CAREgiver Study for Patients Undergoing HSCT

Study Overview
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Brief Summary
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The investigators will use a single arm design and deliver a new supportive intervention entitled, Ready to Connect, Actively Relax and Exercise (CARE). The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping style, and patient quality of life, symptom burden, and healthcare utilization.

Detailed Description
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During the first phase of this study, the investigators enrolled caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT) into a descriptive study. The investigators used quantitative and qualitative measures to describe the caregivers self-efficacy, distress, and coping style, and solicit their opinions about how to improve our supportive care for caregivers. Informed by those data, the investigators now will study the effectiveness of the supportive intervention. The long-term goal of this research is to develop a pragmatic, replicable intervention that supports caregivers and promotes the health and well-being of the caregiver-HSCT patient dyad.

Official Title
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A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Ready to CARE program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providing informal, unpaid care for a person who is 18 years of age or older and is scheduled to receive an allogeneic or autologous HSCT within the next three months. The caregiver's loved one (patient) undergoing the transplant will be asked to enroll in the study to provide data regarding quality of life and symptom burden and to allow access of the medical record to ascertain healthcare utilization data. (Caregivers will not be excluded from the study if the patient declines to enroll.) Exclusion Criteria: Under the age of 18 for either caregiver or patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: a single arm design will be used to pilot test the Ready to CARE program with 20 caregivers (while also measuring outcomes in the 20 patients receiving HSCT)..
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>This arm will be used to pilot test the Ready to CARE program (with the caregivers) and measure outcomes (in the patients). | Behavioral: Ready to CARE program<br>* The intervention is built upon a model of caregiver well-being that identifies four domains of quality of life: physical, psychological, social, and spiritual well-being. For each domain, there are stressors (i.e., factors that make it hard to be a caregiver) and buffers (i.e., factors that help people be effective caregivers). Our Ready to CARE intervention begins by presenting caregivers with the model in order to generate a profile of personal stressors and buffers. From there, caregivers select from a menu of strategies that can be used to minimize stressors and create buffers in their daily life. The investigators will have six 45-minute sessions with the caregivers that will primarily occur while the patient is admitted for stem cell reinfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment statistics | Number enrolled in study divided by number eligible | Throughout the study, an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | number completing all study assessments divided by number enrolled | Throughout the study, an average of one year | 
| Goal Attainment | average goal attainment score between sessions | Day 30 after stem cell reinfusion | 
| Session Completion | Average number of sessions completed | Day 30 after stem cell reinfusion | 
| Caregiver Satisfaction | Average score on satisfaction survey | Day 30 after stem cell reinfusion | 
| Caregiver Self-efficacy | Average change score on Caregiver Self-efficacy Scale | Day 100 after stem cell reinfusion | 
| Caregiver Coping style | Average change score on Brief Cope | Day 100 after stem cell reinfusion | 
| Patient Quality of Life | Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant | Day 100 after stem cell reinfusion | 
| Patient symptom burden | Average change score on MD Anderson Symptom Inventory | Day 100 after stem cell reinfusion | 
| Patient healthcare utilization | Average number of re-hospitalizations, urgent care or emergency department visits, and telephone calls to bone marrow transplant program | Day 100 after stem cell reinfusion |