Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02037568
First received: January 14, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Hematopoietic/Lymphoid Cancer
Behavioral: fPER

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 450
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)
Arms Assigned Interventions
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.
Behavioral: 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 such as coping with the "new normal."
Other Names:
  • Other Names:
  • "fone" PsychoEducation and Relaxation
  • fPER

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • - DISEASE CHARACTERISTICS (Meets all of the following criteria):

    • Patient undergoing allogeneic hematopoietic stem cell transplant (HSCT)
    • Primary caregiver of a BMT patient for 50% of the time
  • PATIENT CHARACTERISTICS:

    • Able to read and speak English
    • Has telephone access
  • CAREGIVER CHARACTERISTICS:

    • Able to read and speak English
    • Willingness to use a Smartphone
    • No serious medical condition likely to influence cortisol assessment in their hair
    • Alcohol consumption limited to < 2 drinks/day
    • Least 18 years of age

Exclusion Criteria:

  • PRIOR CONCURRENT THERAPY:

    • No history of a psychiatric illness unrelated to the HSCT within the past 18 months
    • No steroid medications (caregiver)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037568

Contacts
Contact: Mark L Laudenslager, PhD 303-724-9276 mark.laudenslager@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Ben W Brewer, PsyD    720-848-1161    benjamin.brewer@ucdenver.edu   
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         
Sponsors and Collaborators
University of Colorado, Denver
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Mark L Laudenslager, PhD University of Colorado Denver (Anschutz Medical Campus)
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02037568     History of Changes
Other Study ID Numbers: 13-2639
Study First Received: January 14, 2014
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
allogeneic hematopoietic stem cell transplant

ClinicalTrials.gov processed this record on September 16, 2014