Caregiver Anxiety, Caregiver Distress, Caregiver Health Related QOL
Conditions
Keywords
Hematopoietic stem cell transplantation
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.
Interventions
BEHAVIORALPsycho-educational intervention
Participant will be sent a baseline survey, and will then be contacted by the interventionist to complete 4 sessions, which feature the following areas: Session 1: Identifying CG Needs for Information & Support, Communication with Healthcare Team Session 2: Communication with Patient and Family Session 3: Self-care: Emotional & Spiritual Needs, Self-care: Physical Needs Session 4: Re-Assessing Needs, Planning for the future
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data collection completion rate | At 2 months | Feasibility as measured by completion of data collection across study timepoints |
| Percent of participants completing intervention | At 2 months | Feasibility as measured by intervention completion |
| 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) |
| 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) |
| 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. |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| NCCN Distress Thermometer scores | At baseline and at 2 months | Caregiver Distress as measured by NCCN Distress Thermometer scores |
Outcome results
None listed