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Couple's Exercise for Cancer

N/A
Waitlist Available
Led By Kerri Winters-Stone
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6 and 12 months
Awards & highlights

Study Summary

This trial is comparing the benefits of exercising together as a couple versus exercising separately. Data will be collected at various intervals to measure the effects of the different exercise routines.

Who is the study for?
This trial is for couples where one partner has been diagnosed with breast, prostate, or colorectal cancer within the last three years and has finished treatment at least six weeks ago. They must be living together, not very active in strength training, and able to attend most exercise classes. Those with certain medical conditions or cognitive issues that affect exercise ability or class attendance are excluded.Check my eligibility
What is being tested?
The study tests a 'couples' exercise program against two other approaches: one where partners work out separately in a group setting and another where they exercise independently at home. All participants will engage in their assigned exercise routines for six months and have follow-ups until twelve months.See study design
What are the potential side effects?
Since this trial involves moderate intensity physical activity, potential side effects may include muscle soreness, fatigue, joint pain or injury risk associated with any new workout routine. However, these are generally mild and can decrease over time as fitness improves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concealment of symptoms
Dyadic coping
Emotional intimacy
+4 more
Secondary outcome measures
Anxiety: PROMIS anxiety short form
Body composition
Cardiovascular health: insulin resistance
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III (unsupervised exercise separately)Experimental Treatment3 Interventions
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD.
Group II: Arm II (supervised exercise separately)Experimental Treatment2 Interventions
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Group III: Arm I (supervised exercise together)Experimental Treatment2 Interventions
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,927,985 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
975 Previous Clinical Trials
7,385,678 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,192 Total Patients Enrolled

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03630354 — N/A
Cancer Research Study Groups: Arm III (unsupervised exercise separately), Arm II (supervised exercise separately), Arm I (supervised exercise together)
Cancer Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT03630354 — N/A
Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03630354 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass participants that are younger than forty?

"This trial has a 35 to 80 year old age demarcation point, meaning that anyone outside this range is ineligible. There are 247 clinical trials specifically for youngsters and 6622 options available for seniors."

Answered by AI

What are the chief goals of this research endeavor?

"This clinical trial will take place over a period of 12 months, with observations at Baseline, 3 Months, 6 Months and 12 Months. The primary objective is to analyse the level of Fatigue incongruence among participants. Secondary outcomes that our team intends to measure include Cardiovascular health: Insulin resistance (HOMA-IR), Fear of recurrence and Anxiety levels (PROMIS anxiety short form). All data collection will be conducted using 1 - 5 rating scales."

Answered by AI

Are there still opportunities available for individuals to join this research project?

"As evinced by the data on clinicaltrials.gov, this medical study is no longer recruiting patients having been last updated in late November of 2022. Despite that, there are presently 6748 other trials actively seeking participants for their research."

Answered by AI

To whom is enrollment into this experiment available?

"This medical trial has recruited 534 individuals aged between 35 and 80 with a diagnosis of prostate, bladder or colorectal cancer within the last three years. Additionally, these participants must have completed treatment (such as radiation therapy) at least six weeks prior to enrollment; concurrent hormone replacement is also allowed. The study also involves an intimate partner or spouse who is willing to take part in the research. Finally, potential patients should demonstrate low levels of physical activity (< 2 strength training sessions per week)."

Answered by AI
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~85 spots leftby May 2025