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Clinical Trial 21081

Cancer Type: Immunotherapy
Study Type: Supportive Care
NCT#:

Phase: N/A
Prinicipal Investigator: Kedar Kirtane

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or 1-800-679-0775 Learn More
Overview

Study Title

Assessing Distress in Family Caregivers of Patients Receiving Cellular Therapies

Summary

The purpose of the study is to assess the psychosocial characteristics of patients undergoing cellular immunotherapies and their caregivers across time, including patient/caregiver distress, resilience, coping, caregiver burden and preparedness.

Objective

This project will examine the psychosocial and physical well-being amongst patients receiving cellular immunotherapy and their primary caregivers in a prospective longitudinal, observational, mixed-methods study. More specifically, we will collect data on (1) patient and caregiver distress (i.e., anxiety, depression) (2) patient and caregiver resilience and coping skills, and (3) caregiver burden and preparedness, using patient-reported outcome instruments and validated measures. We will also conduct semi-structured interviews to capture other patient and caregiver needs and obtain feedback on a potential caregiver support intervention based on the BMT model. Data on patient/caregiver distress and intervention feedback will be presented to MCC stakeholders (e.g., clinic staff, social work, etc.) for additional feedback to assist with intervention development, including timing and workflow. Ultimately, we hope to better understand patient and caregiver distress and how it changes over time and begin to develop an intervention to address these psychosocial needs. We aim to: Aim 1. Describe the psychosocial characteristics of patients undergoing cellular immunotherapies and their caregivers across time, including patient/caregiver distress, resilience, coping; caregiver burden, preparedness. Aim 2. Obtain qualitative data on the needs of patients undergoing cellular immunotherapies and their family caregivers and obtain feedback on potential intervention components.

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria: Patient eligibility criteria:

  • Slated to receive cellular immunotherapy product within 30 days of consent
  • Seen for at least one appointment at Moffitt Cancer Center
  • Enrolled in the Moffitt Cancer Center Total Cancer Care protocol
  • 18 years of age or older
  • Able to communicate in English
  • Able to provide informed consent Caregiver eligibility criteria:
  • Self-identifies as current primary caregiver of an eligible patient (even if the patient does not participate)
  • Intends to stay at Moffitt Cancer Center during treatment
  • Intends to be the primary caregiver for 30 days after cellular immunotherapy
  • 18 years of age or older
  • Able to communicate in English
  • Able to provide informed consent

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