Clinical trial NCT03630354: EXERCISING TOGETHER for Couples Coping With Cancer
Official title: EXERCISING TOGETHER © for Couples Coping With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Carcinoma
Colorectal Carcinoma
Malignant Solid Neoplasm
Prostate Carcinoma
Stage I Colorectal Cancer AJCC v8
Stage I Prostate Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2018-08-14
Enrollment: 534
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 partners 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.

Detailed description: PRIMARY OBJECTIVES:

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

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/partner.

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

EXPLORATORY OBJECTIVE:

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.

ARM I: Exercising Together Program: Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting.

ARM II: Exercising Together Program: Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting

ARM III: Survivors and partners undergo 2 training sessions over 1 hour with an exercise trainer and then perform exercise routines over 1 hour 2 days per week separately unsupervised at home or a facility following an instructional digital video disc (DVD).

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.

Eligibility criteria: Inclusion Criteria:

* SURVIVORS ONLY:
* Histologically confirmed PC, BC or CRC without evidence of metastatic disease (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician)
* Three years or less from diagnosis date, by month and year, at time of enrollment (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician)
* Completed treatment (e.g., surgery, radiation and/or chemotherapy) \>= 6 weeks prior to enrollment. Concurrent adjuvant hormone therapy is permitted and must have been initiated \>= 6 weeks prior to enrollment. For prostate cancer, androgen deprivation therapy (ADT) may constitute primary treatment and must have been initiated \>= 6 weeks prior to enrollment. For breast cancer, hormone therapy may constitute primary treatment and must have been initiated \>= 6 weeks prior to enrollment. (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician)
* Co-residing with an intimate partner or spouse who is willing to participate (confirmed by self-report on Health History Questionnaire)
* SURVIVORS AND SPOUSES/PARTNERS:
* Underactive (\< 2 strength training sessions per week, lasting 30 minutes or more per session, at a moderate intensity in the last month) (confirmed by self-report on Health History Questionnaire or by discretion of the principal investigator)

Exclusion Criteria:

* SURVIVORS AND SPOUSES/PARTNERS
* Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the principal investigator, Dr. 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: declared pregnancy, 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 (use of an assistive device permitted), inability to stand for 3 minutes, severe hearing or vision problem. (For Survivor: Confirmed by physician clearance; For Spouse/Partner: must answer 'No' to American College of Sports Medicine pre-participation screening questions. If spouse/partner answers 'Yes' to either question they will be considered eligible upon physician clearance. Physician clearance may also be requested at the discretion of the principal investigator. For either: absence of pregnancy in persons who could possibly be pregnant but have not declared a pregnancy at screening, will be further screened with a pregnancy test administered at each testing visit.)
* Knowingly unable to attend \> 75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_Exercising Together")
* Not fluent in English and therefore incapable of answering survey questions, participating in class, following directions during performance testing, and providing informed consent when English is the language used. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_Exercising Together" or the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone.)

Primary outcomes:
measure: Dyadic coping
timeFrame: Baseline (just prior to randomization), 3, 6 and 12 months
measure: Emotional intimacy
timeFrame: Baseline, 3, 6 and 12 months
measure: Physical intimacy
timeFrame: Baseline, 3, 6 and 12 months
measure: Concealment of symptoms
timeFrame: Baseline, 3, 6 and 12 months
measure: Pain incongruence
timeFrame: Baseline, 3, 6 and 12 months
measure: Fatigue incongruence
timeFrame: Baseline, 3, 6 and 12 months
measure: Perceived physical function incongruence
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Body composition
timeFrame: Baseline, 3, 6 and 12 months
measure: Cardiovascular health: serum fasting lipids
timeFrame: Baseline, 3, 6 and 12 months
measure: Cardiovascular health: insulin resistance
timeFrame: Baseline, 3, 6 and 12 months
measure: Cardiovascular health: resting blood pressure
timeFrame: Baseline, 3, 6 and 12 months
measure: Inflammation-hsCRP
timeFrame: Baseline, 3, 6 and 12 months
measure: Inflammation-TNF alpha
timeFrame: Baseline, 3, 6 and 12 months
measure: Objective physical function
timeFrame: Baseline, 3, 6 and 12 months
measure: Quality of life (QOL): QLQ-C30
timeFrame: Baseline, 3, 6 and 12 months
measure: Quality of life (QOL): SF-36
timeFrame: Baseline, 3, 6 and 12 months
measure: Depressive symptoms: CES-D
timeFrame: Baseline, 3, 6 and 12 months
measure: Anxiety: PROMIS anxiety short form
timeFrame: Baseline, 3, 6 and 12 months
measure: Fear of recurrence
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters-Stone KM, Boisvert C, Li F, Lyons KS, Beer TM, Mitri Z, Meyers G, Eckstrom E, Campbell KL. Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise? Support Care Cancer. 2022 Mar;30(3):1903-1906. doi: 10.1007/s00520-021-06669-w. Epub 2021 Nov 6.
citation: Winters-Stone KM, Lyons KS, Dieckmann NF, Lee CS, Mitri Z, Beer TM. Study protocol for the Exercising Together(c) trial: a randomized, controlled trial of partnered exercise for couples coping with cancer. Trials. 2021 Aug 30;22(1):579. doi: 10.1186/s13063-021-05548-3.