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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management psychoeducation will be expected to obtain a new set of coping skills that will allow them to better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected that improving caregiver status will improve patient quality of life.
Specific Aims
OUTLINE: Caregivers are randomized to 1 of 2 groups.
All patients and caregivers, regardless of randomization, are informed of what to expect during the transplant process and how to locate available support resources within each program. Patients and caregivers are given information that is specific to their involvement in the transplantation process and recovery phase.
Caregivers and patients undergo psychosocial assessments prior to randomization, and at 6 weeks, 3 months and 6 months after transplant (anchored to the day of transplant as day 0). At each phase, patients and caregivers will complete the same battery of questionnaires that includes the Center for Epidemiological Studies-Depression scale (CES-D), the perceived stress scale (PSS), and the State-Trait Anxiety Inventory (STAI). Additionally the patient will complete the FACT-BMT each time while the caregiver completes the Caregiver Reaction Assessment (CRA) and Carer Support Needs Assessment Tool (CSNAT). The patient and the caregiver will additionally complete a demographic questionnaire that includes questions regarding age, diagnosis, income, and other standard questions regarding nutrition, health behaviors, and health services utilization. At study completion, an exit questionnaire will address each subject's evaluation of the study and the group in which they were assigned.
Blood and hair samples from caregivers will be collected every three months: baseline (patient and caregiver), 3 (caregiver) and 6 (patient and caregiver) months post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver Self-Directed | No Intervention | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook. | |
| Caregiver Intervention | Experimental | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fPER | Behavioral | 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 such as coping with the "new normal." |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Treatment - Blood/Marrow Transplant | "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. | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
| Caregiver Distress - Principal Component Analysis | 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. | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | 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. | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
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Inclusion Criteria:
DISEASE CHARACTERISTICS (Meets all of the following criteria):
PATIENT CHARACTERISTICS:
CAREGIVER CHARACTERISTICS:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark L Laudenslager, PhD | University of Colorado Denver (Anschutz Medical Campus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Presbyterian/St. Luke's Medical Center (PSLMC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35012566 | Derived | Sannes TS, Ranby KW, Yusufov M, Brewer BW, Jacobs JM, Callan S, Ulrich GR, Pensak NA, Natvig C, Laudenslager ML. More often than not, we're in sync: patient and caregiver well-being over time in stem cell transplantation. Health Qual Life Outcomes. 2022 Jan 10;20(1):6. doi: 10.1186/s12955-021-01909-3. | |
| 31127974 | Derived |
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159 patient-caregiver dyads were consented (318 participants).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver Self-Directed (TAU) | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver Self-Directed (TAU) | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook. |
| BG001 | Caregiver Intervention (PEPRR 2.0) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregiver information was not available for TAU for the following variable: age (n = 2). PEPRR for the following variables: age (n = 1). |
| 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 | Functional Assessment of Cancer Treatment - Blood/Marrow Transplant | "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. | Patient Control group missing responses (n = 14). Caregiver Intervention group: missing responses (n = 6). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
3 years, 3 months
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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 Self-Directed (TAU) | Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark L. Laudenslager, PhD | University of Colorado Denver | 303-724-9277 | biel@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2016 | Sep 1, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2016 | Sep 1, 2017 | Prot_SAP_001.pdf |
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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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|
|
| Center for Epidemiological Studies Depression Scale |
"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. |
| Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
| Spielberger State-Trait Anxiety Inventory | 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). | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
| Change in Adrenal Activity Over Time | 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. | Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant. |
| Change in Caregiver Telomere Length Over Time | 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. | Baseline (prior to transplant), 3 months and 6 months after transplant |
| Change in Caregiver Telomerase Activity Over Time | 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. | Baseline (prior to transplant), 3 months and 6 months after transplant |
| Caregiver Reaction Assessment | 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. | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
| Denver |
| Colorado |
| 80218 |
| United States |
| Laudenslager ML, Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Brewer BW, Sannes TS, Kilbourn K, Gutman J, McSweeney P. A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Psychooncology. 2019 Aug;28(8):1614-1623. doi: 10.1002/pon.5126. Epub 2019 May 25. |
| Screen Failure |
|
| Patient did not receive transplant |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Annual income | Count of Participants | Participants |
|
| Relationship to patient | Count of Participants | Participants |
|
| Employment Status (Before Caregiving) | Count of Participants | Participants |
|
| Employment Status (During Caregiving) | Count of Participants | Participants |
|
| Patient Age, Continuous | Mean | Standard Deviation | years |
|
| Patient Sex: Female, Male | Count of Participants | Participants |
|
| Patient Diagnosis | Abbreviations: MDS, myelodysplastic syndrome; MPS, myeloproliferative syndrome; MM, multiple myeloma; SAA, severe aplastic anemia. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| Primary | Caregiver Distress - Principal Component Analysis | 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. | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Perceived Stress Scale | 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. | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Center for Epidemiological Studies Depression Scale | "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. | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Spielberger State-Trait Anxiety Inventory | 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). | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Change in Adrenal Activity Over Time | 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. | Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2). | Posted | Least Squares Mean | 95% Confidence Interval | log (pg/mg) | Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant. |
|
|
|
|
| Secondary | Change in Caregiver Telomere Length Over Time | 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. | Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2). | Posted | Least Squares Mean | 95% Confidence Interval | log (T/S ratio) | Baseline (prior to transplant), 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Change in Caregiver Telomerase Activity Over Time | 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. | Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2). | Posted | Least Squares Mean | 95% Confidence Interval | log (enzyme unit) | Baseline (prior to transplant), 3 months and 6 months after transplant |
|
|
|
|
| Secondary | Caregiver Reaction Assessment | 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. | Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant |
|
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | 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 | 0 | 76 | 0 | 76 | 0 | 76 |
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| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 45,000-64,999 |
|
| > 65,000 |
|
| Unknown or Not Reported |
|
| Parent |
|
| Child |
|
| Other |
|
| Unknown or Not Reported |
|
| Unemployed |
|
| On leave |
|
| Retired |
|
| Unknown or Not Reported |
|
| Unemployed |
|
| On leave |
|
| Retired |
|
| Unknown or Not Reported |
|
| MDS/MPS |
|
| Other (MM, SAA) |
|
| Month 3 |
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| Month 6 |
|
| Month 3 |
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| Month 6 |
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| Month 3 |
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| Month 6 |
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| Month 3 |
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| Month 6 |
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| Month 6 |
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| Month 6 |
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| Month 6 |
|
| Month 3 |
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| Month 6 |
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