Cancer Clinical Trial
Official title:
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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