EXERCISING TOGETHER © for Couples Coping With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 2
- 主要终点
- Dyadic Coping - Active Engagement
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.)
研究组 & 干预措施
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.
干预措施: Exercise Intervention (supervised) (Behavioral)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Exercise Intervention (supervised) (Behavioral)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Exercise Intervention (unsupervised) (Behavioral)
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.
干预措施: Informational Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Dyadic Coping - Active Engagement
时间窗: 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.
Dyadic Coping - Protective Buffering
时间窗: 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.
Emotional Intimacy
时间窗: 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.
Physical Intimacy - Engagement in Sex
时间窗: 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.
Physical Intimacy - Engagement in Affectionate Behaviors
时间窗: 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.
Concealment of Symptoms
时间窗: 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.
Pain Incongruence - Pain Intensity
时间窗: 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.
Pain Incongruence - Pain Interference
时间窗: 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.
Fatigue Incongruence
时间窗: 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.
Perceived Physical Function Incongruence
时间窗: 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.
Dyadic Coping - Active Engagement
时间窗: 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.
Dyadic Coping - Protective Buffering
时间窗: 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.
Emotional Intimacy
时间窗: 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.
Physical Intimacy - Engagement in Affectionate Behaviors
时间窗: 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.
Pain Incongruence - Pain Intensity
时间窗: 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.
Pain Incongruence - Pain Interference
时间窗: 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.
Fatigue Incongruence
时间窗: 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.
Perceived Physical Function Incongruence
时间窗: 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.
次要结局
- Body Composition - Bone-free Lean Mass(Baseline, 3, 6 and 12 months)
- Body Composition - Fat Mass(Baseline, 3, 6, and 12 months)
- Cardiovascular Health: Serum Cholesterol(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Serum Triglycerides(Baseline, 3, 6, and 12 months)
- Cardiovascular Health: Insulin Resistance(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Resting Systolic Blood Pressure(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Resting Diastolic Blood Pressure(Baseline, 3, 6, 12 months)
- Inflammation-hsCRP(Baseline, 3, 6 and 12 months)
- Inflammation-TNF Alpha(Baseline, 3, 6 and 12 months)
- Objective Physical Function(Baseline, 3, 6 and 12 months)
- Quality of Life (QOL): QLQ-C30 - Physical Functioning(Baseline, 3, 6 and 12 months)
- Quality of Life (QOL): QLQ-C30 - Emotional Functioning(Baseline, 3, 6, 12 months)
- Quality of Life (QOL): SF-36 Physical Function Subscale(Baseline, 3, 6 and 12 months)
- Depressive Symptoms: CES-D(Baseline, 3, 6 and 12 months)
- Anxiety: PROMIS Anxiety Short Form(Baseline, 3, 6 and 12 months)
- Fear of Recurrence(Baseline, 3, 6 and 12 months)
- Objective Physical Function(Baseline, 3, 6 and 12 months)
- Quality of Life (QOL): QLQ-C30 - Physical Functioning(Baseline, 3, 6 and 12 months)
- Quality of Life (QOL): QLQ-C30 - Emotional Functioning(Baseline, 3, 6, 12 months)
- Inflammation-hsCRP(Baseline, 3, 6 and 12 months)
- Body Composition - Bone-free Lean Mass(Baseline, 3, 6 and 12 months)
- Body Composition - Fat Mass(Baseline, 3, 6, and 12 months)
- Cardiovascular Health: Serum Cholesterol(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Serum Triglycerides(Baseline, 3, 6, and 12 months)
- Cardiovascular Health: Insulin Resistance(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Resting Systolic Blood Pressure(Baseline, 3, 6 and 12 months)
- Cardiovascular Health: Resting Diastolic Blood Pressure(Baseline, 3, 6, 12 months)
- Inflammation-TNF Alpha(Baseline, 3, 6 and 12 months)
- Quality of Life (QOL): SF-36 Physical Function Subscale(Baseline, 3, 6 and 12 months)
- Anxiety: PROMIS Anxiety Short Form(Baseline, 3, 6 and 12 months)
- Fear of Recurrence(Baseline, 3, 6 and 12 months)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute