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

This study has been completed.
Sponsor:
Collaborators:
Walther Cancer Institute
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01247532
First received: November 23, 2010
Last updated: November 29, 2010
Last verified: November 2010

November 23, 2010
November 29, 2010
March 2010
October 2010   (final data collection date for primary outcome measure)
Fatigue Symptom Inventory Interference Subscale [ Time Frame: Last 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01247532 on ClinicalTrials.gov Archive Site
Not Provided
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Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue
Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue

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.

Secondary Aim 1: Obtain preliminary randomized controlled trial (RCT) effect sizes for changes in depression, anxiety, and sleep disturbance of an MBSR treatment group compared to a wait-list control group.

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

Secondary Aim 2: Obtain preliminary effect sizes of the degree to which the intervention increases mindfulness and of the relationship of mindfulness with fatigue, depression, anxiety, and sleep disturbance.

Hypothesis 1: At T2 and 30-days post-intervention (T3), improvements in mindfulness compared to pre-intervention (T1) will be greater in the treatment group than in the control group.

Hypothesis 2: Degree of mindfulness will be negatively correlated with fatigue, depression, anxiety, and sleep disturbance at all time-points.

Secondary Aim 3: Evaluate the feasibility of recruiting fatigued cancer patients to participate in MBSR-CRF, as well as the acceptability and dosage effects of MBSR-CRF.

Hypothesis 1: At least 30% of patients who meet study criteria will choose to enroll in the proposed study.

Hypothesis 2: The MBSR intervention protocol will demonstrate feasibility in that (1) at least 70% of participants will attend at least 4 of the 7 scheduled classes, and (2) at least 70% of participants will practice mindfulness at least 60 minutes per week.

Hypothesis 3: Class attendance and hours of mindfulness practice per week will be positively associated as indicated by correlation effect sizes with improvements in both the process variable (degree of mindfulness) as well as the primary outcome variable (i.e., fatigue) and secondary outcome variables (i.e., depression, anxiety, and sleep disturbance).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cancer
  • Fatigue
Behavioral: Mindfulness-Based Stress Reduction - Cancer-Related Fatigue
7 week 2 hour class
Other Name: MBSR
Experimental: Waitlist
Intervention: Behavioral: Mindfulness-Based Stress Reduction - Cancer-Related Fatigue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals will be eligible to participate based on the following criteria:

    1. they have a cancer diagnosis
    2. are age 18 or older
    3. have clinically significant cancer-related fatigue (CRF) that has persisted for the previous 8 weeks or longer. Clinically significant CRF will be defined by a cutoff mean score of ≥ 4 across the 3-item Fatigue Symptom Inventory severity composite.

Exclusion Criteria:

  • Participants will be excluded based on the following criteria:

    1. chemotherapy, biologic response modifiers, radiation therapy, or surgery in prior 3 months
    2. enrollment in hospice care
    3. severe hearing impairment
    4. severe depression (PHQ-8 ≥ 15)
    5. past participation in a mindfulness meditation class
    6. incapable of reading and writing English. Each of these characteristics will be assessed as part of the eligibility screening interview.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01247532
IRB-01 Study 1003-02B, R25CA117865-01A11
Yes
Kurt Kroenke, Indiana University
Indiana University
  • Walther Cancer Institute
  • National Cancer Institute (NCI)
Principal Investigator: Kurt Kroenke, MD Indiana University School of Medicine
Study Director: Shelley Johns, PsyD Indiana University School of Medicine
Indiana University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP