Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

NCT04639700 | Withdrawn

• 1 other identifier: CASE14Z20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Caregiver Anxiety; Caregiver Distress; Caregiver Health Related QOL

Keywords

Hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• NCCN Distress Thermometer scores

  At baseline and at 2 months

• PROMISR Short Form v1.0 - Anxiety

  At baseline and at 2 months

• PROMISRv.1.2 - GlobalHealth scores

  At baseline and at 2 months

Study Arms (1)

Psycho-educational intervention

EXPERIMENTAL

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

Interventions

Psycho-educational intervention BEHAVIORAL

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

Psycho-educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Officials

• Sara Douglas, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share