Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

Overview

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.

Full Title of Study: “A Pilot Study to Evaluate the Feasibility of an Intervention for Caregivers of Patients Who Have Recently Undergone HSCT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2021

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

  • Behavioral: Psycho-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

Arms, Groups and Cohorts

  • Experimental: Psycho-educational intervention
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Acceptability Scale scores
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: At 2 months
    • Feasibility as measured by percent of enrollment of eligible participants
  • Percent of participants completing intervention
    • Time Frame: At 2 months
    • Feasibility as measured by intervention completion
  • Retention rate
    • Time Frame: 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
    • Time Frame: At 2 months
    • Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months)
  • Data collection completion rate
    • Time Frame: At 2 months
    • Feasibility as measured by completion of data collection across study timepoints

Secondary Measures

  • NCCN Distress Thermometer scores
    • Time Frame: At baseline and at 2 months
    • Caregiver Distress as measured by NCCN Distress Thermometer scores
  • PROMISR Short Form v1.0 – Anxiety
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

    Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Case Comprehensive Cancer Center
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Sara Douglas, PhD, RN, Principal Investigator, Case Western Reserve University
    • Overall Contact(s)
      • Sara Douglas, PhD, RN, 1 216-368-0702, sld4@case.edu

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