An Intervention to Decrease Fatigue Among Breast Cancer Survivors

NCT00273208 | Completed

• 1 other identifier: MMC 2005-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is being done to design and then test whether a 10 week program can help reduce the symptoms of being tired and fatigued among women who have had breast cancer. The pilot study will include 4 groups of women, two groups of women from Baltimore and two groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The purpose of this pilot study is to help us find the best things to include in the program to help women who have had breast cancer and who have severe problems with fatigue that has lasted months to years after being treated with chemotherapy or radiation therapy. Following the pilot program we will conduct and evaluate (using a quasi-experimental design comparing fatigue scores before and after the intervention) the efficacy of the refined 10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast cancer survivors who have completed their adjuvant therapy. Four intervention groups (\~12 women per group) will be conducted: two in the urban setting and two in the rural setting. We will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6 months following completion of the program. We will compare mean baseline scores to post-intervention scores. The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for improving symptoms of fatigue and thus improving quality of life among breast cancer survivors

Conditions

Fatigue After Adjuvant Breast Cancer Treatment

Keywords

breast cancer; fatigue

Outcome Measures

Primary Outcomes (1)

• change in fatigue score

Interventions

10 week behavioral intervention program BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• moderate to severe fatigue \>6 months after last chemotherapy or radiation treatment \>5 years from diagnosis

You may not qualify if:

• Metastatic disease-

Sponsors & Collaborators

• Mercy Medical Center: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathy J Helzlsouer, M.D., M.H.S.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: September 1, 2005
• Study Completion: April 1, 2007
• Last Updated: August 2, 2007

Record last verified: 2007-08

Locations

US (1)