NCT06709404

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Mar 2028

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

November 25, 2024

Last Update Submit

April 9, 2026

Conditions

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility)

    Feasibility will be measured by the number of caregivers who complete the Center for Epidemiologic Studies-Depression Scale (CES-D). The 95% confidence interval for the observed rates will be calculated.

    At 1 and 2 years

Secondary Outcomes (8)

  • Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy

    Up to 2 years

  • Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy

    Up to 2 years

  • Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form

    Up to 2 years

  • Self-efficacy

    Up to 2 years

  • Self-reported community resource

    Up to 2 years

  • +3 more secondary outcomes

Study Arms (2)

Group 1 (Telehealth intervention)

EXPERIMENTAL

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.

Other: TelemedicineOther: Survey administrationOther: Electronic health record review

Group 2 (Usual Care)

ACTIVE COMPARATOR

Participants receive standard caregiving experience on study.

Other: Survey administrationOther: Electronic health record reviewOther: Best Practice

Interventions

TelemedicineOTHER

Receive telehealth navigation intervention

Group 1 (Telehealth intervention)
Survey administrationOTHER

Ancillary studies

Group 1 (Telehealth intervention)Group 2 (Usual Care)
Electronic health record reviewOTHER

Ancillary studies

Group 1 (Telehealth intervention)Group 2 (Usual Care)
Best PracticeOTHER

Receive standard caregiving experience

Group 2 (Usual Care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • \- Patient declines access to their medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

TelemedicinePractice Guidelines as Topic

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationGuidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Katie Duckworth

    Wake Forest Baptist Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3367165772Emily.Teal@advocatehealth.org

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

November 25, 2024

First Posted

November 29, 2024

Study Start

January 31, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)