Clinical trial for Breast Carcinoma
Official title EMBRACE: Exercising Together
ClinicalTrials.gov ID: NCT06049355
What this study is testing
- What it's testing
- This study aims to find out if exercising together with communication support prevents physical and mental health declines in couples receiving radiation.
- Who it's for
- Couples where one partner is receiving radiation treatment for breast or prostate cancer.
- What's involved
- Participants will join a partnered exercise program that includes physical training and activities to improve communication and support between partners.
- Time commitment
- The study lasts for the duration of the radiation treatment period, requiring regular participation in the exercise sessions.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- Scheduled to receive radiation therapy for curative intent
- Confirmed by review of the EMR and subsequently recorded in Survivor Health History.
You likely can't join if
- INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION
- Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing...
- In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance or professional opinion of the Principal...
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise.
- Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by...
- Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing...
See the full eligibility criteria
Who can join
- 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.
- 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...
- 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 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 assigned by chance 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
What rules you out
- 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.
- Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by physician clearance.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.