OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
Location status: Recruiting
Location contact
Carolyn Guidarelli
CONTACT
Kerri Winters-Stone
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06049355
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Portland, Oregon, 97239, United States
Location status: Recruiting
Carolyn Guidarelli
CONTACT
Kerri Winters-Stone
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo Exercise Together exercise program, a supervised group exercise program delivered online, using a live remote format
Undergo collection of blood samples
Other names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Receive educational materials
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
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.
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).
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
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.
Time frame: Baseline, Month 1, Month 2, Month 4, and Month 6
Assessed with a 14-item measure in the past 30 days and is specific to either male or female
Time frame: Baseline, Months 2, Month 4, and Month 6
Measured using ActiGraph Link, we will have extended wear time to measures total sleep time over a 3-day monitoring period.
Time frame: Baseline, Months 2, and Month 6
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.
Contact information is provided by the study sponsor or research team.
OHSU Knight Cancer Institute
Other
EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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