Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

NCT ID: NCT06709404

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the feasibility of a telehealth navigation intervention for CS+HIPEC caregivers.

SECONDARY OBJECTIVES:

I. To assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers.

II. To compare financial distress in intervention caregivers as compared to standard of care caregivers.

III. To compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers.

IV. To compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants.

V. To compare self-reported community resource use among intervention and standard of care caregivers.

VI. To compare the quality of life over time in intervention caregivers as compared to standard of care caregivers.

VII. To compare social support over time in intervention caregivers as compared to standard of care caregivers.

VIII. To compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: 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.

GROUP II: Participants receive standard caregiving experience on study.

After completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: OTHER

Receive telehealth navigation intervention

Survey administration

Intervention Type: OTHER

Ancillary studies

Electronic health record review

Intervention Type: OTHER

Ancillary studies

Group 2 (Usual Care)

Participants receive standard caregiving experience on study.

Group Type: ACTIVE_COMPARATOR

Survey administration

Intervention Type: OTHER

Ancillary studies

Electronic health record review

Intervention Type: OTHER

Ancillary studies

Best Practice

Intervention Type: OTHER

Receive standard caregiving experience

Interventions

Telemedicine

Receive telehealth navigation intervention

Intervention Type: OTHER

Survey administration

Ancillary studies

Intervention Type: OTHER

Electronic health record review

Ancillary studies

Intervention Type: OTHER

Best Practice

Receive standard caregiving experience

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

ahumbert@wakehealth.edu

3367136912

Other Identifiers

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WFBCCC 98522

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00110615

Identifier Type: -

Identifier Source: org_study_id