CAREgiver Study for Patients Undergoing HSCT

NCT ID: NCT03210727

Last Updated: 2018-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-08-29

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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single arm

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

Group Type OTHER

Ready to CARE program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Lyons

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen D Lyons, ScD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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D17033

Identifier Type: -

Identifier Source: org_study_id

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