Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 6:49 PM
Study NCT ID:
NCT02037568
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Specific Aims
* Create a Community Advisory Board (CAB) consisting of allogeneic HSCT patients, caregivers, blood cancer oncologists, support staff and study investigators to provide input.
* Assess patient Quality of Life (QOL) following an allogeneic HSCT using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as the primary patient outcome. Patients whose caregivers receive "fone" PsychoEducation and Relaxation (fPER) will have improved QOL compared to caregivers assigned to treatment as usual (TAU).
* Test the impact of fPER on a caregiver composite distress score (encompasses depression, anxiety, and stress) as the primary caregiver outcome. Caregivers receiving fPER will have reduced distress.
* Assess biomarkers of allostatic load in patients prior to transplant and caregivers during the transplant process using novel biomarkers (hair cortisol and telomeres). fPER will be associated with reduced allostatic load in caregivers compared to TAU. Patient hair cortisol collected only before transplant will relate to QOL at intake.
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.
* Group I (treatment as usual \[TAU\]): Subjects randomized to TAU will be encouraged to participate in available support programs at their respective centers which are very similar between sites and include individual counseling as well as support groups. Due to the impact of our prior intervention on caregiver distress, we will provide each caregiver randomized to TAU a workbook prepared for someone to use without inclusion of one-on-one sessions with a therapist.
* Group II (PsychoEducation and Relaxation \[fPER\]): Caregivers will participate in the fPER intervention prior to transplant. The fPER consists of 10 sessions to include 4 weekly 60-minute sessions followed by 4 biweekly 60-minute sessions and two additional sessions between day 100 and 6 months post-transplant. Each fPER session will be devoted to a separate topic with the goal of assisting the caregiver in the development and application of stress-management coping skills including learning problem-solving skills, identifying cognitive distortions, application of relaxation techniques, use of the emWave2, coping skills training, effective use of social support, and establishing appropriate goals. All caregivers in fPER will be provided a Caregiver Workbook that includes information about the session topics and homework assignments. fPER sessions will be delivered either at the clinic during patient visits or via video chat. fPER will also include incorporation of Smartphone technology to make the interventionist available by video chat.
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.
* Create a Community Advisory Board (CAB) consisting of allogeneic HSCT patients, caregivers, blood cancer oncologists, support staff and study investigators to provide input.
* Assess patient Quality of Life (QOL) following an allogeneic HSCT using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as the primary patient outcome. Patients whose caregivers receive "fone" PsychoEducation and Relaxation (fPER) will have improved QOL compared to caregivers assigned to treatment as usual (TAU).
* Test the impact of fPER on a caregiver composite distress score (encompasses depression, anxiety, and stress) as the primary caregiver outcome. Caregivers receiving fPER will have reduced distress.
* Assess biomarkers of allostatic load in patients prior to transplant and caregivers during the transplant process using novel biomarkers (hair cortisol and telomeres). fPER will be associated with reduced allostatic load in caregivers compared to TAU. Patient hair cortisol collected only before transplant will relate to QOL at intake.
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.
* Group I (treatment as usual \[TAU\]): Subjects randomized to TAU will be encouraged to participate in available support programs at their respective centers which are very similar between sites and include individual counseling as well as support groups. Due to the impact of our prior intervention on caregiver distress, we will provide each caregiver randomized to TAU a workbook prepared for someone to use without inclusion of one-on-one sessions with a therapist.
* Group II (PsychoEducation and Relaxation \[fPER\]): Caregivers will participate in the fPER intervention prior to transplant. The fPER consists of 10 sessions to include 4 weekly 60-minute sessions followed by 4 biweekly 60-minute sessions and two additional sessions between day 100 and 6 months post-transplant. Each fPER session will be devoted to a separate topic with the goal of assisting the caregiver in the development and application of stress-management coping skills including learning problem-solving skills, identifying cognitive distortions, application of relaxation techniques, use of the emWave2, coping skills training, effective use of social support, and establishing appropriate goals. All caregivers in fPER will be provided a Caregiver Workbook that includes information about the session topics and homework assignments. fPER sessions will be delivered either at the clinic during patient visits or via video chat. fPER will also include incorporation of Smartphone technology to make the interventionist available by video chat.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: