Intervention for Caregivers of Patients Who Have Recently Undergone HSCT
- Conditions
- Caregiver AnxietyCaregiver Health Related QOLCaregiver Distress
- Interventions
- Behavioral: Psycho-educational intervention
- Registration Number
- NCT04639700
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
-Not meeting inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psycho-educational intervention 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
- Primary Outcome Measures
Name Time Method Mean caregiver satisfaction scores 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 At 2 months Feasibility as measured by percent of enrollment of eligible participants
Percent of participants completing intervention At 2 months Feasibility as measured by intervention completion
Acceptability Scale scores 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.
Retention rate 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)
Data collection completion rate At 2 months Feasibility as measured by completion of data collection across study timepoints
System Usability Scale scores 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 At 2 months Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months)
- Secondary Outcome Measures
Name Time Method NCCN Distress Thermometer scores At baseline and at 2 months Caregiver Distress as measured by NCCN Distress Thermometer scores
PROMISR Short Form v1.0 - Anxiety At baseline and at 2 months Caregiver Anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety
PROMISRv.1.2 - GlobalHealth scores At baseline and at 2 months Caregiver Health Related Quality of Life as measured by PROMISRv.1.2-GlobalHealth scores. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes