EMBRACE: Exercising Together

Study Overview
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Brief Summary
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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
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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.

Official Title
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EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER

Conditions
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Breast Carcinoma, Prostate Carcinoma

Intervention / Treatment
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* Other: Exercise Intervention
* Procedure: Biospecimen Collection
* Other: Educational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: INTERVENTION (SURVIVORS) INCLUSION Histologically confirmed prostate cancer or breast cancer without evidence of metastatic disease Confirmed by review of the electronic medical record (EMR) and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their Oregon Health & Science University (OHSU) provider will be contacted for confirmation Scheduled to receive radiation therapy for curative intent at OHSU Confirmed by review of the EMR and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their OHSU provider will be contacted for confirmation Co-residing with an intimate partner or spouse who is willing to participate Confirmed by self-report on the Demographic Questionnaire INTERVENTION (SURVIVORS AND PARTNERS) INCLUSION 18 years of age and older For survivors: confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a case report form (CRF) For partners: confirmed by self-report on the Health History Questionnaire < 2 structured strength training sessions per week in the last month Confirmed by self-report on Health History Questionnaire Home internet sufficient for videoconferencing Confirmed by staff review of Internet Connectivity Screening Guide with the participants and outcome recorded in a CRF Signed informed consent Confirmed by completion of e-Consent in REDCap IMPLEMENTATION INCLUSION Be one of these key stakeholders: patient, spouse/partner, healthcare providers, or administrator Verbal informed consent following review of an Information Sheet Exclusion Criteria: INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent Confirmed by mini-mental state exam (score < 21) or professional opinion of the principal investigator, Kerri Winters-Stone A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate without an assistive device, inability to stand for 3 minutes, severe hearing or vision problem Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by physician clearance. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (Exercise Together exercise program)<br>Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial. | Other: Exercise Intervention<br>* Undergo Exercise Together exercise program<br>Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>* Other names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection;|
| Active Comparator: Arm II (educational material)<br>Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>* Other names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection;Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months | 
| 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). | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months | 
| 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. | Up to 6 months | 
| 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. | Up to 6 months |