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NCT03630354

EXERCISING TOGETHER for Couples Coping With Cancer

Completed NA Results posted Last updated 1 July 2025
What this trial tests

NA trial testing Exercise Intervention (supervised) in Anatomic Stage I Breast Cancer AJCC v8 in 496 participants. Completed in 31 March 2024.

Timeline
18 January 2019
Primary endpoint
1 January 2024
31 March 2024

Quick facts

Lead sponsorOHSU Knight Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment496
Start date18 January 2019
Primary completion1 January 2024
Estimated completion31 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

OHSU Knight Cancer Institute

Who can join

Adults 35 to 80, any sex, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dyadic Coping - Active Engagement Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.45-1.16 – 0.27
Arm II (Supervised Exercise Separately)0.810.11 – 1.50
Arm III (Unsupervised Exercise Separately)0.07-0.68 – 0.83
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.35-1.01 – 0.30
Arm II (Supervised Exercise Separately)-0.61-1.26 – 0.03
Arm III (Unsupervised Exercise Separately)-0.08-0.79 – 0.63
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.05-0.61 – 0.71
Arm II (Supervised Exercise Separately)-0.08-0.72 – 0.57
Arm III (Unsupervised Exercise Separately)-0.91-1.62 – -0.19
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.52-1.20 – 0.16
Arm II (Supervised Exercise Separately)-0.14-0.81 – 0.54
Arm III (Unsupervised Exercise Separately)-0.35-1.09 – 0.39
Dyadic Coping - Protective Buffering Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.48-1.24 – 0.29
Arm II (Supervised Exercise Separately)-0.18-0.93 – 0.57
Arm III (Unsupervised Exercise Separately)-0.13-0.93 – 0.66
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.21-0.91 – 0.50
Arm II (Supervised Exercise Separately)-0.46-1.16 – 0.24
Arm III (Unsupervised Exercise Separately)-0.57-1.34 – 0.20
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.36-0.39 – 1.10
Arm II (Supervised Exercise Separately)-0.09-0.81 – 0.62
Arm III (Unsupervised Exercise Separately)0.36-0.44 – 1.15
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.04-0.75 – 0.68
Arm II (Supervised Exercise Separately)-0.20-0.91 – 0.51
Arm III (Unsupervised Exercise Separately)-0.27-1.07 – 0.54
Emotional Intimacy Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)3.37.78 – 5.97
Arm II (Supervised Exercise Separately)2.61.06 – 5.15
Arm III (Unsupervised Exercise Separately)2.97.20 – 5.73
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-2.87-5.84 – .10
Arm II (Supervised Exercise Separately)-2.30-5.26 – .67
Arm III (Unsupervised Exercise Separately)-1.33-4.66 – 2.01
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together).98-1.25 – 3.20
Arm II (Supervised Exercise Separately)1.90-.24 – 4.05
Arm III (Unsupervised Exercise Separately)-.99-3.42 – 1.43
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-2.63-5.01 – -.26
Arm II (Supervised Exercise Separately)-.43-2.73 – 1.88
Arm III (Unsupervised Exercise Separately)1.96-.64 – 4.56
Physical Intimacy - Engagement in Sex Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.08-0.23 – 0.40
Arm II (Supervised Exercise Separately)-0.04-0.34 – 0.26
Arm III (Unsupervised Exercise Separately)-0.07-0.42 – 0.29
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.02-0.29 – 0.24
Arm II (Supervised Exercise Separately)0.19-0.07 – 0.44
Arm III (Unsupervised Exercise Separately)-0.02-0.32 – 0.28
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.10-0.20 – 0.39
Arm II (Supervised Exercise Separately)0.16-0.11 – 0.43
Arm III (Unsupervised Exercise Separately)-0.08-0.41 – 0.24
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.12-0.41 – 0.17
Arm II (Supervised Exercise Separately)-0.23-0.50 – 0.05
Arm III (Unsupervised Exercise Separately)0.03-0.30 – 0.35
Physical Intimacy - Engagement in Affectionate Behaviors Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.37-0.18 – 0.92
Arm II (Supervised Exercise Separately)0.08-0.45 – 0.60
Arm III (Unsupervised Exercise Separately)0.19-0.41 – 0.79
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.04-0.57 – 0.49
Arm II (Supervised Exercise Separately)0.02-0.50 – 0.54
Arm III (Unsupervised Exercise Separately)0.15-0.45 – 0.74
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.30-0.22 – 0.82
Arm II (Supervised Exercise Separately)0.29-0.22 – 0.79
Arm III (Unsupervised Exercise Separately)0.23-0.36 – 0.82
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.37-0.93 – 0.18
Arm II (Supervised Exercise Separately)-0.18-0.72 – 0.36
Arm III (Unsupervised Exercise Separately)-0.15-0.79 – 0.50
Concealment of Symptoms Primary · 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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-.24-.88 – .40
Arm II (Supervised Exercise Separately).07-.56 – .69
Arm III (Unsupervised Exercise Separately)-.82-1.52 – -.11
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-.23-.82 – .36
Arm II (Supervised Exercise Separately)-.18-.77 – .41
Arm III (Unsupervised Exercise Separately).53-.14 – 1.20
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-.33-.98 – .33
Arm II (Supervised Exercise Separately)-.44-1.07 – .22
Arm III (Unsupervised Exercise Separately)-.70-1.41 – .01
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together).63.04 – 1.23
Arm II (Supervised Exercise Separately)-.23-.82 – .36
Arm III (Unsupervised Exercise Separately)-.11-.76 – .55
Pain Incongruence - Pain Intensity Primary · 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.

Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together).17-.13 – .47
Arm II (Supervised Exercise Separately).08-.22 – .37
Arm III (Unsupervised Exercise Separately).16-.16 – .48
6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-.08-.38 – .21
Arm II (Supervised Exercise Separately).16-.14 – .44
Arm III (Unsupervised Exercise Separately).16-.16 – .48
Pain Incongruence - Pain Interference Primary · 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.

Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-.38-.70 – -.07
Arm II (Supervised Exercise Separately).01-.30 – .32
Arm III (Unsupervised Exercise Separately)-.05-.38 – .29
6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together).27-.04 – .58
Arm II (Supervised Exercise Separately)-.09-.39 – .21
Arm III (Unsupervised Exercise Separately).16-.17 – .50
Fatigue Incongruence Primary · 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.

Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)1.02-.28 – 2.32
Arm II (Supervised Exercise Separately)-1.24-2.50 – .03
Arm III (Unsupervised Exercise Separately)-.41-1.80 – .98
6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-1.20-2.49 – .10
Arm II (Supervised Exercise Separately)-.03-1.30 – 1.24
Arm III (Unsupervised Exercise Separately)-.67-2.08 – .74
Perceived Physical Function Incongruence Primary · 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.

Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together).41-.87 – 1.68
Arm II (Supervised Exercise Separately)-.66-1.90 – .59
Arm III (Unsupervised Exercise Separately)-.83-2.19 – .53
6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)1.33.05 – 2.61
Arm II (Supervised Exercise Separately).62-.64 – 1.88
Arm III (Unsupervised Exercise Separately)1.29-.10 – 2.69
Body Composition - Bone-free Lean Mass Secondary · Baseline, 3, 6 and 12 months

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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)3.382.88 – 3.88
Arm II (Supervised Exercise Separately)3.192.71 – 3.67
Arm III (Unsupervised Exercise Separately)3.192.61 – 3.77
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-0.89-1.38 – -0.39
Arm II (Supervised Exercise Separately)-0.60-1.06 – -0.14
Arm III (Unsupervised Exercise Separately)-1.04-1.59 – -0.49
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)3.202.73 – 3.67
Arm II (Supervised Exercise Separately)3.322.86 – 3.79
Arm III (Unsupervised Exercise Separately)3.172.62 – 3.72
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-1.43-1.96 – -0.90
Arm II (Supervised Exercise Separately)-1.03-1.53 – -0.52
Arm III (Unsupervised Exercise Separately)-1.05-1.64 – -0.46
Body Composition - Fat Mass Secondary · Baseline, 3, 6, and 12 months

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.

