Recruiting

Phase 2

Observational StudyEMBRACE: Exercising Together

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06049355

Conditions

Breast Carcinoma

Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exercise Intervention

Biospecimen Collection

Educational Intervention

Study Details

Brief 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.

Conditions

Breast Carcinoma

Prostate Carcinoma

Study ID

NCT06049355

Start date

Apr 18, 2024

Status verified date

Jan, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (Exercise Together exercise program)

Patients and partners undergo Exercising Together supervised group exercise program using live remote video conference technology over 75 minutes three times a week (TIW) for 8 weeks during radiation therapy on study. Patients also undergo collection of blood samples using self-collection methods throughout the trial.

active comparator: Arm II (educational material)

Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples using self collection methods throughout the trial.

Interventions

Exercise Intervention

Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format

Biospecimen Collection

Undergo collection of blood samples

Educational Intervention

Receive educational materials

Primary outcome measure

Physical functioning [ Time Frame: Baseline, Months 2, Month 4, and Month 6 ]
Anxiety [ Time Frame: Baseline, Month 1, Month 2, Month 4, and Month 6 ]

Central Contacts and Locations

Central contacts

Carolyn Guidarelli

503-494-0444 exercise@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Carolyn Guidarelli

503-494-0444 exercise@ohsu.edu

Principal Investigator:

Kerri Winters-Stone

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

May 29, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2025-05-29.