Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer

NCT02050620 | Completed

• 1 other identifier: Pro00050716
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Using an observational prospective design, potential subjects will be identified and screened for eligibility via medical record review of breast cancer patients scheduled for radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to complete study questionaires prior to the start of radiation therapy and again during the last week of therapy.

Conditions

Breast Cancer

Keywords

Breast cancer, exercise and quality of life

Outcome Measures

Primary Outcomes (1)

• To measure in composite the association between self reported exercise behaviour and patient reported outcomes of quality of life.

  Quality of life outcomes will be measured by patient self reported levels of fatigue, sleep, pain and depression. Patient-Reported Outcomes will include QOL, fatigue, depression, pain and sleep. QOL will be assessed using the Functional Assessment of Cancer Therapy (FACT) scale. Fatigue will be assessed using the 13-item FACT-fatigue scale. Beck depression inventory (BDI) will be used to evaluate for underlying depressive symptoms. We will use the revised version (BDI-II) and the scores will range from 0 (no depression) to 63 (severe depression) (Beck et al., 1996) Pain will be assessed using the previously validated shortened Brief Pain Inventory (BPI) (Cleeland \& Ryan, 1994). Sleep will be measured using the previously validated Pittsburgh Sleep Inventory (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989).

  24 months

Secondary Outcomes (1)

• To measure in composite the association between self-reported exercise behavior and acute radiation related toxicities.

  24 months

Eligibility Criteria

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

Study Population

Subjects with biopsy proven ductal carcinoma in situ or invasive breast carcinoma scheduled to receive definitive treatment in the Department of Radiation Oncology at Duke will be potentially eligible for this study.

You may qualify if:

• Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma
• Definitive radiation treatment planned to the chest and/or regional nodes
• years of age or older
• Signed study-specific informed consent

You may not qualify if:

• Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate
• Karnofsky Performance Status (KPS) \< 70%

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Janet K Horton, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)