Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue
18 Years
N/A
Both
Cancer, Fatigue
Trial Information
Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Fatigue Symptom Inventory Interference Subscale
Outcome Time Frame:
Last 7 days
Safety Issue:
No
Principal Investigator
Kurt Kroenke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Indiana University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
IRB-01 Study 1003-02B
NCT ID:
NCT01247532
Start Date:
March 2010
Completion Date:
October 2010
Related Keywords:
- Cancer
- Fatigue
- Cancer
- Fatigue
- Mindfulness
- Meditation
- Neoplasms
- Fatigue
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