Survivor: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-3.32-3.94 – -2.71
Arm II (Supervised Exercise Separately)-3.50-4.10 – -2.91
Arm III (Unsupervised Exercise Separately)-2.77-3.49 – -2.05
Survivor: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)1.380.80 – 1.96
Arm II (Supervised Exercise Separately)1.050.52 – 1.59
Arm III (Unsupervised Exercise Separately)0.53-0.12 – 1.18
Partner: Baseline-6mo
GroupValue95% CI
Arm I (Supervised Exercise Together)-3.63-4.17 – -3.09
Arm II (Supervised Exercise Separately)-3.36-3.90 – -2.83
Arm III (Unsupervised Exercise Separately)-3.16-3.79 – -2.52
Partner: 6mo-12mo
GroupValue95% CI
Arm I (Supervised Exercise Together)0.22-0.56 – 0.99
Arm II (Supervised Exercise Separately)0.870.14 – 1.60
Arm III (Unsupervised Exercise Separately)0.25-0.62 – 1.11

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Supervised Exercise Together)
Serious: 4/164 (2%)
Deaths: 0/164
Arm II (Supervised Exercise Separately)
Serious: 2/170 (1%)
Deaths: 0/170
Arm III (Unsupervised Exercise Separately)
Serious: 1/162 (1%)
Deaths: 0/162

Serious adverse events (4 terms)

ReactionSystemArm I (Supervised Exercise…Arm II (Supervised Exercis…Arm III (Unsupervised Exer…
Abscess - survivorsInfections and infestations
Surgery - survivorsSurgical and medical procedures
TIA - survivorsVascular disorders
Surgery - partnersSurgical and medical procedures
Other adverse events (1 terms — click to expand)

ReactionSystemArm I (Supervised Exercise…Arm II (Supervised Exercis…Arm III (Unsupervised Exer…
Joint or muscle pain - survivorsMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Abscess - survivors, Surgery - survivors, TIA - survivors, Surgery - partners.

Data from ClinicalTrials.gov NCT03630354 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Physical activity interventions for disease-related physical and mental health during and following treatment in people with non-advanced colorectal cancer.
    McGettigan M, Cardwell CR, Cantwell MM, Tully MA. · · 2020 · cited 52× · PMID 32361988 · DOI 10.1002/14651858.cd012864.pub2
  2. Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise?
    Winters-Stone KM, Boisvert C, Li F, Lyons KS, et al · · 2022 · cited 33× · PMID 34741653 · DOI 10.1007/s00520-021-06669-w
  3. Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.
    Chan JM, Van Blarigan EL, Langlais CS, Zhao S, et al · · 2020 · cited 31× · PMID 33382378 · DOI 10.2196/19238
  4. Remote administration of physical performance tests among persons with and without a cancer history: Establishing reliability and agreement with in-person assessment.
    Guidarelli C, Lipps C, Stoyles S, Dieckmann NF, et al · · 2022 · cited 22× · PMID 35177378 · DOI 10.1016/j.jgo.2022.02.002
  5. Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer.
    Winters-Stone KM, Lyons KS, Dieckmann NF, Lee CS, et al · · 2021 · cited 14× · PMID 34461975 · DOI 10.1186/s13063-021-05548-3
  6. Associations between perceptions of relationship quality and markers of inflammation and insulin resistance among couples coping with cancer.
    Skiba MB, Dieckmann NF, Lyons KS, Winters-Stone KM. · · 2023 · cited 1× · PMID 36435952 · DOI 10.1007/s11764-022-01299-5
  7. Loneliness within couples coping with cancer: prevalence, associations with physical and mental health, and potential benefits of dyadic exercise.
    Winters-Stone K, Stoyles SA, Dieckmann N, Sokolova AO, et al · · 2026 · PMID 42077327 · DOI 10.3389/fragi.2026.1812899

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Data sources for this page

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