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

Hematopoietic/Lymphoid Cancer Clinical Trial

Official title:

Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037568
• Other study ID #: 13-2639
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: December 5, 2017
• Start date: January 2014
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer

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."

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Presbyterian/St. Luke's Medical Center (PSLMC)	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Treatment - Blood/Marrow Transplant	"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant" (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality.	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Primary	Caregiver Distress - Principal Component Analysis	Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Secondary	Perceived Stress Scale	The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Secondary	Center for Epidemiological Studies Depression Scale	"Center for Epidemiological Studies Depression" Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Secondary	Spielberger State-Trait Anxiety Inventory	The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Secondary	Change in Adrenal Activity Over Time	Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. Because hair cortisol were not normally distributed, the data were log transformed.	Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.
Secondary	Change in Caregiver Telomere Length Over Time	Telomere length was assessed as a measure of cellular aging in blood samples from participants. Because telomere length were not normally distributed, the data were log transformed.	Baseline (prior to transplant), 3 months and 6 months after transplant
Secondary	Change in Caregiver Telomerase Activity Over Time	Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes. Because telomerase activity were not normally distributed, the data were log transformed.	Baseline (prior to transplant), 3 months and 6 months after transplant
Secondary	Caregiver Reaction Assessment	The "Caregiver Reaction Assessment" (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.	Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant