Partnered exercise program for couples during cancer treatment
Official title: EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
Run by OHSU Knight Cancer Institute · NCT06049355 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | April 18, 2024 |
| Main results expected | June 30, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06049355 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include couples where one partner has histologically confirmed breast or prostate cancer and is scheduled for radiation therapy.
✕Probably not a fit
Patients with metastatic disease or those not undergoing radiation therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown positive outcomes with exercise interventions for cancer patients, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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)
• Completed surgery \>= 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer or hormone therapy for breast cancer
* Confirmed by self-report on the Health History Questionnaire (HHQ). If unknown, the participant's healthcare 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 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.
• Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
* Confirmed by staff interaction and/or the professional opinion of the Principal Investigators, Dr. Kerri Winters-Stone
Where it's running
-
OHSU Knight Cancer Institute
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Kerri Winters-Stone — OHSU Knight Cancer Institute
- Study coordinator: Carolyn Guidarelli
- Email: exercise@ohsu.edu
- Phone: 503-494-0444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.