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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA126971-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: A stress management intervention may be more effective than usual care in improving quality of life in caregivers of patients undergoing bone marrow transplant.
PURPOSE: This randomized phase III trial is studying a stress management intervention for caregivers of patients undergoing bone marrow transplant.
Specific Aims
OUTLINE: Caregivers are randomized to 1 of 2 groups.
Caregivers and patients undergo psychosocial assessments at approximately 1-3 months prior to randomization and transplantation and again at 1, 3, 6, and 12 months after transplantation. Caregivers also complete questionnaires to assess their stress (PSS, CRA, and IES), mood (POMS, CES-D, and STAI), sleep (PSQI), and health (SF-36).
Caregivers undergo blood and saliva sample collection at baseline and periodically during study for biomarker analysis (e.g., neuroendocrine and immune markers). Caregivers wear an activity watch (actimeter) during each saliva sample collection period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver Control | No Intervention | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care. | |
| Caregiver Intervention | Experimental | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), which included one-on-one psychoeducation, stress management intervention, with paced respiration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paced respiration as part of PEPRR | Device | The FDA approved RESPeRATE™ is the size of a portable compact disk (CD) player with a visual display, an elastic belt-type respiratory sensor, and a set of headphones. During a relaxation session, the device analyzes respiratory pattern of the subject and creates a melody of pleasant tones selected by the subject (one for inhalation and one for exhalation). The subjects can observe a cartoon figure on the screen of the device that indicates their inhalation and exhalation. The subject synchronizes their breathing to these tones as the exhalation tone is gradually increased in duration with a target of less than 10 breaths/minute. Subjects were encouraged to use RESPeRATE 3-5 times a week for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Physiological - Cortisol Awakening Response (CAR) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
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Inclusion Criteria:
DISEASE CHARACTERISTICS (Meets all of the following criteria):
PATIENT CHARACTERISTICS:
Exclusion Criteria:
- PRIOR CONCURRENT THERAPY:
• No concurrent steroid medications (caregiver)
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| Name | Affiliation | Role |
|---|---|---|
| Mark Laudenslager, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado | 80045 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23440998 | Background | Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Kilbourn K, Spradley J, Grzywa-Cobb R, Philips S, McSweeney P, Laudenslager ML. Elevated peri-transplant distress in caregivers of allogeneic blood or marrow transplant patients. Psychooncology. 2013 Sep;22(9):2064-70. doi: 10.1002/pon.3259. Epub 2013 Feb 25. | |
| 25961767 | Result | Laudenslager ML, Simoneau TL, Kilbourn K, Natvig C, Philips S, Spradley J, Benitez P, McSweeney P, Mikulich-Gilbertson SK. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant. 2015 Aug;50(8):1110-8. doi: 10.1038/bmt.2015.104. Epub 2015 May 11. |
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149 patient-caregiver dyads were consented (298 participants) and 148 dyads were randomized. 1 dyad (2 participants) did not meet the inclusion criteria.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver Control | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver Control | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care. |
| BG001 | Caregiver Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS) | 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. | Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregiver Control | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark L. Laudenslager, PhD | University of Colorado Denver | 303-724-9279 | biel@ucdenver.edu |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
|
| PEPRR | Behavioral | PEPRR consist of 8 sessions, each lasting approximately 60min. The first 4 sessions are weekly, followed by biweekly mtgs for the remaining 4 sessions. Sessions begin the week that the patient receives the transfusion of donor cells. Session 1-4 are conducted at the hospital where the patients receive their transplant. Once discharged from the hospital, sessions will be conducted at the outpatient BMT clinic to coincide with patients' post-transplant visits. Sessions are devoted to a separate topic with the goal of assisting the caregiver in development & application of various stress-mgmt techniques such as effective problem-solving, identifying & challenging cognitive distortions, relaxation techniques, coping skills training, effective use of social support & goal setting. |
|
|
| State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI) | 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). | Baseline (prior to transplant), 1 and 3 post transplant |
| Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Stress as Measured by the Impact of Events Scale (IES) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC) | 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). | Baseline (prior to transplant), 1 and 3 post transplant |
| The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Area Under the Curve for Salivary Cortisol (AUCc) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Area Under the Curve for Salivary DHEA (AUCd) | 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. | Baseline (prior to transplant), 1 and 3 post transplant |
| Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity | 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). | Baseline (prior to transplant), 1 and 3 post transplant |
| Plasma C-reactive Protein (CRP) | 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. | Baseline (prior to transplant) and 3 post transplant |
| Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta) | Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology. | Baseline (prior to transplant) and 3 post transplant |
