Clinical trial NCT03210727: CAREgiver Study for Patients Undergoing HSCT
Official title: A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)..
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Enrollment statistics
timeFrame: Throughout the study, an average of one year
Secondary outcomes:
measure: Retention
timeFrame: Throughout the study, an average of one year
measure: Goal Attainment
timeFrame: Day 30 after stem cell reinfusion
measure: Session Completion
timeFrame: Day 30 after stem cell reinfusion
measure: Caregiver Satisfaction
timeFrame: Day 30 after stem cell reinfusion
measure: Caregiver Self-efficacy
timeFrame: Day 100 after stem cell reinfusion
measure: Caregiver Coping style
timeFrame: Day 100 after stem cell reinfusion
measure: Patient Quality of Life
timeFrame: Day 100 after stem cell reinfusion
measure: Patient symptom burden
timeFrame: Day 100 after stem cell reinfusion
measure: Patient healthcare utilization
timeFrame: Day 100 after stem cell reinfusion
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kathleen D Lyons, ScD
role: PRINCIPAL_INVESTIGATOR
References: