Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Funding unavailable
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psycho-educational intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psycho-educational intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Scale scores | 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. | At 2 months |
| System Usability Scale scores | 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 | At 2 months |
| Mean caregiver satisfaction scores | 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. | At the end of each intervention session and end of study evaluation, up to 2 months |
| Percent of enrollment of eligible participants | Feasibility as measured by percent of enrollment of eligible participants | At 2 months |
| Percent of participants completing intervention | Feasibility as measured by intervention completion | At 2 months |
| Retention rate | Feasibility as measured by percent of participants retained in full study (aim: 90% retention at the end of the 2-month intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| NCCN Distress Thermometer scores | Caregiver Distress as measured by NCCN Distress Thermometer scores | At baseline and at 2 months |
| PROMISR Short Form v1.0 - Anxiety | Caregiver Anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-Not meeting inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sara Douglas, PhD, RN | Case Western Reserve University | Principal Investigator |
Not provided
This is a pilot study to only test the intervention so the data would not be useful to participants until a larger study (with control and intervention groups) is completed in the future
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| At 2 months |
| Average time to recruit dyads in months | Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months) | At 2 months |
| Data collection completion rate | Feasibility as measured by completion of data collection across study timepoints | At 2 months |
| At baseline and at 2 months |
| PROMISRv.1.2 - GlobalHealth scores | 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 | At baseline and at 2 months |