EMBRACE: Exercising Together

Last updated: January 28, 2025
Sponsor: OHSU Knight Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer

Cancer/tumors

Prostate Cancer, Early, Recurrent

Treatment

Biospecimen Collection

Educational Intervention

Exercise Intervention

Clinical Study ID

NCT06049355
STUDY00025294
R01CA277738-01
NCI-2023-02279
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • INTERVENTION (SURVIVORS) INCLUSION

  • Histologically confirmed prostate cancer or breast cancer without evidence ofmetastatic disease

  • Confirmed by review of the electronic medical record (EMR) and subsequentlyrecorded in Survivor Health History. In cases where the EMR isn't clear, theirOregon Health & Science University (OHSU) provider will be contacted forconfirmation. For non-OHSU patients, we'll initially collect their cancerhealth history by a self-report questionnaire and confirm when we receive thesurvivor'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 HealthHistory. In cases where the EMR isn't clear, their OHSU provider will becontacted for confirmation/ For non-OHSU patients, we'll initially collecttheir cancer health history by a self-report questionnaire and confirm when wereceive the survivor's outside medical record (through a signed Release ofInformation)

  • 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 theElectronic Medical Record (EMR) and subsequently recorded in Survivor HealthHistory. For non-OHSU patients, we'll collect their age by self-report on theSurvivor 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 inthe 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 theparticipants 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 theParticipant Tracking database

  • IMPLEMENTATION INCLUSION

  • Be one of these key stakeholders: patient, spouse/partner, healthcare providers, oradministrator

  • Verbal informed consent following receipt of an Information Sheet

Exclusion

Exclusion Criteria:

  • INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION

  • Cognitive difficulties that preclude answering the survey questions, participatingin the exercise classes or performance tests, or providing informed consent

  • In the event of a suspected undeclared cognitive impairment, it will beconfirmed by physician clearance or professional opinion of the PrincipalInvestigator, Kerri Winters-Stone

  • A medical condition, movement or neurological disorder, or medication use thatcontraindicates participation in moderate intensity exercise. Specificcontraindications include the following: poorly controlled diabetes, recent cardiacevent, neuromuscular disease, untreated orthostatic hypertension, recent surgery,acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balancedisorder, inability to ambulate without a walker or wheelchair, inability to standfor 3 minutes, severe hearing or vision problem

  • Confirmed by a combination of reviewing the EMR, self-report on the HealthHistory Questionnaire, Charlson Comorbidity Index questionnaire, and/or byphysician clearance. If in the professional opinion of the PrincipalInvestigator, Dr. Kerri Winters-Stone, contraindications other than thoseidentified by the patient or physician are present, she may consider theparticipant ineligible. For Spouse/Partner: must answer 'No' toAmerican College of Sports Medicine pre-participation screening questions. Ifspouse/partner answers 'Yes' to either question they will be consideredeligible upon physician clearance. Physician clearance may also be requested atthe discretion of the principal investigator.

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Biospecimen Collection
Phase: 2
Study Start date:
April 18, 2024
Estimated Completion Date:
September 01, 2028

Study 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.

Connect with a study center

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.