CAREgiver Study for Patients Undergoing HSCT

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: Ready to CARE program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): August 29, 2018

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: D17033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No