Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02279 | Registry Identifier | CTRP (Clinical Trial Registration Program) | |
| R01CA277738-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Baseline, Month 1, Month 2, Month 4, and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patient-reported symptoms | Measured by PROMIS to assess symptoms of physical and mental health and global health (QoL). We will use the 13-item measure and 8-item measures for symptoms in the past 7 days. Global health is assessed with a 10-item measure that asks about physical, mental and social functioning. | Baseline, Month 1, Month 2, Month 4, and Month 6 |
Not provided
Inclusion Criteria:
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
< 2 structured strength training sessions for less than 30 minutes per week in the last month
Home internet sufficient for videoconferencing
Signed informed consent
Willing to be randomized into either study arm and adhere to study protocol
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Guidarelli | Contact | 503-494-0444 | exercise@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kerri Winters-Stone | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
All individual quantitative participant data collected during the trial, after deidentification.
Not provided
Beginning 3 months following final publication.
Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
|
| Educational Intervention | Other | Receive educational materials |
|
|
| Sexual function and satisfaction | Assessed with a 14-item measure in the past 30 days and is specific to either male or female | 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. | 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. | Baseline, Months 2, and Month 6 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |