EXERCISING TOGETHER for Couples Coping With Cancer

Breast Carcinoma Clinical Trial

Official title:

EXERCISING TOGETHER © for Couples Coping With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630354
• Other study ID #: STUDY00018000
• Secondary ID: NCI-2018-01404ST
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Malignant Solid Neoplasm
• Prostate Carcinoma
• Prostatic Neoplasms
• 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

Intervention

Behavioral:
• Exercise Intervention
Complete supervised exercise
• Exercise Intervention
Complete unsupervised exercise

Other:
• Informational Intervention
Receive instructional DVD
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (just prior to randomization), 3, 6 and 12 months
Primary	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).	Baseline, 3, 6 and 12 months
Primary	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).	Baseline, 3, 6 and 12 months
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).	Baseline, 3, 6 and 12 months
Primary	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".	Baseline, 3, 6 and 12 months
Primary	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.	Baseline, 3, 6 and 12 months
Primary	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.	Baseline, 3, 6 and 12 months
Secondary	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.	Baseline, 3, 6 and 12 months
Secondary	Cardiovascular health: serum fasting lipids	Measured by serum fasting lipids (total, high-density and low-density lipoprotein cholesterol and triglycerides).	Baseline, 3, 6 and 12 months
Secondary	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.	Baseline, 3, 6 and 12 months
Secondary	Cardiovascular health: resting blood pressure	Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).	Baseline, 3, 6 and 12 months
Secondary	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
Secondary	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
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.	Baseline, 3, 6 and 12 months
Secondary	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.	Baseline, 3, 6 and 12 months
Secondary	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.	Baseline, 3, 6 and 12 months
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.	Baseline, 3, 6 and 12 months
Secondary	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).	Baseline, 3, 6 and 12 months
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 questions ranging from 1 (strongly agree) to 5 (strongly disagree).	Baseline, 3, 6 and 12 months