Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06709404

Telehealth Support to Reduce Distress and Financial Stress in Caregivers of Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Led by Wake Forest University Health Sciences · Updated on 2026-04-13

50

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether identifying resources for primary caregivers can help reduce financial stress, depression, and improve quality of life and coping ability. Caregivers of patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) face significant depressive symptoms and financial challenges that differ from those experienced by patients. The study focuses on whether telehealth support can increase caregivers' awareness of helpful resources and better support their needs throughout the caregiving journey. Participants are randomly assigned to one of two groups. The intervention group receives a telehealth navigation session lasting about one hour, conducted 1 to 4 weeks before the patient's surgery, which may include referrals to specific caregiving resources. The comparison group receives the standard caregiving experience without the telehealth intervention. After the intervention, all participants are followed up at 3, 6, 12, and 24 months to assess ongoing effects. Throughout the study, caregivers complete surveys and assessments to measure depression using the Center for Epidemiologic Studies-Depression Scale (CES-D), financial distress, self-efficacy in managing treatment costs, satisfaction with care, community resource use, quality of life, social support, and treatment satisfaction. Electronic health records are also reviewed as part of ancillary studies. The study tracks caregiver outcomes at 1 and 2 years to understand the telehealth intervention's feasibility and impact over time.

CONDITIONS

Official Title

Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary caregiver of a patient scheduled to receive CS+HIPEC at Atrium Health Wake Forest Baptist Comprehensive Cancer Center
  • Access to a computer or smartphone and must have an email address
  • 18 years of age or older at the time of consent
  • Ability to understand and willingness to provide written informed consent
  • Ability to read and write English
Not Eligible

You will not qualify if you...

  • Patient declines access to their medical record

AI-Screening

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3
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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

S

Study Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

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Telehealth Support to Reduce Distress and Financial Stress in Caregivers of Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy | DecenTrialz