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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

About this study

Exercise behavior will be defined as patient reported mean total minutes (frequency x duration) of mild, moderate, and vigorous-intensity physical exercise per week over the past month at baseline (prior to enrollment in the study). In addition we will collect patient reported mean total minutes per week of mild, moderate, and vigorous-intensity physical exercise over the course of radiation therapy.Baseline characteristics including demographic data (age, education, employment) as well as BMI, waist to hip ratio, and health comorbidities (including smoking status, cardiovascular disease, and diabetes) will also be collected. BMI and health comorbidities will be extracted from the chart. Patient-Reported Outcomes will include QOL, fatigue, depression, pain and sleep. QOL will be assessed using the Functional Assessment of Cancer Therapy (FACT) scale developed for the assessment of patient symptoms and QOL in cancer patients. Fatigue will be assessed using the 13-item FACT-fatigue scale for the assessment of fatigue in cancer patients.Skin toxicity will be defined as radiation dermatitis, pruritus, and pain.

Lymphedema will be assessed by measuring limb girth. Measurements will be taken by first marking both limbs while patient is lying supine, starting at the ulnar styloid at 5cm intervals on the length of the arms. The diameter of the limb will then be measured at these markings. Based on these measurements, the affected limb will be compared to the unaffected limb. Range of motion will be defined as reduced abduction compared to the contralateral shoulder . All measurements will be taken with a goniometer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
18 years of age or older
Signed study-specific informed consent

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 24 months

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).

Secondary outcomes

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

Time frame: 24 months

Acute radiation related toxicities will include assessments of radiation dermatitis , range of motion and lymphedema.Skin toxicity will be defined as radiation dermatitis, pruritus, and pain. It will be evaluated using the National Cancer Institute Common Terminology Criteria of Adverse Events v4.0 (NCI, 2010).

Lymphedema will be assessed by measuring limb girth. Measurements will be taken by first marking both limbs while patient is lying supine, starting at the ulnar styloid at 5cm intervals on the length of the arms. The diameter of the limb will then be measured at these markings. Based on these measurements, the affected limb will be compared to the unaffected limb. Lymphedema will be classified according to the American System: Mild 1.5-3.0 cm; Moderate 3.1-5.0 cm; Severe > 5.0 cm.(Markowski, Wilcox, & Helm, 1981) Range of motion will be defined as reduced abduction compared to the contralateral shoulder . All measurements will be taken with a goniometer.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Pilot Study to Examine the Association Between Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 31, 2014
Registry last updated: Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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