Breast CarcinomaPhase 2NCT06049355
EMBRACE: Exercising Together
A Phase 2 study testing Exercise Intervention, Biospecimen Collection and Educational Intervention in people with Breast Carcinoma and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Prostate Carcinoma
- What is being tested?
- Exercise Intervention, Biospecimen Collection and Educational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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. 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)
- Completed surgery >= 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer or hormone therapy for breast cancer
Show all 24Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Carolyn Guidarelli, 503-494-0444, exercise@ohsu.edu
Kerri Winters-Stone
About this study
Official title: EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To test the effectiveness and mechanisms of the adapted Exercise Together intervention on mental and physical health of couples (Aims 1 \& 2).
SECONDARY OBJECTIVE:
- To gain better understanding of the implementation context and implementation outcomes (Aim 3).
ADMINISTRATIVE SUPPLEMENT AIMS:
- To develop and apply novel computational models that analyze the joint effects of three or more temporally co-occurring modifiable risk factors on cancer outcomes.
II. Adequate access to temporal data at the individual level for each risk factor by using 24-hour actigraphy data collected on cancer dyads participating in the parent trial.
III. Applying a structural equation modeling approach to examine congruence of co-occurring movement behaviors within and between cancer dyads participating in behavioral intervention trial to improve dyadic cancer outcomes.
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.
- Conditions
- Breast Carcinoma, Prostate Carcinoma
- Being tested
- Exercise Intervention, Biospecimen Collection, Educational Intervention
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo collection of blood samples
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Exercise Together exercise program) | Experimental | 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. Receives: Other: Exercise Intervention; Procedure: Biospecimen Collection |
| Arm II (educational material) | Active comparator | Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples using self collection methods throughout the trial. Receives: Procedure: Biospecimen Collection; Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual pace gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Measured: Baseline, Months 2, Month 4, and Month 6
Anxiety
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
Measured: Baseline, Month 1, Month 2, Month 4, and Month 6
Secondary outcomes (6)
Changes in patient-reported symptoms: fatigue
Measured by PROMIS FACIT-Fatigue to assess how tired, weak, or limited a person feels due to fatigue. Will use the 13-item measure for symptoms in the past 7 days using questions on a scale ranging from 1 (not at all) to 5 (very much).
Measured: Baseline, Month 1, Month 2, Month 4, and Month 6
Changes in patient-reported symptoms: mental health
Measured by PROMIS to assess symptoms of mental health such as sadness, worthlessness, and hopelessness. Will use the 8-item measures for symptoms in the past 7 days using questions on a scale ranging from 1 (never) to 5 (always).
Measured: Baseline, Month 1, Month 2, Month 4, and Month 6]
Changes in patient-reported symptoms: global health
Measured by PROMIS to assess symptoms of global health (QoL). Global health is assessed with a 10-item measure that asks about physical, mental and social functioning using questions on a scale ranging from 1 (poor/not at all/always/sever) to 5 (excellent/completely/never/none) and a 0 (no pain) to 10 (worst imaginable pain) scale.
Measured: Baseline, Month 1, Month 2, Month 4, and Month 6
Sexual function and satisfaction
Assessed with a 14-item measure in the past 30 days and is specific to either male or female
Measured: Baseline, Month 1, Month 2, Month 4, and Month 6
Sleep Behavior: total sleep time
Measured using ActiGraph Link, we will have extended wear time to measures total sleep time over a 3-day monitoring period.
Measured: Baseline, Months 2, Month 4, and Month 6
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Measured using a self-administered dried blood spot (DBS) collection kit. Participants are taught by research staff and follow a YouTube video to use a finger stick poke to obtain a drop of blood that is put onto a sample card. DBS captured on the designated card are dried thoroughly (> 4 hours at room temperature), then inserted into a foil pouch with desiccant and mailed to the research team. Cards are frozen (0 degree Fahrenheit [F] or below) until analyzed.
Measured: Baseline, Months 2, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start18 Apr 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049355
- Sponsor's protocol ID
- STUDY00025294
- Other IDs
- NCI-2023-02279, R01CA277738-01
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual quantitative participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
- ClinicalTrials.gov ID
- NCT06049355
- Acronym / sponsor ID
- STUDY00025294
- Conditions
- Breast Carcinoma, Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Cancer Institute (NCI)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To test the effectiveness and mechanisms of the adapted Exercise Together intervention on mental and physical health of couples (Aims 1 \& 2).
SECONDARY OBJECTIVE:
- To gain better understanding of the implementation context and implementation outcomes (Aim 3).
ADMINISTRATIVE SUPPLEMENT AIMS:
- To develop and apply novel computational models that analyze the joint effects of three or more temporally co-occurring modifiable risk factors on cancer outcomes.
II. Adequate access to temporal data at the individual level for each risk factor by using 24-hour actigraphy data collected on cancer dyads participating in the parent trial.
III. Applying a structural equation modeling approach to examine congruence of co-occurring movement behaviors within and between cancer dyads participating in behavioral intervention trial to improve dyadic cancer outcomes.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Exercise Together exercise program) | Experimental | Other: Exercise Intervention, Procedure: Biospecimen CollectionPatients 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. |
| Arm II (educational material) | Active comparator | Procedure: Biospecimen Collection, Other: Educational InterventionPatients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples using self collection methods throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- INTERVENTION (SURVIVORS) INCLUSION
- Scheduled to receive radiation therapy for curative intent
- Co-residing with an intimate partner or spouse who is willing to participate
- INTERVENTION (SURVIVORS AND PARTNERS) INCLUSION
- 18 years of age and older
Key exclusion criteria (7 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionUndergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format | Other | Arm I (Exercise Together exercise program) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm I (Exercise Together exercise program), Arm II (educational material) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials | Other | Arm II (educational material) |
Primary outcome
Physical functioning
Time frame: Baseline, Months 2, Month 4, and Month 6
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual pace gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Anxiety
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
6 secondary outcomes
Changes in patient-reported symptoms: fatigue
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Changes in patient-reported symptoms: mental health
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6]
Changes in patient-reported symptoms: global health
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sexual function and satisfaction
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Sleep Behavior: total sleep time
Time frame: Baseline, Months 2, Month 4, and Month 6
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Months 2, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. All individual quantitative participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri Winters-Stone principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise Intervention, Biospecimen Collection and Educational Intervention in people with Breast Carcinoma and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Guidarelli (503-494-0444, exercise@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning (time frame: Baseline, Months 2, Month 4, and Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.