Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Survey administration (Other)
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.
Intervention: Telemedicine (Other)
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.
Intervention: Electronic health record review (Other)
Group 2 (Usual Care)
Participants receive standard caregiving experience on study.
Intervention: Survey administration (Other)
Group 2 (Usual Care)
Participants receive standard caregiving experience on study.
Intervention: Electronic health record review (Other)
Group 2 (Usual Care)
Participants receive standard caregiving experience on study.
Intervention: Best Practice (Other)
Outcomes
Primary Outcomes
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
- 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)
- Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)(Up to 2 years)
- Social support - Medical Outcome Study Social Support Survey (MOS-SSS)(Up to 2 years)
- Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)(Up to 2 years)