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Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue

NCT01247532 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-11-30

No results posted yet for this study

Summary

The purposes of the proposed study are (1) to collect data on the feasibility of offering Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce fatigue and psychological distress in cancer patients who are not in active treatment for their cancer and (2) to estimate effect sizes of the intervention for fatigue, depression, anxiety, and sleep disturbance. The investigators also will obtain preliminary effect sizes of the degree to which the intervention increases mindfulness, and the investigators will evaluate dosage effects. Findings will suggest whether a future randomized controlled trial with cancer-related fatigue (CRF) as the primary outcome is feasible and warranted.

Participants will be randomly assigned to either the MBSR intervention arm or to a wait-list control arm. The MBSR intervention will consist of a weekly 2-hour class to be held for seven consecutive weeks in the Indiana University Simon Cancer Center Pavilion; the class on week six will be extended to a 3-hour "retreat." Participants will be invited to engage in daily home practice of meditation and other mindfulness exercises. All participants will complete a series of self-report questionnaires prior to the start of the classes, immediately following the end of classes, and 1 month after the class ends. Those in the intervention arm will begin the MBSR class the week after enrollment; the control group will be offered the same 7-week program after 1-month post-intervention follow-up assessments are completed-approximately 13 weeks after enrollment.

Primary Aim 1: Obtain preliminary RCT effect sizes for changes in fatigue of an MBSR treatment group compared to a wait-list control group.

Hypothesis 1: Immediately post-intervention (T2), improvements in fatigue compared to pre-intervention (T1) will be greater in the treatment group than the control group.

Hypothesis 2: At 1 month post intervention (T3), improvements in fatigue compared to pre-intervention (T1) will be greater in the treatment group than improvements in the control group.

Conditions

Interventions

BEHAVIORAL

Mindfulness-Based Stress Reduction - Cancer-Related Fatigue

7 week 2 hour class

Sponsors & Collaborators

  • Walther Cancer Institute

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Kurt Kroenke, MD · Indiana University School of Medicine

  • Shelley Johns, PsyD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247532 on ClinicalTrials.gov