Trial Outcomes & Findings for Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress (NCT NCT02037568)
NCT ID: NCT02037568
Last Updated: 2017-12-06
Results Overview
"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant" (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Results posted on
2017-12-06
Participant Flow
Caregivers and their Allo-HSCT patients were recruited consecutively between 3/2014 and 11/2016 during pre-transplant screening admitted for treatment to two transplant programs in the Denver metro area for participation in this study: a university-based NCI-designated Comprehensive Cancer Center and a community-based cancer center.
159 patient-caregiver dyads were consented (318 participants).
Participant milestones
| Measure |
Caregiver Self-Directed (TAU)
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
76
|
|
Overall Study
Month 1.5 (Post Transplantation)
|
79
|
76
|
|
Overall Study
Month 3 (Post Transplantation)
|
66
|
62
|
|
Overall Study
Month 6 (Post Transplantation)
|
63
|
52
|
|
Overall Study
COMPLETED
|
47
|
37
|
|
Overall Study
NOT COMPLETED
|
36
|
39
|
Reasons for withdrawal
| Measure |
Caregiver Self-Directed (TAU)
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
24
|
|
Overall Study
Lost to Follow-up
|
16
|
13
|
|
Overall Study
Screen Failure
|
3
|
1
|
|
Overall Study
Patient did not receive transplant
|
0
|
1
|
Baseline Characteristics
Caregiver information was not available for TAU for the following variable: age (n = 2). PEPRR for the following variables: age (n = 1).
Baseline characteristics by cohort
| Measure |
Caregiver Self-Directed (TAU)
n=83 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 12.8 • n=81 Participants • Caregiver information was not available for TAU for the following variable: age (n = 2). PEPRR for the following variables: age (n = 1).
|
53.6 years
STANDARD_DEVIATION 14.7 • n=75 Participants • Caregiver information was not available for TAU for the following variable: age (n = 2). PEPRR for the following variables: age (n = 1).
|
54.1 years
STANDARD_DEVIATION 13.7 • n=156 Participants • Caregiver information was not available for TAU for the following variable: age (n = 2). PEPRR for the following variables: age (n = 1).
|
|
Sex: Female, Male
Female
|
67 Participants
n=81 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
58 Participants
n=75 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
125 Participants
n=156 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
|
Sex: Female, Male
Male
|
14 Participants
n=81 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
17 Participants
n=75 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
31 Participants
n=156 Participants • Measure Analysis Population Description: Caregiver information was not available for TAU for the following variable: sex (n = 2). PEPRR for the following variables: sex (n = 1).
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=83 Participants
|
6 Participants
n=76 Participants
|
14 Participants
n=159 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=83 Participants
|
65 Participants
n=76 Participants
|
129 Participants
n=159 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=83 Participants
|
5 Participants
n=76 Participants
|
16 Participants
n=159 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=83 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=159 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=83 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=159 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=159 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=83 Participants
|
2 Participants
n=76 Participants
|
2 Participants
n=159 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=83 Participants
|
62 Participants
n=76 Participants
|
130 Participants
n=159 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=83 Participants
|
3 Participants
n=76 Participants
|
6 Participants
n=159 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=83 Participants
|
9 Participants
n=76 Participants
|
20 Participants
n=159 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=83 Participants
|
76 participants
n=76 Participants
|
159 participants
n=159 Participants
|
|
Annual income
< 25,000
|
29 Participants
n=83 Participants
|
21 Participants
n=76 Participants
|
50 Participants
n=159 Participants
|
|
Annual income
