EXERCISING TOGETHER for Couples Coping With Cancer

NCT03630354 | Completed Results

• 3 other identifiers: STUDY00018000NCI-2018-01404R01CA218093
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• Dyadic Coping - Active Engagement

  Measured by the Active Engagement subscale from the Relationship Focused Coping Scale. The subscale assesses the degree with which couples practice active engagement by responding to five items on a Likert scale from 1 (never) to 5 (very often). Scores range from 5 to 25, with higher scores indicating more active engagement. Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Dyadic Coping - Protective Buffering

  Measured by the Protective Buffering Subscale from the Relationship Focused Coping Scale. Assesses the degree with which couples practice protective buffering by responding to six items using a Likert scale of 1 (never) to 5 (very often). Scores range from 6 to 30 with higher scores indicating more protective buffering. Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6, and 12 months

• Emotional Intimacy

  Measured by the 7-item Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering 7 questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree). Scores range from 0-21 with higher scores indicating better dyadic adjustment. Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Physical Intimacy - Engagement in Sex

  Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in sexual behaviors answering two questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 2 to 8 with higher scores indicating higher physical intimacy.

  Baseline, 3, 6 and 12 months

• Physical Intimacy - Engagement in Affectionate Behaviors

  Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in affectionate behaviors answering four questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 4 to 16 with higher scores indicating higher physical intimacy.

  Baseline, 3, 6, and 12-months

• Concealment of Symptoms

  Measured by the Emotional-Intimacy Disruptive Behavior Scale. Patients report the extent to which they engage in 8 behaviors using a scale from 1 (rarely or none of the time) to 4 (most or all of the time). Scores range from 8-32 where higher scores indicate more concealment Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Pain Incongruence - Pain Intensity

  Measured by the degree of agreement (change or difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate "no pain" and high values represent "pain as bad as you can imagine". Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Pain Incongruence - Pain Interference

  Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate "no pain" and high values represent "pain as bad as you can imagine". Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Fatigue Incongruence

  Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's fatigue in the past 7 days using the Functional Assessment in Chronic Illness Therapy (FACIT) fatigue questionnaire. This instrument has 13 items, and possible scores from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue. Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

• Perceived Physical Function Incongruence

  Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's physical function in the past 4 weeks using the perceived physical function subscale of the SF-36 medical outcomes survey. Possible scores range from 0-100. Low scores indicate a high degree of limitation in performing physical activities, whereas high scores represent no limitations in performing physical activities due to health. Reported values reflect the estimated slope over 6-months.

  Baseline, 3, 6 and 12 months

Secondary Outcomes (16)

• Body Composition - Bone-free Lean Mass

  Baseline, 3, 6 and 12 months

• Body Composition - Fat Mass

  Baseline, 3, 6, and 12 months

• Cardiovascular Health: Serum Cholesterol

  Baseline, 3, 6 and 12 months

• Cardiovascular Health: Serum Triglycerides

  Baseline, 3, 6, and 12 months

• Cardiovascular Health: Insulin Resistance

  Baseline, 3, 6 and 12 months

Study Arms (3)

Arm I (supervised exercise together)

EXPERIMENTAL

Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.

Behavioral: Exercise Intervention (supervised); Other: Questionnaire Administration

Arm II (supervised exercise separately)

EXPERIMENTAL

Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.

Behavioral: Exercise Intervention (supervised); Other: Questionnaire Administration

Arm III (unsupervised exercise separately)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention (unsupervised); Other: Informational Intervention; Other: Questionnaire Administration

Interventions

Exercise Intervention (supervised) BEHAVIORAL

Complete supervised exercise

Arm I (supervised exercise together); Arm II (supervised exercise separately)

Exercise Intervention (unsupervised) BEHAVIORAL

Complete unsupervised exercise

Arm III (unsupervised exercise separately)

Informational Intervention OTHER

Receive instructional DVD

Arm III (unsupervised exercise separately)

Questionnaire Administration OTHER

Ancillary studies

Arm I (supervised exercise together); Arm II (supervised exercise separately); Arm III (unsupervised exercise separately)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• Skiba MB, Dieckmann NF, Lyons KS, Winters-Stone KM. Associations between perceptions of relationship quality and markers of inflammation and insulin resistance among couples coping with cancer. J Cancer Surviv. 2023 Aug;17(4):957-966. doi: 10.1007/s11764-022-01299-5. Epub 2022 Nov 26.

  PMID: 36435952 DERIVED

• 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.

  PMID: 34741653 DERIVED

• 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.

  PMID: 34461975 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This clinical trial enrolled couples (cancer survivors + intimate care partners), thus the information related to participant flow in the trial is reported at the couple level. Outcomes are reported at the level of the individual, thus outcome data are presented for each cancer survivors and care partners over the intervention period (baseline-6 months) and the follow-up period (6 - 12 months).

Results Point of Contact

• Title: Dr. Kerri Winters-Stone
• Organization: Oregon Health & Science University

wintersk@ohsu.edu

503-494-0813

Study Officials

• Kerri Winters-Stone

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 14, 2018
• Study Start: January 18, 2019
• Primary Completion: January 1, 2024
• Study Completion: March 31, 2024
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months following final publication.
• Access Criteria: 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.

Locations

US (1)