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Clinical Trials/NCT03210727
NCT03210727
Completed
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country20 target enrollmentJuly 25, 2017
ConditionsNeoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Enrollment statistics
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2017
End Date
August 29, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen Lyons

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Enrollment statistics

Time Frame: Throughout the study, an average of one year

Number enrolled in study divided by number eligible

Secondary Outcomes

  • Retention(Throughout the study, an average of one year)
  • Goal Attainment(Day 30 after stem cell reinfusion)
  • Session Completion(Day 30 after stem cell reinfusion)
  • Caregiver Satisfaction(Day 30 after stem cell reinfusion)
  • Caregiver Self-efficacy(Day 100 after stem cell reinfusion)
  • Caregiver Coping style(Day 100 after stem cell reinfusion)
  • Patient Quality of Life(Day 100 after stem cell reinfusion)
  • Patient symptom burden(Day 100 after stem cell reinfusion)
  • Patient healthcare utilization(Day 100 after stem cell reinfusion)

Study Sites (1)

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