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CAREgiver Study for Patients Undergoing HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210727
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Kathleen Lyons, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Ready to CARE program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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)..
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
single arm
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
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 Outcome Measures :
  1. Enrollment statistics [ Time Frame: Throughout the study, an average of one year ]
    Number enrolled in study divided by number eligible


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210727


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Kathleen D Lyons, ScD Dartmouth-Hitchcock Medical Center
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Responsible Party: Kathleen Lyons, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03210727    
Other Study ID Numbers: D17033
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No