EMBRACE: Exercising Together
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Intervention
Other interventionUndergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Educational Intervention
Other interventionReceive educational materials
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Arm I (Exercise Together exercise program)Experimental treatment 2 interventions
Group B: Arm II (educational material)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Months 2, Month 4, and Month 62
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).
Time frame
Baseline, Month 1, Month 2, Month 4, and Month 6Secondary outcomes
1
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).
Time frame
Baseline, Month 1, Month 2, Month 4, and Month 62
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).
Time frame
Baseline, Month 1, Month 2, Month 4, and Month 6]3
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.
Time frame
Baseline, Month 1, Month 2, Month 4, and Month 64
Sexual function and satisfaction
Assessed with a 14-item measure in the past 30 days and is specific to either male or female
Time frame
Baseline, Month 1, Month 2, Month 4, and Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov