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Completed

NCT Number: NCT03630354

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (< 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)

Exclusion criteria

  • 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.)

Treatment and study plan

Exercise Intervention (supervised)

Behavioral

Complete supervised exercise

Exercise Intervention (unsupervised)

Behavioral

Complete unsupervised exercise

Informational intervention

Other

Receive instructional DVD

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. Body Composition - Bone-free Lean Mass

    Time frame: 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.

  2. Body Composition - Fat Mass

    Time frame: 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.

  3. Cardiovascular Health: Serum Cholesterol

    Time frame: Baseline, 3, 6 and 12 months

    Measured by serum fasting total cholesterol.

  4. Cardiovascular Health: Serum Triglycerides

    Time frame: Baseline, 3, 6, and 12 months

    Measured by serum triglycerides.

  5. Cardiovascular Health: Insulin Resistance

    Time frame: Baseline, 3, 6 and 12 months

    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

  6. Cardiovascular Health: Resting Systolic Blood Pressure

    Time frame: Baseline, 3, 6 and 12 months

    Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).

  7. Cardiovascular Health: Resting Diastolic Blood Pressure

    Time frame: Baseline, 3, 6, 12 months

    Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).

  8. Inflammation-hsCRP

    Time frame: Baseline, 3, 6 and 12 months

    Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.

  9. Inflammation-TNF Alpha

    Time frame: Baseline, 3, 6 and 12 months

    Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.

  10. Objective Physical Function

    Time frame: Baseline, 3, 6 and 12 months

    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.

  11. Quality of Life (QOL): QLQ-C30 - Physical Functioning

    Time frame: Baseline, 3, 6 and 12 months

    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.

  12. Quality of Life (QOL): QLQ-C30 - Emotional Functioning

    Time frame: Baseline, 3, 6, 12 months

    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.

  13. Quality of Life (QOL): SF-36 Physical Function Subscale

    Time frame: Baseline, 3, 6 and 12 months

    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.

  14. Depressive Symptoms: CES-D

    Time frame: Baseline, 3, 6 and 12 months

    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.

  15. Anxiety: PROMIS Anxiety Short Form

    Time frame: Baseline, 3, 6 and 12 months

    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.

  16. Fear of Recurrence

    Time frame: Baseline, 3, 6 and 12 months

    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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • Oregon Health and Science University

Registry information

Official study title

EXERCISING TOGETHER © for Couples Coping With Cancer

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2018
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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