Clinical trial NCT06049355: EMBRACE: Exercising Together
Official title: EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Carcinoma
Prostate Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Cancer Institute (NCI)
First posted: 2023-09-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 \&amp; 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
* \&lt; 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 \&#39;No\&#39; to American College of Sports Medicine pre-participation screening questions. If spouse/partner answers \&#39;Yes\&#39; 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.

Primary outcomes:
measure: Physical functioning
timeFrame: Baseline, Months 2, Month 4, and Month 6
measure: Anxiety
timeFrame: Baseline, Month 1, Month 2, Month 4, and Month 6
Secondary outcomes:
measure: Changes in patient-reported symptoms
timeFrame: Baseline, Month 1, Month 2, Month 4, and Month 6
measure: Sexual function and satisfaction
timeFrame: Baseline, Month 1, Month 2, Month 4, and Month 6
measure: Sleep Behavior: total sleep time
timeFrame: Baseline, Months 2, Month 4, and Month 6
measure: Inflammation - high sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Months 2, and Month 6
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References: