Trial Outcomes & Findings for Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT) (NCT NCT00833898)
NCT ID: NCT00833898
Last Updated: 2015-12-09
Results Overview
The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
COMPLETED
PHASE3
298 participants
Baseline (prior to transplant), 1 and 3 post transplant
2015-12-09
Participant Flow
Caregivers and their patients were recruited consecutively between 11/2008 and 4/2012 during pre-transplant screening of all Allo-HSCT patients and their caregivers at a single site (Presbyterian St. Luke's Medical Center, Denver, CO).
149 patient-caregiver dyads were consented (298 participants) and 148 dyads were randomized. 1 dyad (2 participants) did not meet the inclusion criteria.
Participant milestones
| Measure |
Caregiver Control
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
Month 1 (Post Transplantation)
|
72
|
74
|
|
Overall Study
Month 3 (Post Transplantation)
|
66
|
64
|
|
Overall Study
Month 6 (Post Transplantation)
|
59
|
54
|
|
Overall Study
Month 12 (Post Transplantation)
|
50
|
50
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
40
|
36
|
Reasons for withdrawal
| Measure |
Caregiver Control
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
33
|
27
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Patient did not receive transplant
|
0
|
2
|
Baseline Characteristics
Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
Baseline characteristics by cohort
| Measure |
Caregiver Control
n=74 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=74 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 12.355 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 12.169 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 12.285 • n=5 Participants
|
|
Gender
Female
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Gender
Male
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian (not Latino/Hispanic)
|
68 participants
n=5 Participants
|
65 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American (not Latino/Hispanic)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic/Mexian-American
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Annual income
< 25,000
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Annual income
25,000-44,999
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Annual income
45,000-64,999
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Annual income
> 65,000
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Annual income
Unknown or Not Reported
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Relationship to patient
Spouse/partner
|
46 participants
n=5 Participants
|
57 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Relationship to patient
Parent
|
19 participants
n=5 Participants
|
8 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Relationship to patient
Other
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Relationship to patient
Unknown or Not Reported
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
Full-time
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
Part-time
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
Unemployed
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
On leave
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
Retired
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Employment Status (Before Caregiving)
Unknown or Not Reported
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
Full-time
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
Part-time
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
Unemployed
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
On leave
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
Retired
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Employment Status (During Caregiving)
Unknown or Not Reported
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).
The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
Outcome measures
| Measure |
Caregiver Control
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=72 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
Baseline
|
23.5 units on a scale
Interval 21.6 to 25.3
|
22.7 units on a scale
Interval 20.9 to 24.6
|
|
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
Month 1
|
21.6 units on a scale
Interval 19.7 to 23.5
|
22.0 units on a scale
Interval 20.1 to 23.8
|
|
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
Month 3
|
23.0 units on a scale
Interval 21.0 to 25.0
|
20.0 units on a scale
Interval 17.9 to 22.0
|
PRIMARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15).
Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.
Outcome measures
| Measure |
Caregiver Control
n=59 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=59 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Physiological - Cortisol Awakening Response (CAR)
Baseline
|
0.35 ln(nmol/L)
Interval 0.23 to 0.48
|
0.25 ln(nmol/L)
Interval 0.12 to 0.37
|
|
Physiological - Cortisol Awakening Response (CAR)
Month 1
|
0.33 ln(nmol/L)
Interval 0.18 to 0.48
|
0.36 ln(nmol/L)
Interval 0.2 to 0.52
|
|
Physiological - Cortisol Awakening Response (CAR)
Month 3
|
0.33 ln(nmol/L)
Interval 0.15 to 0.51
|
0.52 ln(nmol/L)
Interval 0.34 to 0.7
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2).
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.
Outcome measures
| Measure |
Caregiver Control
n=69 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=72 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)
Baseline
|
15.9 units on a scale
Interval 13.7 to 18.1
|
14.6 units on a scale
Interval 12.5 to 16.8
|
|
Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)
Month 1
|
13.8 units on a scale
Interval 11.8 to 15.8
|
13.6 units on a scale
Interval 11.6 to 15.5
|
|
Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)
Month 3
|
16.3 units on a scale
Interval 14.0 to 18.6
|
12.1 units on a scale
Interval 9.8 to 14.5
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).
The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).
Outcome measures
| Measure |
Caregiver Control
n=71 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Baseline
|
42.4 units on a scale
Interval 40.0 to 44.8
|
38.9 units on a scale
Interval 36.6 to 41.3
|
|
State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Month 1
|
38.8 units on a scale
Interval 36.4 to 41.2
|
38.0 units on a scale
Interval 35.7 to 40.4
|
|
State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Month 3
|
41.6 units on a scale
Interval 38.8 to 44.4
|
34.7 units on a scale
Interval 31.9 to 37.5
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1).
POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 - 200, with higher score indicating more mood disturbance.
Outcome measures
| Measure |
Caregiver Control
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)
Baseline
|
66.8 units on a scale
Interval 58.9 to 74.8
|
61.0 units on a scale
Interval 53.2 to 68.9
|
|
Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)
Month 1
|
58.0 units on a scale
Interval 50.2 to 65.7
|
59.4 units on a scale
Interval 51.8 to 67.0
|
|
Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)
Month 3
|
65.2 units on a scale
Interval 57.1 to 73.3
|
53.0 units on a scale
Interval 44.8 to 61.2
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1).
The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.
Outcome measures
| Measure |
Caregiver Control
n=69 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)
Baseline
|
10.4 units on a scale
Interval 9.9 to 10.8
|
10.2 units on a scale
Interval 9.7 to 10.6
|
|
Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)
Month 1
|
10.8 units on a scale
Interval 10.2 to 11.4
|
10.8 units on a scale
Interval 10.3 to 11.4
|
|
Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)
Month 3
|
10.9 units on a scale
Interval 10.3 to 11.5
|
10.6 units on a scale
Interval 9.9 to 11.2
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.
Outcome measures
| Measure |
Caregiver Control
n=71 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score
Month 3
|
11.2 units on a scale
Interval 10.5 to 11.9
|
11.0 units on a scale
Interval 10.3 to 11.7
|
|
Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score
Baseline
|
11.1 units on a scale
Interval 10.4 to 11.7
|
11.4 units on a scale
Interval 10.8 to 12.1
|
|
Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score
Month 1
|
11.2 units on a scale
Interval 10.6 to 11.9
|
11.2 units on a scale
Interval 10.6 to 11.9
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).
The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Outcome measures
| Measure |
Caregiver Control
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)
Baseline
|
42.7 units on a scale
Interval 40.1 to 45.3
|
45.1 units on a scale
Interval 42.6 to 47.7
|
|
Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)
Month 1
|
43.8 units on a scale
Interval 41.0 to 46.6
|
45.7 units on a scale
Interval 42.9 to 48.4
|
|
Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)
Month 3
|
43.5 units on a scale
Interval 40.6 to 46.4
|
47.0 units on a scale
Interval 43.9 to 50.0
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).
The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Outcome measures
| Measure |
Caregiver Control
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)
Baseline
|
53.8 units on a scale
Interval 51.9 to 55.7
|
54.7 units on a scale
Interval 52.8 to 56.6
|
|
Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)
Month 1
|
54.0 units on a scale
Interval 51.7 to 56.3
|
52.9 units on a scale
Interval 50.6 to 55.2
|
|
Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)
Month 3
|
53.7 units on a scale
Interval 51.6 to 55.8
|
54.0 units on a scale
Interval 51.8 to 56.1
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).
The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.
Outcome measures
| Measure |
Caregiver Control
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=72 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Stress as Measured by the Impact of Events Scale (IES)
Baseline
|
31.4 units on a scale
Interval 29.5 to 33.3
|
29.8 units on a scale
Interval 27.9 to 31.7
|
|
Stress as Measured by the Impact of Events Scale (IES)
Month 1
|
31.0 units on a scale
Interval 29.0 to 33.0
|
29.1 units on a scale
Interval 27.1 to 31.1
|
|
Stress as Measured by the Impact of Events Scale (IES)
Month 3
|
30.3 units on a scale
Interval 28.0 to 32.6
|
28.4 units on a scale
Interval 26.1 to 30.8
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12).
The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).
Outcome measures
| Measure |
Caregiver Control
n=62 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=62 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)
Baseline
|
-0.12 ln[(nmol/L)/hour]
Interval -0.15 to -0.08
|
-0.12 ln[(nmol/L)/hour]
Interval -0.16 to -0.09
|
|
The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)
Month 1
|
-0.10 ln[(nmol/L)/hour]
Interval -0.13 to -0.07
|
-0.12 ln[(nmol/L)/hour]
Interval -0.15 to -0.08
|
|
The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)
Month 3
|
-0.12 ln[(nmol/L)/hour]
Interval -0.15 to -0.1
|
-0.11 ln[(nmol/L)/hour]
Interval -0.14 to -0.09
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15).
The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.
Outcome measures
| Measure |
Caregiver Control
n=58 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=59 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)
Baseline
|
-0.11 ln[(nmol/L)/hour]
Interval -0.14 to -0.09
|
-0.13 ln[(nmol/L)/hour]
Interval -0.15 to -0.1
|
|
The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)
Month 1
|
-0.13 ln[(nmol/L)/hour]
Interval -0.16 to -0.1
|
-0.15 ln[(nmol/L)/hour]
Interval -0.18 to -0.12
|
|
The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)
Month 3
|
-0.13 ln[(nmol/L)/hour]
Interval -0.15 to -0.11
|
-0.17 ln[(nmol/L)/hour]
Interval -0.18 to -0.15
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).
The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.
Outcome measures
| Measure |
Caregiver Control
n=58 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=60 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Area Under the Curve for Salivary Cortisol (AUCc)
Baseline
|
3.85 ln[(nmol/L)*hour]
Interval 3.71 to 3.99
|
3.65 ln[(nmol/L)*hour]
Interval 3.51 to 3.79
|
|
Area Under the Curve for Salivary Cortisol (AUCc)
Month 1
|
3.78 ln[(nmol/L)*hour]
Interval 3.61 to 3.96
|
3.80 ln[(nmol/L)*hour]
Interval 3.62 to 3.98
|
|
Area Under the Curve for Salivary Cortisol (AUCc)
Month 3
|
3.77 ln[(nmol/L)*hour]
Interval 3.55 to 3.99
|
3.68 ln[(nmol/L)*hour]
Interval 3.45 to 3.91
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).
