Activity Coaching During Pelvic Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInova Health Care Services
About this trial
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age
Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
Has undergone modified radical or radical hysterectomy
Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
Disqualifiers
Unable to schedule and attend coaching visits
Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
Unable to perform the five-times stand test
Unstable angina
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Coaching
BehavioralAn exercise coaching program tailored for women with Stage I-IVA endometrial cancer who have undergone total or modified radical hysterectomy with surgical staging. The intervention targets a total of 8 participants who are planned to complete pelvic external beam radiation therapy as part of their adjuvant treatment.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Immediate Start GroupExperimental treatment 1 intervention
Group B: Delayed Start GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.
Time frame
Enrollment to end of follow up, up to 24 monthsSecondary outcomes
1
Change in patient-reported fatigue
Measurement of changes in the level of fatigue as reported by patients, using a Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue. FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores less fatigue and lower scores more fatigue
Time frame
Enrollment to end of follow up, up to 24 months2
Change in patient-reported bowel/urinary toxicity
Assessment of changes in the severity of bowel and urinary toxicity symptoms, as reported by patients, using Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary short form assessments. The EPIC-15 is a short-form version that includes 15 items across two domains: Urinary Function and Bowel Habits. Each item in the EPIC-15 is scored on a Likert scale, and the scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Time frame
Enrollment to end of follow up, up to 24 months3
Change in patient-reported Quality of Life (QOL)
Measurement of changes in the quality of life based on patient-reported outcomes, using Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1. It includes 29 items that assess seven key areas: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles/Activities and Pain Interference. Each question usually has five response options ranging in value from one to five. The scores are then converted to T-scores using a scoring table. Higher T-Scores for Physical Function indicate better physical functioning, Higher T-Scores for Anxiety and Depression indicate more severe symptoms. Higher T-Scores for Fatigue and Sleep Disturbance indicate more fatigue or sleep problems. Higher T-Scores in ability to participate in social roles/activities indicate better ability to participate in social roles and activities. Higher T-Scores for Pain Interference means more interference from pain in daily activities and intense pain
Time frame
Enrollment to end of follow up, up to 24 months4
Change in patient-reported cognitive function
Evaluation of cognitive function changes reported by patients, measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4a. This form contains 4 items. Each item is scored on a Likert scale from 1 (Never) to 5 (Very often). Raw scores are converted to T-scores using a scoring table. Higher T-scores indicate better cognitive function.
Time frame
Enrollment to end of follow up, up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov