Anatomic Stage I Breast Cancer AJCC v8NCT03630354

EXERCISING TOGETHER for Couples Coping With Cancer

A study testing Exercise Intervention (supervised), Exercise Intervention (unsupervised) and Informational Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
What is being tested?: Exercise Intervention (supervised), Exercise Intervention (unsupervised) and Informational Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 496 participants
Where: 1 siteUnited States
Study dates: 18 Jan 2019to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: EXERCISING TOGETHER © for Couples Coping With 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 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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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: Survivors and spouses/partners perform exercise routines separately 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.

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
Being tested: Exercise Intervention (supervised), Exercise Intervention (unsupervised), Informational Intervention, Questionnaire Administration
Medical subject headings: Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise Intervention (supervised)Behavioural
Complete supervised exercise
Exercise Intervention (unsupervised)Behavioural
Complete unsupervised exercise
Informational InterventionOther
Receive instructional DVD
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT03630354
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Exercise Intervention (unsupervised); Other: Informational Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6 and 12 months

Secondary outcomes (16)

Body Composition - Bone-free Lean Mass
Measured by bone-free lean (kg) for the whole body determined from a whole body dual energy x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Measured: Baseline, 3, 6 and 12 months
Body Composition - Fat Mass
Measured by fat mas (kg) for the whole body determined from a whole body dual x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Measured: Baseline, 3, 6, and 12 months
Cardiovascular Health: Serum Cholesterol
Measured by serum fasting total cholesterol.
Measured: Baseline, 3, 6 and 12 months
Cardiovascular Health: Serum Triglycerides
Measured by serum triglycerides.
Measured: Baseline, 3, 6, and 12 months
Cardiovascular Health: Insulin Resistance
Measured by Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) - used to assess insulin sensitivity and predict the risk of type 2 diabetes and other metabolic disorders. Calculated as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant, 405. Scores generally range from 0.5 to 2.5, with lower scores indicating better insulin sensitivity and higher scores suggesting higher insulin resistance. A HOMA-IR score of 1.0 or less is considered optimal, while scores above 2.9 may indicate significant insulin resistance. Reported values reflect the estimated slope over 6-months. (Glucose mg/dL * insulin uIU/ml) / 405
Measured: Baseline, 3, 6 and 12 months
Cardiovascular Health: Resting Systolic Blood Pressure
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Measured: Baseline, 3, 6 and 12 months
Cardiovascular Health: Resting Diastolic Blood Pressure
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Measured: Baseline, 3, 6, 12 months
Inflammation-hsCRP
Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.
Measured: Baseline, 3, 6 and 12 months
Inflammation-TNF Alpha
Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.
Measured: Baseline, 3, 6 and 12 months
Objective Physical Function
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 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.
Measured: Baseline, 3, 6 and 12 months
Quality of Life (QOL): QLQ-C30 - Physical Functioning
Measures QOL in cancer patients including subscales of physical functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Measured: Baseline, 3, 6 and 12 months
Quality of Life (QOL): QLQ-C30 - Emotional Functioning
Measures QOL in cancer patients including subscales of emotional functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Measured: Baseline, 3, 6, 12 months
Quality of Life (QOL): SF-36 Physical Function Subscale
The SF-36 measures quality of life using 8 subscales: perceived physical function, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. All subscales have possible scores from 0-100, with items from each subscale averaged together. Low scores indicate worse physical functioning, while higher scores indicate better physical functioning.
Measured: Baseline, 3, 6 and 12 months
Depressive Symptoms: CES-D
Measured by the Center for Epidemiological Studies-Depression (CES-D) scale to determine the degree of depressive symptoms. Scores range from 0-60, with higher scores indicating more symptoms that occur at higher frequencies.
Measured: Baseline, 3, 6 and 12 months
Anxiety: PROMIS Anxiety Short Form
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form 8a, using T score, standardized to mean = 50, SD = 10. Possible range for this short form is 37.1-83.1. Higher T scores reflect higher anxiety. Reported values reflect the estimated slope over 6-months.
Measured: Baseline, 3, 6 and 12 months
Fear of Recurrence
Measured by the Fear of Recurrence scale to assess the amount of concern survivors have about their cancer returning in the future. Participants respond to 22 questions ranging from 1 (strongly agree) to 5 (strongly disagree). The possible range is 22-110. Higher scores reflect higher fear. Reported values reflect the estimated slope over 6-months.
Measured: Baseline, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 201931 Mar 2024

First posted14 Aug 2018
Study start18 Jan 2019
Primary completion1 Jan 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630354
Sponsor's protocol ID: STUDY00018000
Other IDs: NCI-2018-01404, STUDY00018000, R01CA218093
Status last verified: Jun 2025
First submitted: 3 Aug 2018
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All individual quantitative participant data collected during the trial, after deidentification.

Publications

Winters-Stone K, Stoyles SA, Dieckmann N, Sokolova AO, Graff JN, Hung A, Wang S, Lyons KS. Loneliness within couples coping with cancer: prevalence, associations with physical and mental health, and potential benefits of dyadic exercise. Front Aging. 2026 Apr 17;7:1812899. doi: 10.3389/fragi.2026.1812899. eCollection 2026.
PubMed 42077327
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.
PubMed 36435952
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.
PubMed 34741653
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.
PubMed 34461975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EXERCISING TOGETHER © for Couples Coping With Cancer
ClinicalTrials.gov ID: NCT03630354
Acronym / sponsor ID: STUDY00018000
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Oregon Health and Science University
Study start: 18 Jan 2019 (actual)
Primary completion: 1 Jan 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 14 Aug 2018 (actual)
Results: Posted 1 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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).

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

EXPLORATORY OBJECTIVE:

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: Survivors and spouses/partners perform exercise routines separately in a supervised group setting

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Arm I (supervised exercise together)	Experimental	Behavioral: Exercise Intervention (supervised), Other: Questionnaire AdministrationCouples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Arm II (supervised exercise separately)	Experimental	Behavioral: Exercise Intervention (supervised), Other: Questionnaire AdministrationSurvivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Arm III (unsupervised exercise separately)	Experimental	Behavioral: Exercise Intervention (unsupervised), Other: Informational Intervention, Other: Questionnaire AdministrationSurvivors 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.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (5 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise Intervention (supervised)Complete supervised exercise	Behavioural	Arm I (supervised exercise together), Arm II (supervised exercise separately)
Exercise Intervention (unsupervised)Complete unsupervised exercise	Behavioural	Arm III (unsupervised exercise separately)
Informational InterventionReceive instructional DVD	Other	Arm III (unsupervised exercise separately)
Questionnaire AdministrationAncillary studies	Other	Arm I (supervised exercise together), Arm II (supervised exercise separately), Arm III (unsupervised exercise separately)

Primary outcome

Dyadic Coping - Active Engagement
Time frame: Baseline, 3, 6 and 12 months
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.
Dyadic Coping - Protective Buffering
Time frame: Baseline, 3, 6, and 12 months
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.
Emotional Intimacy
Time frame: Baseline, 3, 6 and 12 months
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.
Physical Intimacy - Engagement in Sex
Time frame: Baseline, 3, 6 and 12 months
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.
Physical Intimacy - Engagement in Affectionate Behaviors
Time frame: Baseline, 3, 6, and 12-months
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.
Concealment of Symptoms
Time frame: Baseline, 3, 6 and 12 months
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.
Pain Incongruence - Pain Intensity
Time frame: Baseline, 3, 6 and 12 months
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.
Pain Incongruence - Pain Interference
Time frame: Baseline, 3, 6 and 12 months
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.
Fatigue Incongruence
Time frame: Baseline, 3, 6 and 12 months
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.
Perceived Physical Function Incongruence
Time frame: Baseline, 3, 6 and 12 months
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.

16 secondary outcomes

Body Composition - Bone-free Lean Mass
Time frame: Baseline, 3, 6 and 12 months
Body Composition - Fat Mass
Time frame: Baseline, 3, 6, and 12 months
Cardiovascular Health: Serum Cholesterol
Time frame: Baseline, 3, 6 and 12 months
Cardiovascular Health: Serum Triglycerides
Time frame: Baseline, 3, 6, and 12 months
Cardiovascular Health: Insulin Resistance
Time frame: Baseline, 3, 6 and 12 months
Cardiovascular Health: Resting Systolic Blood Pressure
Time frame: Baseline, 3, 6 and 12 months
Cardiovascular Health: Resting Diastolic Blood Pressure
Time frame: Baseline, 3, 6, 12 months
Inflammation-hsCRP
Time frame: Baseline, 3, 6 and 12 months
Inflammation-TNF Alpha
Time frame: Baseline, 3, 6 and 12 months
Objective Physical Function
Time frame: Baseline, 3, 6 and 12 months
Quality of Life (QOL): QLQ-C30 - Physical Functioning
Time frame: Baseline, 3, 6 and 12 months
Quality of Life (QOL): QLQ-C30 - Emotional Functioning
Time frame: Baseline, 3, 6, 12 months
Quality of Life (QOL): SF-36 Physical Function Subscale
Time frame: Baseline, 3, 6 and 12 months
Depressive Symptoms: CES-D
Time frame: Baseline, 3, 6 and 12 months
Anxiety: PROMIS Anxiety Short Form
Time frame: Baseline, 3, 6 and 12 months
Fear of Recurrence
Time frame: Baseline, 3, 6 and 12 months

Results and safety

Results posted to the registry on 1 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Supervised Exercise Together)	164	148
Arm II (Supervised Exercise Separately)	170	148
Arm III (Unsupervised Exercise Separately)	162	126

Primary outcome: Dyadic Coping - Active Engagement

Time frame: Baseline, 3, 6 and 12 months. Mean (95% Confidence Interval). Unit: score on a scale per 6 months

Measure	Arm I (Supervised Exercise Together) n = 164	Arm II (Supervised Exercise Separately) n = 170	Arm III (Unsupervised Exercise Separately) n = 162
Survivor: Baseline-6mo	-0.45 (-1.16 to 0.27)	0.81 (0.11 to 1.50)	0.07 (-0.68 to 0.83)
Survivor: 6mo-12mo	-0.35 (-1.01 to 0.30)	-0.61 (-1.26 to 0.03)	-0.08 (-0.79 to 0.63)
Partner: Baseline-6mo	0.05 (-0.61 to 0.71)	-0.08 (-0.72 to 0.57)	-0.91 (-1.62 to -0.19)
Partner: 6mo-12mo	-0.52 (-1.20 to 0.16)	-0.14 (-0.81 to 0.54)	-0.35 (-1.09 to 0.39)

Population analysed: Overall number of participants analyzed are total number of individuals (survivors + partners)

Primary outcome: Dyadic Coping - Protective Buffering

Time frame: Baseline, 3, 6, and 12 months. Mean (95% Confidence Interval). Unit: Score on a scale per 6 months

Measure	Arm I (Supervised Exercise Together) n = 164	Arm II (Supervised Exercise Separately) n = 170	Arm III (Unsupervised Exercise Separately) n = 162
Survivor: Baseline-6mo	-0.48 (-1.24 to 0.29)	-0.18 (-0.93 to 0.57)	-0.13 (-0.93 to 0.66)
Survivor: 6mo-12mo	-0.21 (-0.91 to 0.50)	-0.46 (-1.16 to 0.24)	-0.57 (-1.34 to 0.20)
Partner: Baseline-6mo	0.36 (-0.39 to 1.10)	-0.09 (-0.81 to 0.62)	0.36 (-0.44 to 1.15)
Partner: 6mo-12mo	-0.04 (-0.75 to 0.68)	-0.20 (-0.91 to 0.51)	-0.27 (-1.07 to 0.54)

Population analysed: Overall number of participants analyzed are total number of individuals (survivors + partners)

Primary outcome: Emotional Intimacy

Time frame: Baseline, 3, 6 and 12 months. Mean (95% Confidence Interval). Unit: Score on a scale per 6 months

Measure	Arm I (Supervised Exercise Together) n = 164	Arm II (Supervised Exercise Separately) n = 170	Arm III (Unsupervised Exercise Separately) n = 162
Survivor: Baseline-6mo	3.37 (.78 to 5.97)	2.61 (.06 to 5.15)	2.97 (.20 to 5.73)
Survivor: 6mo-12mo	-2.87 (-5.84 to .10)	-2.30 (-5.26 to .67)	-1.33 (-4.66 to 2.01)
Partner: Baseline-6mo	.98 (-1.25 to 3.20)	1.90 (-.24 to 4.05)	-.99 (-3.42 to 1.43)
Partner: 6mo-12mo	-2.63 (-5.01 to -.26)	-.43 (-2.73 to 1.88)	1.96 (-.64 to 4.56)

Population analysed: Overall number of participants analyzed are total number of individuals (survivors + partners)

Primary outcome: Physical Intimacy - Engagement in Sex

Time frame: Baseline, 3, 6 and 12 months. Mean (95% Confidence Interval). Unit: Score on a scale per 6 months

Measure	Arm I (Supervised Exercise Together) n = 151	Arm II (Supervised Exercise Separately) n = 161	Arm III (Unsupervised Exercise Separately) n = 138
Survivor: Baseline-6mo	0.08 (-0.23 to 0.40)	-0.04 (-0.34 to 0.26)	-0.07 (-0.42 to 0.29)
Survivor: 6mo-12mo	-0.02 (-0.29 to 0.24)	0.19 (-0.07 to 0.44)	-0.02 (-0.32 to 0.28)
Partner: Baseline-6mo	0.10 (-0.20 to 0.39)	0.16 (-0.11 to 0.43)	-0.08 (-0.41 to 0.24)
Partner: 6mo-12mo	-0.12 (-0.41 to 0.17)	-0.23 (-0.50 to 0.05)	0.03 (-0.30 to 0.35)

Population analysed: This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Supervised Exercise Together)	4 of 164 (2.4%)	9 of 164 (5.5%)	0 of 164
Arm II (Supervised Exercise Separately)	2 of 170 (1.2%)	6 of 170 (3.5%)	0 of 170
Arm III (Unsupervised Exercise Separately)	1 of 162 (0.6%)	3 of 162 (1.9%)	0 of 162

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42077327Winters-Stone K, Stoyles SA, Dieckmann N, Sokolova AO, Graff JN, Hung A, Wang S, Lyons KS. Loneliness within couples coping with cancer: prevalence, associations with physical and mental health, and potential benefits of dyadic exercise. Front Aging. 2026 Apr 17;7:1812899. doi: 10.3389/fragi.2026.1812899. eCollection 2026.
Derived from this study: PubMed 36435952Skiba 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.
Derived from this study: PubMed 34741653Winters-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.
Derived from this study: PubMed 34461975Winters-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.
Individual participant dataSharing planned: Yes. All individual quantitative participant data collected during the trial, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kerri Winters-Stone principal investigator

OHSU Knight Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dyadic Coping - Active Engagement (time frame: Baseline, 3, 6 and 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630354, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.