Clinical trial NCT02037568: Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
Official title: Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic/Lymphoid Cancer
Keywords: depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
allogeneic hematopoietic stem cell transplant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-01-16
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
measure: Caregiver Distress - Principal Component Analysis
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
measure: Spielberger State-Trait Anxiety Inventory
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
measure: Change in Adrenal Activity Over Time
timeFrame: Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.
measure: Change in Caregiver Telomere Length Over Time
timeFrame: Baseline (prior to transplant), 3 months and 6 months after transplant
measure: Change in Caregiver Telomerase Activity Over Time
timeFrame: Baseline (prior to transplant), 3 months and 6 months after transplant
measure: Caregiver Reaction Assessment
timeFrame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Presbyterian/St. Luke's Medical Center (PSLMC)
state: Colorado
Study officials:
affiliation: University of Colorado Denver (Anschutz Medical Campus)
name: Mark L Laudenslager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sannes TS, Ranby KW, Yusufov M, Brewer BW, Jacobs JM, Callan S, Ulrich GR, Pensak NA, Natvig C, Laudenslager ML. More often than not, we're in sync: patient and caregiver well-being over time in stem cell transplantation. Health Qual Life Outcomes. 2022 Jan 10;20(1):6. doi: 10.1186/s12955-021-01909-3.
citation: Laudenslager ML, Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Brewer BW, Sannes TS, Kilbourn K, Gutman J, McSweeney P. A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Psychooncology. 2019 Aug;28(8):1614-1623. doi: 10.1002/pon.5126. Epub 2019 May 25.