N/A
N=496
EXERCISING TOGETHER for Couples Coping With Cancer
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
Bottom Line
View on ClinicalTrials.gov: NCT03630354 ↗Enrolled (actual)
496
Serious AEs
1.4%
Results posted
Jul 2025
Primary outcome: Primary: Dyadic Coping - Active Engagement — -0.45; 0.81; 0.07; -0.35 score on a scale per 6 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Intervention (supervised) (Behavioral); Exercise Intervention (unsupervised) (Behavioral); Informational Intervention (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyadic Coping - Active Engagement |
-0.45; 0.81; 0.07; -0.35; -0.61; -0.08 | — |
| PRIMARY Dyadic Coping - Protective Buffering |
-0.48; -0.18; -0.13; -0.21; -0.46; -0.57 | — |
| PRIMARY Emotional Intimacy |
3.37; 2.61; 2.97; -2.87; -2.30; -1.33 | — |
| PRIMARY Physical Intimacy - Engagement in Sex |
0.08; -0.04; -0.07; -0.02; 0.19; -0.02 | — |
| PRIMARY Physical Intimacy - Engagement in Affectionate Behaviors |
0.37; 0.08; 0.19; -0.04; 0.02; 0.15 | — |
| PRIMARY Concealment of Symptoms |
-.24; .07; -.82; -.23; -.18; .53 | — |
| PRIMARY Pain Incongruence - Pain Intensity |
.17; .08; .16; -.08; .16; .16 | — |
| PRIMARY Pain Incongruence - Pain Interference |
-.38; .01; -.05; .27; -.09; .16 | — |
| PRIMARY Fatigue Incongruence |
1.02; -1.24; -.41; -1.20; -.03; -.67 | — |
| PRIMARY Perceived Physical Function Incongruence |
.41; -.66; -.83; 1.33; .62; 1.29 | — |
| SECONDARY Body Composition - Bone-free Lean Mass |
3.38; 3.19; 3.19; -0.89; -0.60; -1.04 | — |
| SECONDARY Body Composition - Fat Mass |
-3.32; -3.50; -2.77; 1.38; 1.05; 0.53 | — |
| SECONDARY Cardiovascular Health: Serum Cholesterol |
-4.23; 2.74; -6.45; 3.77; -0.71; 2.68 | — |
| SECONDARY Cardiovascular Health: Serum Triglycerides |
-9.86; 7.00; -9.76; 4.79; -0.15; 12.02 | — |
| SECONDARY Cardiovascular Health: Insulin Resistance |
-0.06; -0.02; -0.01; -0.05; 0.01; -0.03 | — |
| SECONDARY Cardiovascular Health: Resting Systolic Blood Pressure |
-4.91; -5.50; -3.34; 0.83; 3.46; 2.38 | — |
| SECONDARY Cardiovascular Health: Resting Diastolic Blood Pressure |
-2.07; -4.10; -2.34; 1.42; 1.14; 1.48 | — |
| SECONDARY Inflammation-hsCRP |
-0.11; 0.09; -0.05; -0.12; -0.20; 0.13 | — |
| SECONDARY Inflammation-TNF Alpha |
-0.01; -0.02; -0.03; -0.01; -0.02; -0.01 | — |
| SECONDARY Objective Physical Function |
0.75; 0.86; 0.73; -0.03; -0.07; -0.30 | — |
| SECONDARY Quality of Life (QOL): QLQ-C30 - Physical Functioning |
2.12; 1.23; 1.26; -1.44; -0.30; 1.74 | — |
| SECONDARY Quality of Life (QOL): QLQ-C30 - Emotional Functioning |
4.18; 1.82; 4.67; -0.34; -0.39; -1.99 | — |
| SECONDARY Quality of Life (QOL): SF-36 Physical Function Subscale |
1.73; 2.47; 0.96; -0.76; -0.56; -0.81 | — |
| SECONDARY Depressive Symptoms: CES-D |
-1.50; -0.72; -1.10; -0.10; 0.26; -0.21 | — |
| SECONDARY Anxiety: PROMIS Anxiety Short Form |
-1.93; -2.23; -1.18; -0.30; 0.42; -0.23 | — |
| SECONDARY Fear of Recurrence |
-2.61; -2.48; -3.72; -1.63; -1.72; -0.31 | — |
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.
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 ( 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.)
Data sourced from ClinicalTrials.gov (NCT03630354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.