Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
Condition: Hematopoietic/Lymphoid Cancer
Study type: Interventional

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.
    

Intervention name(s): fPER
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Other Names:; "fone" PsychoEducation and Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology; allogeneic hematopoietic stem cell transplant