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

NCT ID: NCT01247532

Last Updated: 2010-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-10-31

Brief 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.

Detailed Description

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).

Conditions

Cancer; Fatigue

Keywords

Cancer; Fatigue; Mindfulness; Meditation; Neoplasms

Study Design

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

Study Groups

Waitlist

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction - Cancer-Related Fatigue

Intervention Type: BEHAVIORAL

7 week 2 hour class

Interventions

Mindfulness-Based Stress Reduction - Cancer-Related Fatigue

7 week 2 hour class

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

Eligibility Criteria

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.

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

Sponsors

Walther Cancer Institute

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Indiana University

Principal Investigators

Kurt Kroenke, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Shelley Johns, PsyD

Role: STUDY_DIRECTOR

Indiana University School of Medicine

Other Identifiers

R25CA117865-01A11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R25CA117865-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-01 Study 1003-02B

Identifier Type: -

Identifier Source: org_study_id