25,000-44,999
|
14 Participants
n=83 Participants
|
13 Participants
n=76 Participants
|
27 Participants
n=159 Participants
|
|
Annual income
45,000-64,999
|
13 Participants
n=83 Participants
|
18 Participants
n=76 Participants
|
31 Participants
n=159 Participants
|
|
Annual income
> 65,000
|
13 Participants
n=83 Participants
|
16 Participants
n=76 Participants
|
29 Participants
n=159 Participants
|
|
Annual income
Unknown or Not Reported
|
14 Participants
n=83 Participants
|
8 Participants
n=76 Participants
|
22 Participants
n=159 Participants
|
|
Relationship to patient
Spouse/Civil Partner
|
54 Participants
n=83 Participants
|
48 Participants
n=76 Participants
|
102 Participants
n=159 Participants
|
|
Relationship to patient
Sibling
|
5 Participants
n=83 Participants
|
8 Participants
n=76 Participants
|
13 Participants
n=159 Participants
|
|
Relationship to patient
Parent
|
11 Participants
n=83 Participants
|
9 Participants
n=76 Participants
|
20 Participants
n=159 Participants
|
|
Relationship to patient
Child
|
6 Participants
n=83 Participants
|
3 Participants
n=76 Participants
|
9 Participants
n=159 Participants
|
|
Relationship to patient
Other
|
0 Participants
n=83 Participants
|
7 Participants
n=76 Participants
|
7 Participants
n=159 Participants
|
|
Relationship to patient
Unknown or Not Reported
|
7 Participants
n=83 Participants
|
1 Participants
n=76 Participants
|
8 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
Full-time
|
30 Participants
n=83 Participants
|
35 Participants
n=76 Participants
|
65 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
Part-time
|
15 Participants
n=83 Participants
|
12 Participants
n=76 Participants
|
27 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
Unemployed
|
9 Participants
n=83 Participants
|
7 Participants
n=76 Participants
|
16 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
On leave
|
1 Participants
n=83 Participants
|
1 Participants
n=76 Participants
|
2 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
Retired
|
20 Participants
n=83 Participants
|
20 Participants
n=76 Participants
|
40 Participants
n=159 Participants
|
|
Employment Status (Before Caregiving)
Unknown or Not Reported
|
8 Participants
n=83 Participants
|
1 Participants
n=76 Participants
|
9 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
Full-time
|
15 Participants
n=83 Participants
|
18 Participants
n=76 Participants
|
33 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
Part-time
|
15 Participants
n=83 Participants
|
14 Participants
n=76 Participants
|
29 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
Unemployed
|
9 Participants
n=83 Participants
|
12 Participants
n=76 Participants
|
21 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
On leave
|
15 Participants
n=83 Participants
|
13 Participants
n=76 Participants
|
28 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
Retired
|
20 Participants
n=83 Participants
|
17 Participants
n=76 Participants
|
37 Participants
n=159 Participants
|
|
Employment Status (During Caregiving)
Unknown or Not Reported
|
9 Participants
n=83 Participants
|
2 Participants
n=76 Participants
|
11 Participants
n=159 Participants
|
|
Patient Age, Continuous
|
54.6 years
STANDARD_DEVIATION 14.2 • n=83 Participants
|
51.9 years
STANDARD_DEVIATION 15.3 • n=76 Participants
|
53.3 years
STANDARD_DEVIATION 14.8 • n=159 Participants
|
|
Patient Sex: Female, Male
Female
|
29 Participants
n=83 Participants
|
27 Participants
n=76 Participants
|
56 Participants
n=159 Participants
|
|
Patient Sex: Female, Male
Male
|
54 Participants
n=83 Participants
|
49 Participants
n=76 Participants
|
103 Participants
n=159 Participants
|
|
Patient Diagnosis
Leukemia
|
53 Participants
n=83 Participants
|
44 Participants
n=76 Participants
|
97 Participants
n=159 Participants
|
|
Patient Diagnosis
Lymphoma
|
11 Participants
n=83 Participants
|
10 Participants
n=76 Participants
|
21 Participants
n=159 Participants
|
|
Patient Diagnosis
MDS/MPS
|
16 Participants
n=83 Participants
|
19 Participants
n=76 Participants
|
35 Participants
n=159 Participants
|
|
Patient Diagnosis
Other (MM, SAA)
|
3 Participants
n=83 Participants
|
3 Participants
n=76 Participants
|
6 Participants
n=159 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Patient Control group missing responses (n = 14). Caregiver Intervention group: missing responses (n = 6).
