Fatigue Intervention Trial for Breast Cancer Survivors

NCT00513136 | Completed Phase 3

• 1 other identifier: MMC2007-46
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery. The investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.

Conditions

Fatigue

Keywords

Fatigue; Breast Cancer; Behavioral Research; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Change from baseline to end-of-intervention and 2 and 6 months post-intervention

Secondary Outcomes (1)

• Quality of Life; Mood; Social Support

  Change from baseline to end-of-intervention and 2 and 6 months post intervention

Study Arms (2)

I

ACTIVE COMPARATOR

10 week group-based mind body medicine intervention

Behavioral: Group based mind body medicine intervention

II

EXPERIMENTAL

Group-based mind body medicine intervention with a family focus

Behavioral: Group-based mind body medicine intervention + family focus

Interventions

Group based mind body medicine intervention BEHAVIORAL

Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns

I

Group-based mind body medicine intervention + family focus BEHAVIORAL

In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.

II

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I-III Breast Cancer
• At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
• week history of persistent moderate to severe fatigue
• Competent to sign informed consent
• Willing to be randomized

You may not qualify if:

• Metastatic breast cancer

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Fatigue; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathy J Helzlsouer, MD, MHS

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

• Julianne Oktay, PhD, MSW

  University of Maryland School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administration

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (1)