Exercising Together for Breast and Prostate Cancer

This study, called EMBRACE: Exercising Together, is testing a group exercise program for couples where one partner has breast or prostate cancer and is undergoing radiation treatment. The program, delivered online, aims to help prevent declines in physical and mental health that can happen during cancer treatment. It focuses on communication and support between partners during exercise. Researchers will measure your physical functioning and anxiety levels at different times over six months to see if the program is effective. This study is looking for 400 participants and is currently recruiting.

Study design
This study is interventional and will involve about 400 participants. You will be randomly assigned to either the Exercising Together program or to receive educational materials about exercise.
What's involved
If you join, you will participate in the Exercising Together program or receive educational materials. You will also have blood samples collected throughout the trial, and your physical functioning and anxiety will be measured at specific times over six months.
Compensation
Not stated in the trial record.
Follow-up
Your physical functioning will be measured up to 6 months, and anxiety will be measured up to 6 months after starting the study.

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NCT06049355

EMBRACE: Exercising Together

Recruiting
PHASE2Ages 18+InterventionalSupportive care
OHSU Knight Cancer Institute
~400 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:Exercise InterventionBiospecimen CollectionEducational Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Physical functioning
Measured over Baseline, Months 2, Month 4, and Month 6
+1 more outcome measured
Breast Carcinoma
Prostate Carcinoma
1 sites across 1 states
Oregon1
  • Kerri Winters-Stone · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Physical functioningBaseline, Months 2, Month 4, and Month 6

    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.

  • AnxietyBaseline, Month 1, Month 2, Month 4, and Month 6

    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).