Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Caregiver Distress; Caregiver Anxiety; Caregiver Health Related QOL
• Intervention / Treatment: Behavioral: Psycho-educational intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Sara Douglas, PhD, RN, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hematopoietic stem cell transplantation
• Other Study ID Numbers: CASE14Z20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No