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

NCT ID: NCT02037568

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-09-30

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.

Conditions

Hematopoietic/Lymphoid Cancer

Keywords

depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology; allogeneic hematopoietic stem cell transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Caregiver Self-Directed

Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

fPER

Intervention Type: BEHAVIORAL

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."

Interventions

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."

Intervention Type: BEHAVIORAL

Other Intervention Names

Other Names: "fone" PsychoEducation and Relaxation

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark L Laudenslager, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver (Anschutz Medical Campus)

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Presbyterian/St. Luke's Medical Center (PSLMC)

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35012566 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31127974 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-2639

Identifier Type: -

Identifier Source: org_study_id