Recruiting

Telehealth Intervention

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06709404

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telemedicine

Survey administration

Electronic health record review

Best Practice

Study Details

Brief summary:

This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06709404

Start date

Jan 31, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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
  • The ability to understand and willingness to provide written informed consent
  • The ability to read and write English

Exclusion Criteria

\- Patient declines access to their medical record

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1 (Telehealth intervention)

Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.

active comparator: Group 2 (Usual Care)

Participants receive standard caregiving experience on study.

Interventions

Telemedicine

Receive telehealth navigation intervention

Survey administration

Ancillary studies

Electronic health record review

Ancillary studies

Best Practice

Receive standard caregiving experience

Primary outcome measure

  • Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility) [ Time Frame: At 1 and 2 years ]

Central Contacts and Locations

Central contacts

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Katie Duckworth, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-13.