EMBRACE: Exercising Together

NCT ID: NCT06049355

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2028-09-01

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To test the effectiveness and mechanisms of the adapted Exercise Together intervention on mental and physical health of couples (Aims 1 & 2).

SECONDARY OBJECTIVE:

I. To gain better understanding of the implementation context and implementation outcomes (Aim 3).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial.

ARM II: Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial.

Conditions

Breast Carcinoma; Prostate Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

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

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

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.

Group Type: ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Educational Intervention

Intervention Type: OTHER

Receive educational materials

Interventions

Exercise Intervention

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

Intervention Type: OTHER

Biospecimen Collection

Undergo collection of blood samples

Intervention Type: PROCEDURE

Educational Intervention

Receive educational materials

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection; Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kerri Winters

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Winters-Stone

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolyn Guidarelli

Role: CONTACT

exercise@ohsu.edu

503-494-0444

Facility Contacts

Carolyn Guidarelli

Role: primary

exercise@ohsu.edu

503-494-0444

Other Identifiers

NCI-2023-02279

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01CA277738-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00025294

Identifier Type: -

Identifier Source: org_study_id