Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | December 2015 |
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
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.
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.
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.
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.
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%
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