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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01404 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00018000 | Other Identifier | OHSU Knight Cancer Institute | |
| R01CA218093 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
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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.
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: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention (supervised) | Behavioral | Complete supervised exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3, 6 and 12 months |
| Body Composition - Fat Mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Winters-Stone | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42077327 | Derived | 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. | |
| 36435952 | Derived | 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. |
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All individual quantitative participant data collected during the trial, after deidentification.
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Beginning 3 months following final publication.
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.
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Of 269 consented couples, 248 couples (496 individuals: 248 survivors + 248 partners) met inclusion criteria and were randomized to an intervention group.
Community-dwelling couples were recruited between January 2019 and October 2022. The first couple was enrolled on January 18, 2019 and the last was couple was enrolled on October 26, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Supervised Exercise Together) | Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies |
| FG001 | Arm II (Supervised Exercise Separately) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2024 |
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| Exercise Intervention (unsupervised) | Behavioral | Complete unsupervised exercise |
|
| Informational Intervention | Other | Receive instructional DVD |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
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. |
| Baseline, 3, 6, and 12 months |
| Cardiovascular Health: Serum Cholesterol | Measured by serum fasting total cholesterol. | Baseline, 3, 6 and 12 months |
| Cardiovascular Health: Serum Triglycerides | Measured by serum triglycerides. | 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 | 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). | 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). | Baseline, 3, 6, 12 months |
| Inflammation-hsCRP | Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 3, 6 and 12 months |
| 34741653 | 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. |
| 34461975 | 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. |
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies |
| FG002 | Arm III (Unsupervised Exercise Separately) | 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. Exercise Intervention: Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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Overall number of baseline participants reflect total number of individuals (survivors + partners).
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Supervised Exercise Together) | Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (Supervised Exercise Separately) | Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies |
| BG002 | Arm III (Unsupervised Exercise Separately) | 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. Exercise Intervention: Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Survivors | Survivors only | Mean | Standard Deviation | years |
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| Age, Continuous | Partners | Partners only | Mean | Standard Deviation | years |
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| Sex: Female, Male | Survivors | Survivors only | Count of Participants | Participants |
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| Sex: Female, Male | Partners | Partners only | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Survivors | Survivors only | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Partners | Partners only | Count of Participants | Participants |
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| Race (NIH/OMB) | Survivors | Survivors only | Count of Participants | Participants |
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| Race (NIH/OMB) | Partners | Partners only | Count of Participants | Participants |
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| Region of Enrollment | Survivors | Survivors only | Count of Participants | Participants |
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| Region of Enrollment | Partners | Partners only | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6, and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6, and 12-months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Primary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | kg per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | kg per 6 months | Baseline, 3, 6, and 12 months |
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| Secondary | Cardiovascular Health: Serum Cholesterol | Measured by serum fasting total cholesterol. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | mg/dL per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | Cardiovascular Health: Serum Triglycerides | Measured by serum triglycerides. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | mg/dL per 6 months | Baseline, 3, 6, and 12 months |
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| Secondary | 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 | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | Cardiovascular Health: Resting Systolic Blood Pressure | Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures). | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | mmHg per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | Cardiovascular Health: Resting Diastolic Blood Pressure | Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures). | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | mmHg per 6 months | Baseline, 3, 6, 12 months |
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| Secondary | Inflammation-hsCRP | Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | mg/L per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | Inflammation-TNF Alpha | Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | pg/mL per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are survivors only since this scale is cancer survivor specific. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are survivors only since this scale is cancer survivor specific. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6, 12 months |
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| Secondary | 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. | This measure had a significant amount of missing data for partners (due to a survey logic error) so the total sample size is reduced. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are total number of individuals (survivors + partners) | Posted | Mean | 95% Confidence Interval | T score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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| Secondary | 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. | Overall number of participants analyzed are survivors only since this scale is cancer survivor specific. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline, 3, 6 and 12 months |
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An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Supervised Exercise Together) | Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies | 0 | 164 | 4 | 164 | 9 | 164 |
| EG001 | Arm II (Supervised Exercise Separately) | Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies | 0 | 170 | 2 | 170 | 6 | 170 |
| EG002 | Arm III (Unsupervised Exercise Separately) | 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. Exercise Intervention: Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies | 0 | 162 | 1 | 162 | 3 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess - survivors | Infections and infestations | Systematic Assessment |
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| Surgery - survivors | Surgical and medical procedures | Systematic Assessment |
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| TIA - survivors | Vascular disorders | Systematic Assessment |
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| Surgery - partners | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint or muscle pain - survivors | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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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).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerri Winters-Stone | Oregon Health & Science University | 503-494-0813 | wintersk@ohsu.edu |
| Dec 31, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2022 | Nov 18, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Survivor: 6mo-12mo |
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| Partner: Baseline-6mo |
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| Partner: 6mo-12mo |
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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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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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.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
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|
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.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|
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.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|
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.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
|
|
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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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| Arm III (Unsupervised Exercise Separately) |
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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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| OG002 | Arm III (Unsupervised Exercise Separately) | 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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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| OG002 |
| Arm III (Unsupervised Exercise Separately) |
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. Exercise Intervention (unsupervised): Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies |
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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.
Exercise Intervention (unsupervised): Complete unsupervised exercise
Informational Intervention: Receive instructional DVD
Questionnaire Administration: Ancillary studies
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