EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
Summary
This phase II trial tests how well an exercise intervention, Exercising Together, works in preventing declines in physical and mental health in couples during radiation treatment for cancer. Treatments for cancer can cause side effects such as fatigue as well as strain on relationships. Exercising Together is a partnered exercise program that adds communication, collaboration and support between partners during exercise to fortify the relationship and amplify the benefits of physical training. Exercising Together program may be effective on the mental and physical health of couples during radiation treatment for cancer.
Detailed description
PRIMARY OBJECTIVE: I. To test the effectiveness and mechanisms of the adapted Exercise Together intervention on mental and physical health of couples (Aims 1 \& 2). SECONDARY OBJECTIVE: I. To gain better understanding of the implementation context and implementation outcomes (Aim 3). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial. ARM II: Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial.
Arms & interventions
- OtherExercise Intervention
Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- OtherEducational Intervention
Receive educational materials
Outcome measures
Primary
Physical functioning
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual pace gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Time frame: Baseline, Months 2, Month 4, and Month 6
Anxiety
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Secondary
Changes in patient-reported symptoms
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sexual function and satisfaction
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sleep Behavior: total sleep time
Time frame: Baseline, Months 2, Month 4, and Month 6
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Months 2, and Month 6
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239