Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy

NCT04390542 | Withdrawn

• 1 other identifier: CASE8Z20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Cancer

Outcome Measures

Primary Outcomes (8)

• Time to identify and recruit dyads in months

  Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)

  2 months post-hospital discharge, an average of 2 months

• Accrual rates

  Feasibility, as measured by accrual rates of eligible participants

  2 months post-hospital discharge, an average of 2 months

• Retention rate

  Feasibility, as measured by retention rate

  2 months post-hospital discharge, an average of 2 months

• Data collection completion rate

  Feasibility as measured by completion of data collection across study timepoints

  2 months post-hospital discharge, an average of 2 months

• 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.

  2 months post-hospital discharge, an average of 2 months

• 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.

  2 months post-hospital discharge, an average of 2 months

• 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.

  2 months post-hospital discharge, an average of 2 months

• 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.

  2 months post-hospital discharge, an average of 2 months

Secondary Outcomes (3)

• Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores

  Baseline, hospital discharge, 2 months post hospital discharge

• Caregiver Healthcare Related Quality Of Life (HRQOL)

  Baseline, hospital discharge, 2 months post hospital discharge

• Distress as measured by the the NCCN distress thermometer

  Baseline, hospital discharge, 2 months post hospital discharge

Study Arms (2)

Psychoeducation intervention

EXPERIMENTAL

Psychoeducatoinal intervention

Behavioral: Psychoeducation

Usual care

NO INTERVENTION

Information from healthcare providers

Interventions

Psychoeducation BEHAVIORAL

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

Psychoeducation intervention

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sara Douglas, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: June 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share