| Plasma Inflammatory Marker Interleukin 6 (IL-6) | Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays. | Baseline (prior to transplant) and 3 post transplant |
| Plasma Inflammatory Marker Interleukin 4 (IL-4) | Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology. | Baseline (prior to transplant) and 3 post transplant |
| Plasma Inflammatory Marker Interleukin 10 (IL-10) | Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology. | Baseline (prior to transplant) and 3 post transplant |
| Plasma Inflammatory Marker Tumor Necrosis Factor (TNF) | Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology. | Baseline (prior to transplant) and 3 post transplant |
| Presbyterian/St. Luke's Medical Center (PSLMC) - Denver Midtown |
| Denver |
| Colorado |
| 80218 |
| United States |
| 25478136 | Result | Ouseph R, Croy C, Natvig C, Simoneau T, Laudenslager ML. Decreased mental health care utilization following a psychosocial intervention in caregivers of hematopoietic stem cell transplant patients. Ment Illn. 2014 Mar 25;6(1):5120. doi: 10.4081/mi.2014.5120. eCollection 2014 Mar 4. |
| Patient did not receive transplant |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | For Caregiver Control gender information, participant did not reported their gender (n = 1). | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Annual income | Income in dollars | Number | participants |
|
| Relationship to patient | Number | participants |
|
| Employment Status (Before Caregiving) | Number | participants |
|
| Employment Status (During Caregiving) | Number | participants |
|
| 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. |
|
|
|
| Primary | Physiological - Cortisol Awakening Response (CAR) | 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. | Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15). | Posted | Mean | 95% Confidence Interval | ln(nmol/L) | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD) | 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. | Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI) | 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). | Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS) | 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. | Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA) | 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. | Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score | 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. | Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M) | 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. | Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P) | 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. | Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Stress as Measured by the Impact of Events Scale (IES) | 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. | Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC) | 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). | Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12). | Posted | Mean | 95% Confidence Interval | ln[(nmol/L)/hour] | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA) | 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. | Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15). | Posted | Mean | 95% Confidence Interval | ln[(nmol/L)/hour] | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Area Under the Curve for Salivary Cortisol (AUCc) | 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. | Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14). | Posted | Mean | 95% Confidence Interval | ln[(nmol/L)*hour] | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Area Under the Curve for Salivary DHEA (AUCd) | 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. | Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14). | Posted | Mean | 95% Confidence Interval | ln[(nmol/L)*hour] | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity | 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). | Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2). | Posted | Mean | 95% Confidence Interval | ln(% Lysis/NK+ Cell) | Baseline (prior to transplant), 1 and 3 post transplant |
|
|
|
|
| Secondary | Plasma C-reactive Protein (CRP) | 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. | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6). | Posted | Mean | 95% Confidence Interval | ln(mg/L) | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| Secondary | Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta) | Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology. | Wilcoxon signed rank t-test | Posted | Median | Standard Deviation | pg/mL | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| Secondary | Plasma Inflammatory Marker Interleukin 6 (IL-6) | Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays. | Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4). | Posted | Mean | 95% Confidence Interval | ln(pg/mL) | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| Secondary | Plasma Inflammatory Marker Interleukin 4 (IL-4) | Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology. | Wilcoxon signed rank t-test | Posted | Median | Standard Deviation | pg/mL | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| Secondary | Plasma Inflammatory Marker Interleukin 10 (IL-10) | Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology. | Wilcoxon signed rank t-test | Posted | Median | Standard Deviation | pg/mL | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| Secondary | Plasma Inflammatory Marker Tumor Necrosis Factor (TNF) | Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology. | Wilcoxon signed rank t-test | Posted | Median | Standard Deviation | pg/mL | Baseline (prior to transplant) and 3 post transplant |
|
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | 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. | 0 | 74 | 0 | 74 |
Not provided
Not provided
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| Month 3 |
|
| .33 |
P-values represent separate wilcoxon paired sample signed rank test. |
| 2-Sided |
| No |
| Superiority or Other |
| 1.00 |
P-values represent separate wilcoxon paired sample signed rank test. |
| 2-Sided |
| No |
| Superiority or Other |
| .72 |
P-values represent separate wilcoxon paired sample signed rank test. |
| 2-Sided |
| No |
| Superiority or Other |
| .72 |
P-values represent separate wilcoxon paired sample signed rank test. |
| 2-Sided |
| No |
| Superiority or Other |