RECRUITING

EMBRACE: Exercising Together

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-18

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06049355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 an assistive device, 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 will be considered eligible upon physician clearance. Physician clearance may also be requested at the discretion of the Principal Investigator

Inclusion Criteria

Exclusion 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

* 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 an assistive device, 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 will be considered eligible upon physician clearance. Physician clearance may also be requested at the discretion of the Principal Investigator

Contacts and Locations

Study Contact

Carolyn Guidarelli

CONTACT

503-494-0444

exercise@ohsu.edu

Principal Investigator

Kerri Winters-Stone

PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

Kerri Winters-Stone, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

Breast Carcinoma
Prostate Carcinoma