Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
Primary Purpose
Blood Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Blood Cancer
Eligibility Criteria
Inclusion Criteria:
Patients:
- Has a diagnosis of blood cancer (leukemia, lymphoma, myeloma, MDS, MPN, CML, CMML) and is scheduled to undergo HCST or CAR T-cell therapy at SCC
- Will receive HSCT or CAR T-cell therapy and follow-up care from a medical oncologist at University Hospitals Seidman Cancer Center (SCC)
- Has English as their primary language
- Provides consent for his/her own treatment and procedures
- Has an identified caregiver (per SCC-HSCT and CAR T-cell therapy protocol) who will be involved in the patient's care post-HCST or CAR T-cell therapy
Caregivers
- An adult family or friend (at least 18 years old) of a patient scheduled to receive HSCT or CAR T-cell therapy at SCC
- Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT or CAR T-cell therapy
- Has English as their primary language
- Is capable of providing informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychoeducation intervention
Usual care
Arm Description
Psychoeducatoinal intervention
Information from healthcare providers
Outcomes
Primary Outcome Measures
Time to identify and recruit dyads in months
Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)
Accrual rates
Feasibility, as measured by accrual rates of eligible participants
Retention rate
Feasibility, as measured by retention rate
Data collection completion rate
Feasibility as measured by completion of data collection across study timepoints
Average acceptability scale scores
Acceptability, as measured by average acceptability scale scores, with 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.
Average System Usability Scale scores
Usability, as measured by average System Usability Scale scores. 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
Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. 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 to describe subjects' overall satisfaction with the intervention reported.
End-of-study caregiver satisfaction scores
End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction.
Secondary Outcome Measures
Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores
Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety.
Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Caregiver Healthcare Related Quality Of Life (HRQOL)
Caregiver HRQOL, evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes.
Distress as measured by the the NCCN distress thermometer
Distress as measured by the NCCN distress thermometer. Thermometer scores range from 0 to 10, with higher scores indicating worse distress.
Prior to administration of the distress thermometer measure, each caregiver will be asked if they are experiencing distress related to Covid-19 (yes/no). The distress thermometer asking them to rate their distress in the past week including today. The Covid-19 variable will be included as a covariate in the analyses.
Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Full Information
NCT ID
NCT04390542
First Posted
May 12, 2020
Last Updated
July 14, 2021
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04390542
Brief Title
Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
Official Title
A Pilot Study Evaluating Feasibility, Acceptability, Usability, Satisfaction and Preliminary Efficacy of an Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding unavailable
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.
Detailed Description
This is a two-group, randomized pilot study to test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention, as compared to a usual care (information from healthcare providers) control group, on caregiver outcomes. The control and intervention groups will receive the standard University Hospitals Seidman Cancer Center (SCC) binder of relevant information regarding care of the patient undergoing HSCT or CAR T-cell therapy. This information will be given to the caregiver by the health care provider. In addition, the intervention group will receive 6 individual sessions with an interventionist during all phases of HSCT or CAR T-cell therapy. The independent variable is group assignment.
The primary objective of this study is to explore the feasibility and acceptability of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.
The secondary objective of this study is to explore the usability, satisfaction and preliminary efficacy of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducation intervention
Arm Type
Experimental
Arm Description
Psychoeducatoinal intervention
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Information from healthcare providers
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
6 sessions (in-person, videoconference, or phone delivery per the caregiver's choice) between the interventionist and caregivers. Topics covered in sessions include:
Session 1: Communication, Support, Self Care, Symptom Management
Sessions 2-4: Communication, Symptom Management, Support
Sessions 5-6: Self-Care, Symptom Management, Communication, Support, Future Planning
Primary Outcome Measure Information:
Title
Time to identify and recruit dyads in months
Description
Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Accrual rates
Description
Feasibility, as measured by accrual rates of eligible participants
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Retention rate
Description
Feasibility, as measured by retention rate
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Data collection completion rate
Description
Feasibility as measured by completion of data collection across study timepoints
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Average acceptability scale scores
Description
Acceptability, as measured by average acceptability scale scores, with 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.
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Average System Usability Scale scores
Description
Usability, as measured by average System Usability Scale scores. 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.
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
Mean caregiver satisfaction
Description
Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. 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 to describe subjects' overall satisfaction with the intervention reported.
Time Frame
2 months post-hospital discharge, an average of 2 months
Title
End-of-study caregiver satisfaction scores
Description
End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction.
Time Frame
2 months post-hospital discharge, an average of 2 months
Secondary Outcome Measure Information:
Title
Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores
Description
Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety.
Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Time Frame
Baseline, hospital discharge, 2 months post hospital discharge
Title
Caregiver Healthcare Related Quality Of Life (HRQOL)
Description
Caregiver HRQOL, evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes.
Time Frame
Baseline, hospital discharge, 2 months post hospital discharge
Title
Distress as measured by the the NCCN distress thermometer
Description
Distress as measured by the NCCN distress thermometer. Thermometer scores range from 0 to 10, with higher scores indicating worse distress.
Prior to administration of the distress thermometer measure, each caregiver will be asked if they are experiencing distress related to Covid-19 (yes/no). The distress thermometer asking them to rate their distress in the past week including today. The Covid-19 variable will be included as a covariate in the analyses.
Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender
Time Frame
Baseline, hospital discharge, 2 months post hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients:
Has a diagnosis of blood cancer (leukemia, lymphoma, myeloma, MDS, MPN, CML, CMML) and is scheduled to undergo HCST or CAR T-cell therapy at SCC
Will receive HSCT or CAR T-cell therapy and follow-up care from a medical oncologist at University Hospitals Seidman Cancer Center (SCC)
Has English as their primary language
Provides consent for his/her own treatment and procedures
Has an identified caregiver (per SCC-HSCT and CAR T-cell therapy protocol) who will be involved in the patient's care post-HCST or CAR T-cell therapy
Caregivers
An adult family or friend (at least 18 years old) of a patient scheduled to receive HSCT or CAR T-cell therapy at SCC
Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT or CAR T-cell therapy
Has English as their primary language
Is capable of providing informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Douglas, PhD, RN
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pilot study
Learn more about this trial
Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
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