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:

• they have a cancer diagnosis
• are age 18 or older
• 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:

• chemotherapy, biologic response modifiers, radiation therapy, or surgery in prior 3 months
• enrollment in hospice care
• severe hearing impairment
• severe depression (PHQ-8 ≥ 15)
• past participation in a mindfulness meditation class
• incapable of reading and writing English. Each of these characteristics will be assessed as part of the eligibility screening interview.