A Pilot Study to Evaluate the Feasibility of an Intervention for Caregivers of Patients Who Have Recently Undergone HSCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Retention rate
Study Overview
Brief Summary
The purpose of this study is to find out if providing support to caregivers of patients who have recently had a HSCT is possible and helpful.
Detailed Description
This study will test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention. All participants will receive the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist. In addition, the all participants will receive 4 individual sessions with an interventionist.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •An adult family or friend of a patient who has been discharged from the hospital in the past 1-2 weeks after receiving HSCT
- •Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT
- •Has English as their primary language
Exclusion Criteria
- •Not meeting inclusion criteria
Arms & Interventions
Psycho-educational intervention
All participants will receive receive 4 individual sessions with an interventionist in addition to the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist
Intervention: Psycho-educational intervention (Behavioral)
Outcomes
Primary Outcomes
Retention rate
Time Frame: At 2 months
Feasibility as measured by percent of participants retained in full study (aim: 90% retention at the end of the 2-month intervention)
Mean caregiver satisfaction scores
Time Frame: At the end of each intervention session and end of study evaluation, up to 2 months
Caregiver Satisfaction scores as measured by Likert Scale. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores \>7 will be considered acceptable. Mean and standard deviation will be reported.
Percent of enrollment of eligible participants
Time Frame: At 2 months
Feasibility as measured by percent of enrollment of eligible participants
Percent of participants completing intervention
Time Frame: At 2 months
Feasibility as measured by intervention completion
Acceptability Scale scores
Time Frame: At 2 months
Caregiver Acceptability as measured by Acceptability Scale scores. Overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.
Data collection completion rate
Time Frame: At 2 months
Feasibility as measured by completion of data collection across study timepoints
System Usability Scale scores
Time Frame: At 2 months
Caregiver Usability as measured by the System Usability Scale. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores \> 68 considered to be above average usability
Average time to recruit dyads in months
Time Frame: At 2 months
Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months)
Secondary Outcomes
- NCCN Distress Thermometer scores(At baseline and at 2 months)
- PROMISR Short Form v1.0 - Anxiety(At baseline and at 2 months)
- PROMISRv.1.2 - GlobalHealth scores(At baseline and at 2 months)