Partnered exercise program for couples during cancer treatment

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

This study tests whether a partnered exercise program can help couples stay healthy during radiation treatment for breast and prostate cancer compared to just receiving exercise information.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OHSU Knight Cancer Institute (other)
• Drugs / interventions: radiation
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06049355 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the effectiveness of the Exercising Together intervention, which is designed to help couples maintain their physical and mental health during radiation treatment for breast and prostate cancer. Participants are randomized into two groups: one group engages in a partnered exercise program while the other receives educational materials about exercise. The study aims to assess both the health outcomes of the couples and the implementation of the exercise program. Blood samples will also be collected throughout the trial to analyze potential biological effects.

Who should consider this trial

Good fit: Ideal candidates include couples where one partner has histologically confirmed breast or prostate cancer and is scheduled for radiation therapy.

Not a fit: Patients with metastatic disease or those not undergoing radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could enhance the physical and mental well-being of couples undergoing cancer treatment.

How similar studies have performed: Other studies have shown positive outcomes with exercise interventions for cancer patients, suggesting potential success for this approach.

Eligibility criteria

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 Survivor Health History. In cases where the EMR isn't clear, their Oregon Health \& Science University (OHSU) provider will be contacted for confirmation. For non-OHSU patients, we'll initially collect their cancer health history by a self-report questionnaire and confirm when we receive the survivor's outside medical record (through a signed Release of Information)
* Scheduled to receive radiation therapy for curative intent

  * Confirmed by review of the EMR and subsequently recorded in Survivor Health History. In cases where the EMR isn't clear, their OHSU provider will be contacted for confirmation/ For non-OHSU patients, we'll initially collect their cancer health history by a self-report questionnaire and confirm when we receive the survivor's outside medical record (through a signed Release of Information)
* 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 Survivor Health History. For non-OHSU patients, we'll collect their age by self-report on the Survivor Health History
  * For partners: confirmed by self-report on the Health History Questionnaire
* \< 2 structured strength training sessions for less than 30 minutes 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
* Willing to be randomized into either study arm and adhere to study protocol

  * Confirmed verbally with the participant and response documented in the Participant Tracking database
* IMPLEMENTATION INCLUSION
* Be one of these key stakeholders: patient, spouse/partner, healthcare providers, or administrator
* Verbal informed consent following receipt 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

  * In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance 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 a walker or wheelchair, 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. For Spouse/Partner: must answer \'No\' to American College of Sports Medicine pre-participation screening questions. If spouse/partner answers \'Yes\' to either question they may be required to obtain physician clearance prior to becoming eligible. Physician clearance may also be requested at the discretion of the principal investigator.

Where this trial is running

Portland, Oregon

• OHSU Knight Cancer Institute — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Kerri Winters-Stone — OHSU Knight Cancer Institute
• Study coordinator: Carolyn Guidarelli

Conditions: Breast Carcinoma, Prostate Carcinoma