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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Contact Information
Primary
Carolyn Guidarelli
exercise@ohsu.edu
503-494-0444
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials