Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

Caregiver Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04639700
• Other study ID #: CASE14Z20
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: November 2021

Study information

• Verified date: May 2021
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Anxiety
• Caregiver Distress
• Caregiver Health Related QOL

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Percent of enrollment of eligible participants	Feasibility as measured by percent of enrollment of eligible participants	At 2 months
Primary	Percent of participants completing intervention	Feasibility as measured by intervention completion	At 2 months
Primary	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
Primary	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
Primary	Data collection completion rate	Feasibility as measured by completion of data collection across study timepoints	At 2 months
Secondary	NCCN Distress Thermometer scores	Caregiver Distress as measured by NCCN Distress Thermometer scores	At baseline and at 2 months
Secondary	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
Secondary	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