Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

April 9, 2026 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility)
Time Frame: At 1 and 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katie Duckworth, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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