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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NCI
interventional
35
0 countries
N/A
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 2010
Actual (reported)October 2010
Actual (reported)November 23, 2010
Actual (reported)November 24, 2010
Actual (reported)Fatigue Symptom Inventory Interference Subscale
Last 7 days
7 week 2 hour class
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kurt Kroenke, MD
Indiana University
Shelley Johns, PsyD
Indiana University
35 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
November 30, 2010
Record last verified: 2010-11
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Source: ClinicalTrials.gov.
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