EXERCISING TOGETHER© for Couples Coping With Cancer



Status:Recruiting
Conditions:Breast Cancer, Prostate Cancer, Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 75
Updated:1/2/2019
Start Date:November 9, 2018
End Date:March 31, 2023

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EXERCISING TOGETHER©: An Intervention for Couple Coping With Prostate, Breast and Colorectal Cancer

The Exercising Together trial is a single-blind, parallel group, randomized controlled trial
comparing 3 arms: Arm 1 (experimental): Exercising Together where couples perform partnered
exercise in a supervised, group setting versus two comparator conditions where survivors and
spouses perform exercise routines separately in either a supervised group setting (Arm 2) or
unsupervised at home (Arm 3). All three arms will train for a 6-month period and then be
followed 6 months later. Data will be collected at baseline, 3, 6 and 12 months.

PRIMARY OBJECTIVES:

I. Determine the efficacy of Exercising Together on relationship quality (intimacy,
communication and incongruence) in couples coping with prostate, breast, or colorectal
cancer.

II. Determine the efficacy of Exercising Together on the physical health (body composition,
lipids, insulin resistance, blood pressure, inflammation, and physical function) and mental
health (anxiety, depressive symptoms, fear of recurrence) of both the survivor and spouse.

III. Determine how long individual and couple-level benefits from Exercising Together last.

SECONDARY OBJECTIVES:

I. Identify the types of couples that benefit most from Exercising Together.

OUTLINE:

Study is a 3-group, 12-month (6 months of exercise training + 6-months follow-up) randomized
trial of couples comparing a supervised group program of Exercising Together to: 1) separate
supervised group exercise (survivor-only and spouse-only classes) and 2) separate
unsupervised exercise where survivors and spouses exercise on their own at home.

ARM 1: Exercising Together Program: Couples perform partnered exercise in a supervised, group
setting ARM 2: Couples exercising separately in supervised group setting. ARM 3: Unsupervised
exercises at home. All participants will be expected to engage in 1-hr exercise sessions, 2
days a week for 6 months. The basic training program for all three study arms is a functional
strength training program. Participants will use free weights (weighted vest, dumbbells,
elastic bands) while performing lower body (chair rises, squats, lunges, stepups) and upper
body (1-arm row, bench press, push-ups, triceps extension, bicep curls, shoulder raise)
resistance exercise. Volume of resistance exercise, determined by intensity (weight, tailored
to each individual) and duration (number of repetitions and sets), is gradually increased
from low weight and high repetitions to more weight and fewer repetitions over the training
period.

Inclusion Criteria: Survivors Only:

- Histologically confirmed prostate, breast or colon cancer without evidence of
metastatic disease

- Completed primary treatment (surgery, radiation and/or chemotherapy) >3 mos. But < 2
years prior to enrollment. Concurrent adjuvant hormone therapy is permitted. For
prostate cancer, Androgen Deprivation Therapy (ADT) may constitute primary treatment
and must have been initiated within the last 2 years.

- Co-residing with an intimate partner or spouse who is willing to participate

Inclusion Criteria: Survivors and Spouses:

- Age 40-75 years

- Underactive (average <75 minutes per week of moderate intensity aerobic exercise per
week or < 2 strength training sessions per week in the last month)

Exclusion Criteria: Survivors and Spouses:

- 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.
We found this trial at
1
site
3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
Phone: 503-494-0444
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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Portland, OR
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