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
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
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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Fatigue Symptom Inventory Interference Subscale
Last 7 days
Kurt Kroenke, MD
Indiana University School of Medicine
United States: Institutional Review Board
IRB-01 Study 1003-02B