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

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.

Inclusion Criteria:

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

- Patient undergoing allogeneic hematopoietic stem cell transplant (HSCT)

- Caregiver: the person in the patient's life who is primarily responsible for care
decisions, emotionally invested in the patient's care, provides instrumental care
such as transportation, and available if randomized to the fPER group to
participate in the majority of intervention sessions

- 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

- At 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)