The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.
Outcome measures
| Measure |
Caregiver Control
n=58 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=60 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Area Under the Curve for Salivary DHEA (AUCd)
Baseline
|
1.44 ln[(nmol/L)*hour]
Interval 1.26 to 1.62
|
1.64 ln[(nmol/L)*hour]
Interval 1.46 to 1.81
|
|
Area Under the Curve for Salivary DHEA (AUCd)
Month 1
|
1.52 ln[(nmol/L)*hour]
Interval 1.34 to 1.7
|
1.41 ln[(nmol/L)*hour]
Interval 1.23 to 1.59
|
|
Area Under the Curve for Salivary DHEA (AUCd)
Month 3
|
1.56 ln[(nmol/L)*hour]
Interval 1.37 to 1.74
|
1.35 ln[(nmol/L)*hour]
Interval 1.16 to 1.54
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 1 and 3 post transplantPopulation: Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).
The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).
Outcome measures
| Measure |
Caregiver Control
n=66 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=72 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity
Baseline
|
-1.01 ln(% Lysis/NK+ Cell)
Interval -1.23 to -0.78
|
-1.07 ln(% Lysis/NK+ Cell)
Interval -1.29 to -0.86
|
|
Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity
Month 1
|
-1.09 ln(% Lysis/NK+ Cell)
Interval -1.28 to -0.89
|
-1.17 ln(% Lysis/NK+ Cell)
Interval -1.37 to -0.97
|
|
Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity
Month 3
|
-1.09 ln(% Lysis/NK+ Cell)
Interval -1.32 to -0.86
|
-1.27 ln(% Lysis/NK+ Cell)
Interval -1.49 to -1.04
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6).
Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.
Outcome measures
| Measure |
Caregiver Control
n=67 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=68 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma C-reactive Protein (CRP)
Baseline
|
0.18 ln(mg/L)
Interval -0.16 to 0.51
|
0.27 ln(mg/L)
Interval -0.06 to 0.61
|
|
Plasma C-reactive Protein (CRP)
Month 3
|
0.03 ln(mg/L)
Interval -0.37 to 0.43
|
-0.10 ln(mg/L)
Interval -0.5 to 0.3
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Wilcoxon signed rank t-test
Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.
Outcome measures
| Measure |
Caregiver Control
n=43 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=45 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)
Baseline
|
.39 pg/mL
Standard Deviation .62
|
.39 pg/mL
Standard Deviation .73
|
|
Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)
3 Months
|
.39 pg/mL
Standard Deviation .70
|
.39 pg/mL
Standard Deviation .22
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4).
Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.
Outcome measures
| Measure |
Caregiver Control
n=63 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma Inflammatory Marker Interleukin 6 (IL-6)
Baseline
|
-0.33 ln(pg/mL)
Interval -0.54 to -0.13
|
-0.56 ln(pg/mL)
Interval -0.76 to -0.37
|
|
Plasma Inflammatory Marker Interleukin 6 (IL-6)
Month 3
|
-0.13 ln(pg/mL)
Interval -0.34 to 0.07
|
-0.45 ln(pg/mL)
Interval -0.65 to -0.25
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Wilcoxon signed rank t-test
Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.
Outcome measures
| Measure |
Caregiver Control
n=43 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=45 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma Inflammatory Marker Interleukin 4 (IL-4)
Baseline
|
1.56 pg/mL
Standard Deviation 1.29
|
1.56 pg/mL
Standard Deviation 0.00
|
|
Plasma Inflammatory Marker Interleukin 4 (IL-4)
3 months
|
1.56 pg/mL
Standard Deviation 4.02
|
1.56 pg/mL
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Wilcoxon signed rank t-test
Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.
Outcome measures
| Measure |
Caregiver Control
n=43 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=45 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma Inflammatory Marker Interleukin 10 (IL-10)
Baseline
|
1.72 pg/mL
Standard Deviation 3.50
|
1.60 pg/mL
Standard Deviation 1.19
|
|
Plasma Inflammatory Marker Interleukin 10 (IL-10)
3 months
|
1.60 pg/mL
Standard Deviation 2.69
|
1.60 pg/mL
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant) and 3 post transplantPopulation: Wilcoxon signed rank t-test
Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.
Outcome measures
| Measure |
Caregiver Control
n=43 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
|
Caregiver Intervention
n=45 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
|
|---|---|---|
|
Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)
Baseline
|
4.70 pg/mL
Standard Deviation 5.29
|
4.70 pg/mL
Standard Deviation 2.01
|
|
Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)
3 months
|
4.70 pg/mL
Standard Deviation 5.37
|
4.70 pg/mL
Standard Deviation 2.69
|
Adverse Events
Caregiver Control
Caregiver Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark L. Laudenslager, PhD
University of Colorado Denver
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place