Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence|
- Change in Patient quality of life over time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: No ]The total score on the Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT) is a well validated measure of patient quality of life.
- Change in Caregiver Distress over time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: No ]A composite score is created from a principal component analysis (PCA) that incorporates caregiver PSS, CESD, and STAI similar to our prior studies.
- Change in Perceived stress Over Time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: No ]The Perceived Stress Scale (PSS) is a well validated 14 item measure of self perceived loss of control.
- Change in Depression over time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: Yes ]Center for Epidemiological Studies Depression Scale is a well validated 20 item scale measuring symptoms. Study psychologists will be notified if any subject scores 16 and over for follow up.
- Change in Anxiety over time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: No ]The 40 item Spielberger State-Trait Anxiety Inventory will assess anxiety in subjects. It is a well validated measure of subject anxiety.
- Change in adrenal activity over time [ Time Frame: Baseline (prior to transplant), 3 months (caregvier only), and 6 months after transplant in caregivers. ] [ Designated as safety issue: No ]Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis.
- Change in caregiver telomere length over time [ Time Frame: Baseline (prior to transplant), 3 months and 6 months after transplant ] [ Designated as safety issue: No ]Telomere length will be assessed as a measure of cellular aging.
- Change in caregiver telomerase activity over time [ Time Frame: Baseline (prior to transplant), 3 months and 6 months after transplant ] [ Designated as safety issue: No ]Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes.
- Change in caregiver burden over time [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ] [ Designated as safety issue: No ]The 24 item caregiver reaction assessment (CRA) will assess caregiver burden.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
No Intervention: Caregiver Self-Directed
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
Experimental: Caregiver Intervention
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
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."
- 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 QOL following an allogeneic HSCT using the FACT-BMT as the primary patient outcome. Patients whose caregivers receive fPER will have improved QOL compared to caregivers assigned to 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 regard 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 (caregiver) months post-transplant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02037568
|Contact: Mark L Laudenslager, PhDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Ben W Brewer, PsyD 720-848-1161 email@example.com|
|Sub-Investigator: Ben Brewer, PsyD|
|Presbyterian/St. Luke's Medical Center (PSLMC)||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Teri Simoneau, PhD 720-754-4850 Teri.Simoneau@HealthONEcares.com|
|Sub-Investigator: Terese L Simoneau, PhD|
|Principal Investigator:||Mark L Laudenslager, PhD||University of Colorado Denver (Anschutz Medical Campus)|