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Completed

NCT Number: NCT03210727

CAREgiver Study for Patients Undergoing HSCT

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Enrollment statistics

    Time frame: Throughout the study, an average of one year

    Number enrolled in study divided by number eligible

Secondary outcomes

  1. Retention

    Time frame: Throughout the study, an average of one year

    number completing all study assessments divided by number enrolled

  2. Goal Attainment

    Time frame: Day 30 after stem cell reinfusion

    average goal attainment score between sessions

  3. Session Completion

    Time frame: Day 30 after stem cell reinfusion

    Average number of sessions completed

  4. Caregiver Satisfaction

    Time frame: Day 30 after stem cell reinfusion

    Average score on satisfaction survey

  5. Caregiver Self-efficacy

    Time frame: Day 100 after stem cell reinfusion

    Average change score on Caregiver Self-efficacy Scale

  6. Caregiver Coping style

    Time frame: Day 100 after stem cell reinfusion

    Average change score on Brief Cope

  7. Patient Quality of Life

    Time frame: Day 100 after stem cell reinfusion

    Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant

  8. Patient symptom burden

    Time frame: Day 100 after stem cell reinfusion

    Average change score on MD Anderson Symptom Inventory

  9. Patient healthcare utilization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2017
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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