Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate the Feasibility of an Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

Conditions
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Caregiver Anxiety, Caregiver Distress, Caregiver Health Related QOL

Intervention / Treatment
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* Behavioral: Psycho-educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psycho-educational intervention<br>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 | Behavioral: Psycho-educational intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic stem cell transplantation