EMBRACE: Exercising Together

OHSU Knight Cancer Institute

Status and phase: Enrolling; Phase 2

Conditions: Prostate Carcinoma; Breast Carcinoma

Treatments: Other: Educational Intervention; Procedure: Biospecimen Collection; Other: Exercise Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06049355

R01CA277738-01 (U.S. NIH Grant/Contract)

STUDY00025294

NCI-2023-02279 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Arm I (Exercise Together exercise program)

Experimental group

Description:

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.

Treatment:

Other: Exercise Intervention

Procedure: Biospecimen Collection

Arm II (educational material)

Active Comparator group

Description:

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

Treatment:

Procedure: Biospecimen Collection

Other: Educational Intervention