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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Withdrawn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
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 12, 2020
    Last Updated
    July 14, 2021
    Sponsor
    Case Comprehensive Cancer Center
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    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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