RecruitingPhase 2

EMBRACE: Exercising Together

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo collection of blood samples throughout the trial."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Exercising Together helps couples keep their physical and mental health during cancer radiation treatment. The program uses partner exercises, communication, and teamwork. It is for people with breast or prostate cancer and their live-in partners.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The person with cancer must have breast or prostate cancer confirmed by a tissue test, with no signs it has spread to distant parts of the body.
  • The person with cancer must be scheduled for radiation treatment meant to cure the cancer.
  • Surgery must have been completed at least 6 weeks before joining. No other added cancer treatment is allowed except hormone treatment for breast or prostate cancer.
  • The person with cancer must live with a spouse or intimate partner who is willing to join.
  • Both partners must be at least 18 years old.
  • Both partners must report fewer than 2 planned strength-training sessions, lasting less than 30 minutes per week, during the past month.
  • Both partners must have home internet that supports video calls, sign a consent form, accept assignment by chance to either study group, and follow study rules.
  • For the part about putting the program into use, participants must be a patient, spouse or partner, healthcare provider, or administrator. They must give spoken consent after receiving an information sheet.

Who can't join

  • Either partner has thinking or memory problems that prevent answering surveys, doing exercises or tests, or giving consent.
  • Either partner has a health condition or takes medicine that makes moderate exercise unsafe. Examples include poorly controlled diabetes, a recent heart problem, nerve or muscle disease, or untreated high blood pressure when standing.
  • Other unsafe conditions include recent surgery, a new or active hernia, or active rheumatoid arthritis, a disease that causes painful, swollen joints.
  • Either partner has severe memory, balance, hearing, or vision problems; needs a walker or wheelchair to move around; or cannot stand for 3 minutes.
  • Either partner cannot use English well enough to answer surveys, follow exercise or testing directions, and give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official 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) • Completed surgery \>= 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer or hormone therapy for breast cancer * Confirmed by self-report on the Health History Questionnaire (HHQ). If unknown, the participant's healthcare provider will be contacted for confirmation * 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. • Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English * Confirmed by staff interaction and/or the professional opinion of the Principal Investigators, Dr. Kerri Winters-Stone

Study sites (1)

OR