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NCT06049355RecruitingPhase 2

EMBRACE: Exercising Together

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
400 (estimated)
First submitted
11 Sept 2023
Start date
18 Apr 2024
Primary completion date
30 Jun 2028
Lead sponsor
OHSU Knight Cancer Institute
NCT number
NCT06049355

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 400
  • From 18 Apr 2024 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Other

  • INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OHSU Knight Cancer Institute
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.