Neoplasms
Conditions
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.
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.
Interventions
BEHAVIORALReady 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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)..
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment statistics | Throughout the study, an average of one year | Number enrolled in study divided by number eligible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment | Day 30 after stem cell reinfusion | average goal attainment score between sessions |
| Session Completion | Day 30 after stem cell reinfusion | Average number of sessions completed |
| Caregiver Satisfaction | Day 30 after stem cell reinfusion | Average score on satisfaction survey |
| Caregiver Self-efficacy | Day 100 after stem cell reinfusion | Average change score on Caregiver Self-efficacy Scale |
| Retention | Throughout the study, an average of one year | number completing all study assessments divided by number enrolled |
| Patient Quality of Life | Day 100 after stem cell reinfusion | Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant |
| Patient symptom burden | Day 100 after stem cell reinfusion | Average change score on MD Anderson Symptom Inventory |
| Patient healthcare utilization | 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 |
| Caregiver Coping style | Day 100 after stem cell reinfusion | Average change score on Brief Cope |
Countries
United States
Outcome results
None listed