CAREgiver Study for Patients Undergoing HSCT

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210727
• Other study ID #: D17033
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: September 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment statistics	Number enrolled in study divided by number eligible	Throughout the study, an average of one year
Secondary	Retention	number completing all study assessments divided by number enrolled	Throughout the study, an average of one year
Secondary	Goal Attainment	average goal attainment score between sessions	Day 30 after stem cell reinfusion
Secondary	Session Completion	Average number of sessions completed	Day 30 after stem cell reinfusion
Secondary	Caregiver Satisfaction	Average score on satisfaction survey	Day 30 after stem cell reinfusion
Secondary	Caregiver Self-efficacy	Average change score on Caregiver Self-efficacy Scale	Day 100 after stem cell reinfusion
Secondary	Caregiver Coping style	Average change score on Brief Cope	Day 100 after stem cell reinfusion
Secondary	Patient Quality of Life	Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant	Day 100 after stem cell reinfusion
Secondary	Patient symptom burden	Average change score on MD Anderson Symptom Inventory	Day 100 after stem cell reinfusion
Secondary	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