Status:
COMPLETED
Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Walther Cancer Institute
National Cancer Institute (NCI)
Conditions:
Cancer
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 c...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01247532
Start Date
March 1 2010
End Date
October 1 2010
Last Update
November 30 2010
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