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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
400
Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format
Undergo collection of blood samples
Receive educational materials
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGPhysical 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
Changes in patient-reported symptoms
Measured by PROMIS to assess symptoms of physical and mental health and global health (QoL). We will use the 13-item measure and 8-item measures for symptoms in the past 7 days. Global health is assessed with a 10-item measure that asks about physical, mental and social functioning.
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sexual function and satisfaction
Assessed with a 14-item measure in the past 30 days and is specific to either male or female
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sleep Behavior: total sleep time
Measured using ActiGraph Link, we will have extended wear time to measures total sleep time over a 3-day monitoring period.
Time frame: Baseline, Months 2, Month 4, and Month 6
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Measured using a self-administered dried blood spot (DBS) collection kit. Participants are taught by research staff and follow a YouTube video to use a finger stick poke to obtain a drop of blood that is put onto a sample card. DBS captured on the designated card are dried thoroughly (\> 4 hours at room temperature), then inserted into a foil pouch with desiccant and mailed to the research team. Cards are frozen (0 degree Fahrenheit \[F\] or below) until analyzed.
Time frame: Baseline, Months 2, and Month 6
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