Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Electronic health record review; Other: Telemedicine; Other: Survey administration; Other: Best Practice

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 3367165772; Email: Emily.Teal@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Comprehensive Cancer Center
      • Principal Investigator: Katie Duckworth, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Electronic health record review; Ancillary studies; Other: Telemedicine; Receive telehealth navigation intervention; Other: Survey administration; Ancillary studies
Active Comparator: Group 2 (Usual Care); Participants receive standard caregiving experience on study.	Other: Electronic health record review; Ancillary studies; Other: Survey administration; Ancillary studies; Other: Best Practice; Receive standard caregiving experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy	Depression will be based on the proportion of caregivers screening in with scores at or above 16, the score that indicates possible depression. These data will be dichotomized into depressed (yes/no) status and analyzed using a repeated measures logistic regression to see if the rate of depression changes. The model will include a time group interaction, and if that test is not significant, the term will be removed and the model refit to assess differences between groups and estimate change in CES-D score. The CES-D is a 20-item self-report measure developed to screen for depressive disorders. A score of ≥ 16 has been used as the cut-off score with higher scores indicating significant depressive symptoms. Caregivers who score ≥16 will be documented.	Up to 2 years
Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy	Will be measured using the adapted Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy item for caregivers. Repeated measures longitudinal models will be used to detect changes in these measures. Initially, the model will include a time group interaction, and if that test is not significant, the term will be removed and the model refit to assess differences between groups and estimate change in financial distress scores. Lower scores indicate greater financial distress; higher scores indicate better financial well being. Scores range from 0 to 44.	Up to 2 years
Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form	The results will be summarized and reported. This item is given once to the caregivers; these results will help to make changes to the intervention in future studies. Satisfaction scores will be compared between the 2 arms using an independent t-test.	Up to 2 years
Self-efficacy	The General Self Efficacy Scale is a ten-item scale with Likert-type items created to "assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Scores range from 10 to 40 with higher scores indicating greater self-efficacy	Up to 2 years
Self-reported community resource	Will be used among intervention and standard of care caregivers and will be reported as a proportion using these resources. The corresponding 95% confidence interval will also be reported. These rates can be compared between groups using a two-proportion Z-test.	Up to 2 years
Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)	Will be measured using the Caregiver Quality of Life Index-Cancer scale for caregivers. Will be evaluated using repeated measures regression, with estimates of scores at the 5 time points reported and tested for differences across the 5 collection times. The CQOLC scale consists of 35 five-point Likert-type items. Scores range from 0-140 (Good 0-45, fair 46-90, poor 91-140). The CQOLC is made up of four subscales: Burden, Disruptiveness, Positive adaptation, and Financial concerns.	Up to 2 years
Social support - Medical Outcome Study Social Support Survey (MOS-SSS)	The MOS-SSS contains 19 functional support items hypothesized to measure five dimensions of social support: 1) emotional support, 2) informational support, 3) tangible support, 4) positive social interaction, and 5) affectionate support. Responses are on a five-point Likert-type scale ranging from 'none of the time' to 'all of the time.' Score range is 0-20. Total score is calculated by adding up the responses for each item. A higher score indicates a greater level of perceived social support.	Up to 2 years
Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)	The FAMCARE scale is a 20-item self-report questionnaire that measures how satisfied family caregivers are with the healthcare provided to the patient and themselves. The scale uses a Likert scale ranging from 1 to 5, with 1 being "very satisfied" and 5 being "very dissatisfied". The FAMCARE scale can be scored as mean scores or percentages. The percentage score ranges from 20 to 100, with higher scores indicating greater caregiver satisfaction.	Up to 2 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katie Duckworth, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress; Neoplasms; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Quality of Health Care; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Practice Guidelines as Topic; Telemedicine
• Other Study ID Numbers: IRB00110615; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC 98522 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No