CAREgiver Study for Patients Undergoing HSCT

NCT03210727 | Completed

• 1 other identifier: D17033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Enrollment statistics

  Number enrolled in study divided by number eligible

  Throughout the study, an average of one year

Secondary Outcomes (9)

• 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

Study Arms (1)

single arm

OTHER

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

Interventions

Ready to CARE program BEHAVIORAL

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.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• Under the age of 18 for either caregiver or patient.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kathleen D Lyons, ScD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)..

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: July 25, 2017
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)