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NCT Number: NCT06709404

Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Katie Duckworth, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Other

Receive telehealth navigation intervention

Survey Administration

Other

Ancillary studies

Electronic Health Record Review

Other

Ancillary studies

Best Practice

Other

Receive standard caregiving experience

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

3367165772

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 29, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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