"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant" (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=69 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=70 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
Baseline
|
97.7 units on a scale
Interval 93.3 to 102.2
|
98.1 units on a scale
Interval 93.6 to 102.5
|
|
Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
Month 1.5
|
95.7 units on a scale
Interval 90.4 to 100.9
|
95.8 units on a scale
Interval 90.3 to 101.2
|
|
Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
Month 3
|
101.5 units on a scale
Interval 96.2 to 106.8
|
100.1 units on a scale
Interval 94.5 to 105.8
|
|
Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
Month 6
|
100.9 units on a scale
Interval 94.5 to 107.3
|
101.8 units on a scale
Interval 94.2 to 109.4
|
PRIMARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).
Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Caregiver Distress - Principal Component Analysis
Baseline
|
-0.09 units on a scale
Interval -0.31 to 0.14
|
0.07 units on a scale
Interval -0.16 to 0.3
|
|
Caregiver Distress - Principal Component Analysis
Month 1.5
|
0.02 units on a scale
Interval -0.22 to 0.26
|
-0.06 units on a scale
Interval -0.31 to 0.19
|
|
Caregiver Distress - Principal Component Analysis
Month 3
|
0.05 units on a scale
Interval -0.21 to 0.32
|
0.0 units on a scale
Interval -0.27 to 0.28
|
|
Caregiver Distress - Principal Component Analysis
Month 6
|
0.14 units on a scale
Interval -0.11 to 0.39
|
-0.2 units on a scale
Interval -0.47 to 0.07
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).
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. The total score range is 0-56. A higher score indicates greater stress.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Perceived Stress Scale
Baseline
|
24.2 units on a scale
Interval 22.3 to 26.1
|
25.5 units on a scale
Interval 23.5 to 27.4
|
|
Perceived Stress Scale
Month 1.5
|
23.0 units on a scale
Interval 21.2 to 24.8
|
22.9 units on a scale
Interval 21.1 to 24.8
|
|
Perceived Stress Scale
Month 3
|
21.3 units on a scale
Interval 19.2 to 23.5
|
22.4 units on a scale
Interval 20.1 to 24.6
|
|
Perceived Stress Scale
Month 6
|
21.9 units on a scale
Interval 19.9 to 24.0
|
20.5 units on a scale
Interval 18.3 to 22.7
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).
"Center for Epidemiological Studies Depression" Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Center for Epidemiological Studies Depression Scale
Baseline
|
20.0 units on a scale
Interval 18.5 to 21.4
|
20.5 units on a scale
Interval 19.0 to 22.0
|
|
Center for Epidemiological Studies Depression Scale
Month 1.5
|
19.6 units on a scale
Interval 18.3 to 21.0
|
18.3 units on a scale
Interval 16.9 to 19.7
|
|
Center for Epidemiological Studies Depression Scale
Month 3
|
20.0 units on a scale
Interval 18.3 to 21.7
|
17.8 units on a scale
Interval 16.0 to 19.7
|
|
Center for Epidemiological Studies Depression Scale
Month 6
|
21.3 units on a scale
Interval 19.4 to 23.2
|
18.0 units on a scale
Interval 16.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).
The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Spielberger State-Trait Anxiety Inventory
Baseline
|
39.6 units on a scale
Interval 36.7 to 42.5
|
41.6 units on a scale
Interval 38.6 to 44.6
|
|
Spielberger State-Trait Anxiety Inventory
Month 1.5
|
38.4 units on a scale
Interval 35.4 to 41.3
|
39.6 units on a scale
Interval 36.5 to 42.6
|
|
Spielberger State-Trait Anxiety Inventory
Month 3
|
39.2 units on a scale
Interval 35.9 to 42.6
|
39.3 units on a scale
Interval 35.8 to 42.8
|
|
Spielberger State-Trait Anxiety Inventory
Month 6
|
39.1 units on a scale
Interval 35.8 to 42.4
|
35.7 units on a scale
Interval 32.2 to 39.2
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.Population: Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).
Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. Because hair cortisol were not normally distributed, the data were log transformed.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=75 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=74 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Change in Adrenal Activity Over Time
Baseline
|
1.93 log (pg/mg)
Interval 1.68 to 2.2
|
2.14 log (pg/mg)
Interval 1.88 to 2.4
|
|
Change in Adrenal Activity Over Time
Month 3
|
1.98 log (pg/mg)
Interval 1.71 to 2.26
|
2.18 log (pg/mg)
Interval 1.89 to 2.46
|
|
Change in Adrenal Activity Over Time
Month 6
|
2.19 log (pg/mg)
Interval 1.89 to 2.5
|
2.14 log (pg/mg)
Interval 1.8 to 2.47
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).
Telomere length was assessed as a measure of cellular aging in blood samples from participants. Because telomere length were not normally distributed, the data were log transformed.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=75 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=74 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Change in Caregiver Telomere Length Over Time
Baseline
|
0.03 log (T/S ratio)
Interval -0.02 to 0.08
|
0.0 log (T/S ratio)
Interval -0.05 to 0.05
|
|
Change in Caregiver Telomere Length Over Time
Month 3
|
0.03 log (T/S ratio)
Interval -0.02 to 0.08
|
0.0 log (T/S ratio)
Interval -0.05 to 0.06
|
|
Change in Caregiver Telomere Length Over Time
Month 6
|
0.03 log (T/S ratio)
Interval -0.02 to 0.09
|
0.03 log (T/S ratio)
Interval -0.03 to 0.09
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).
Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes. Because telomerase activity were not normally distributed, the data were log transformed.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=75 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=74 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Change in Caregiver Telomerase Activity Over Time
Baseline
|
1.7 log (enzyme unit)
Interval 1.55 to 1.84
|
1.7 log (enzyme unit)
Interval 1.56 to 1.85
|
|
Change in Caregiver Telomerase Activity Over Time
Month 3
|
1.69 log (enzyme unit)
Interval 1.57 to 1.82
|
1.73 log (enzyme unit)
Interval 1.6 to 1.87
|
|
Change in Caregiver Telomerase Activity Over Time
Month 6
|
1.76 log (enzyme unit)
Interval 1.55 to 1.97
|
1.71 log (enzyme unit)
Interval 1.47 to 1.95
|
SECONDARY outcome
Timeframe: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplantPopulation: Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).
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 includes 5 subscales. The scores of each scale are summed to compute a total score. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.
Outcome measures
| Measure |
Caregiver Self-Directed (TAU)
n=76 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
|
Caregiver Intervention (PEPRR 2.0)
n=73 Participants
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
fPER: Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors
|
|---|---|---|
|
Caregiver Reaction Assessment
Baseline
|
10.4 units on a scale
Interval 9.9 to 11.0
|
10.3 units on a scale
Interval 9.7 to 10.9
|
|
Caregiver Reaction Assessment
Month 1.5
|
10.8 units on a scale
Interval 10.1 to 11.4
|
10.9 units on a scale
Interval 10.3 to 11.6
|
|
Caregiver Reaction Assessment
Month 3
|
10.8 units on a scale
Interval 10.0 to 11.5
|
10.9 units on a scale
Interval 10.2 to 11.7
|
|
Caregiver Reaction Assessment
Month 6
|
10.5 units on a scale
Interval 9.7 to 11.4
|
10.5 units on a scale
Interval 9.6 to 11.3
|
Adverse Events
Caregiver Self-Directed (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregiver Intervention (PEPRR 2.0)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Phone: 303-724-9277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place