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EXERCISING TOGETHER for Couples Coping With Cancer

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Exercise Intervention
Informational Intervention
Questionnaire Administration
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm I (supervised exercise together)

Arm II (supervised exercise separately)

Arm III (unsupervised exercise separately)

Arm Description

Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.

Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.

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.

Outcomes

Primary Outcome Measures

Dyadic coping
Measured by the Relationship Focused Coping Scale to assess the degree with which couples practice active engagement and protective buffering using questions on a scale from 1 (never) to 5 (very often).
Emotional intimacy
Measured by the Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree).
Physical intimacy
Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in, initiate, and avoid intimate behaviors using questions on scale from 1 (none of the time) to 4 (most or all of the time).
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).
Pain incongruence
Measured by the degree of agreement 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".
Fatigue incongruence
Measured by the degree of agreement 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.
Perceived physical function incongruence
Measured by the degree of agreement 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.

Secondary Outcome Measures

Body composition
Measured by bone-free lean and fat mass (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.
Cardiovascular health: serum fasting lipids
Measured by serum fasting lipids (total, high-density and low-density lipoprotein cholesterol and triglycerides).
Cardiovascular health: insulin resistance
Measured by Homeostasis Model Assessment - Insulin Resistance - HOMA-IR: as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant.
Cardiovascular health: resting blood pressure
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Inflammation-hsCRP
Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.
Inflammation-TNF alpha
Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.
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.
Quality of life (QOL): QLQ-C30
Measures QOL in cancer patients including subscales of physical and mental functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Quality of life (QOL): SF-36
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 QOL, while higher scores indicate better QOL.
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.
Anxiety: PROMIS anxiety short form
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
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 questions ranging from 1 (strongly agree) to 5 (strongly disagree).

Full Information

First Posted
August 3, 2018
Last Updated
July 9, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03630354
Brief Title
EXERCISING TOGETHER for Couples Coping With Cancer
Official Title
EXERCISING TOGETHER © for Couples Coping With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
Detailed Description
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: Couples perform partnered exercise over 1 hour, 2 days per week 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Malignant Solid Neoplasm, Prostate Carcinoma, Stage I Colorectal Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (supervised exercise together)
Arm Type
Experimental
Arm Description
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months.
Arm Title
Arm II (supervised exercise separately)
Arm Type
Experimental
Arm Description
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months.
Arm Title
Arm III (unsupervised exercise separately)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete supervised exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete unsupervised exercise
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive instructional DVD
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Dyadic coping
Description
Measured by the Relationship Focused Coping Scale to assess the degree with which couples practice active engagement and protective buffering using questions on a scale from 1 (never) to 5 (very often).
Time Frame
Baseline (just prior to randomization), 3, 6 and 12 months
Title
Emotional intimacy
Description
Measured by the Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree).
Time Frame
Baseline, 3, 6 and 12 months
Title
Physical intimacy
Description
Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in, initiate, and avoid intimate behaviors using questions on scale from 1 (none of the time) to 4 (most or all of the time).
Time Frame
Baseline, 3, 6 and 12 months
Title
Concealment of symptoms
Description
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).
Time Frame
Baseline, 3, 6 and 12 months
Title
Pain incongruence
Description
Measured by the degree of agreement 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".
Time Frame
Baseline, 3, 6 and 12 months
Title
Fatigue incongruence
Description
Measured by the degree of agreement 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.
Time Frame
Baseline, 3, 6 and 12 months
Title
Perceived physical function incongruence
Description
Measured by the degree of agreement 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.
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Body composition
Description
Measured by bone-free lean and fat mass (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
Title
Cardiovascular health: serum fasting lipids
Description
Measured by serum fasting lipids (total, high-density and low-density lipoprotein cholesterol and triglycerides).
Time Frame
Baseline, 3, 6 and 12 months
Title
Cardiovascular health: insulin resistance
Description
Measured by Homeostasis Model Assessment - Insulin Resistance - HOMA-IR: as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant.
Time Frame
Baseline, 3, 6 and 12 months
Title
Cardiovascular health: resting blood pressure
Description
Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Time Frame
Baseline, 3, 6 and 12 months
Title
Inflammation-hsCRP
Description
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
Title
Inflammation-TNF alpha
Description
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
Title
Objective physical function
Description
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
Title
Quality of life (QOL): QLQ-C30
Description
Measures QOL in cancer patients including subscales of physical and mental 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
Title
Quality of life (QOL): SF-36
Description
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 QOL, while higher scores indicate better QOL.
Time Frame
Baseline, 3, 6 and 12 months
Title
Depressive symptoms: CES-D
Description
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
Title
Anxiety: PROMIS anxiety short form
Description
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
Time Frame
Baseline, 3, 6 and 12 months
Title
Fear of recurrence
Description
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 questions ranging from 1 (strongly agree) to 5 (strongly disagree).
Time Frame
Baseline, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 (< 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34741653
Citation
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.
Results Reference
derived
PubMed Identifier
34461975
Citation
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.
Results Reference
derived

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EXERCISING TOGETHER for Couples Coping With Cancer

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