Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue

NCT01247532 | Completed Phase 1 DMC

• 3 other identifiers: IRB-01 Study 1003-02BR25CA117865-01A11R25CA117865-01
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cancer; Fatigue

Keywords

Cancer; Fatigue; Mindfulness; Meditation; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Fatigue Symptom Inventory Interference Subscale

  Last 7 days

Study Arms (1)

Waitlist

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction - Cancer-Related Fatigue

Interventions

Mindfulness-Based Stress Reduction - Cancer-Related Fatigue BEHAVIORAL

7 week 2 hour class

Also known as: MBSR

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Walther Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kurt Kroenke, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Shelley Johns, PsyD

  Indiana University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 30, 2010

Record last verified: 2010-11