CAREgiver Study for Patients Undergoing HSCT

Not Applicable

Completed

• Conditions: Neoplasms
• Interventions: Behavioral: Ready to CARE program

• Registration Number: NCT03210727
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-07-25
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Ready to CARE program	This arm will be used to pilot test the Ready to CARE program (with the caregivers) and measure outcomes (in the patients).

Primary Outcome Measures

Name	Time	Method
Enrollment statistics	Throughout the study, an average of one year	Number enrolled in study divided by number eligible

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States