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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
496
Complete supervised exercise
Complete unsupervised exercise
Receive instructional DVD
Ancillary studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3, 6 and 12 months
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.
Time frame: 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.
Time frame: Baseline, 3, 6, and 12 months
Cardiovascular Health: Serum Cholesterol
Measured by serum fasting total cholesterol.
Time frame: Baseline, 3, 6 and 12 months
Cardiovascular Health: Serum Triglycerides
Measured by serum triglycerides.
Time frame: 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
Time frame: 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).
Time frame: Baseline, 3, 6 and 12 months
Cardiovascular Health: Resting Diastolic Blood Pressure
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Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Time frame: Baseline, 3, 6, 12 months
Inflammation-hsCRP
Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3, 6 and 12 months