CAREgiver Study for Patients Undergoing HSCT
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|ClinicalTrials.gov Identifier: NCT03210727|
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Behavioral: Ready to CARE program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
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.
- Enrollment statistics [ Time Frame: Throughout the study, an average of one year ]Number enrolled in study divided by number eligible
- Retention [ Time Frame: Throughout the study, an average of one year ]number completing all study assessments divided by number enrolled
- Goal Attainment [ Time Frame: Day 30 after stem cell reinfusion ]average goal attainment score between sessions
- Session Completion [ Time Frame: Day 30 after stem cell reinfusion ]Average number of sessions completed
- Caregiver Satisfaction [ Time Frame: Day 30 after stem cell reinfusion ]Average score on satisfaction survey
- Caregiver Self-efficacy [ Time Frame: Day 100 after stem cell reinfusion ]Average change score on Caregiver Self-efficacy Scale
- Caregiver Coping style [ Time Frame: Day 100 after stem cell reinfusion ]Average change score on Brief Cope
- Patient Quality of Life [ Time Frame: Day 100 after stem cell reinfusion ]Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant
- Patient symptom burden [ Time Frame: Day 100 after stem cell reinfusion ]Average change score on MD Anderson Symptom Inventory
- 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
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
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Kathleen D Lyons, ScD||Dartmouth-Hitchcock Medical Center|