Carmel Pavilion

Carmel, Indiana, 46032, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Invoke Yoga Studio

Indianapolis, Indiana, 46202, United States

Location

Ransburg YMCA

Indianapolis, Indiana, 46219, United States

Location

MeSH Terms

Conditions

Fatigue; Neoplasms; Signs and Symptoms

Interventions

Mindfulness-Based Stress Reduction; Educational Status; Self-Help Groups

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics; Organizations; Health Care Economics and Organizations

Study Officials

• Shelley Johns, PsyD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 9, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

US (4)