Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
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.
Arms & interventions
- OtherTelemedicine
Receive telehealth navigation intervention
- OtherSurvey administration
Ancillary studies
- OtherElectronic health record review
Ancillary studies
- OtherBest Practice
Receive standard caregiving experience
Outcome measures
Primary
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.
Time frame: At 1 and 2 years
Secondary
Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy
Time frame: Up to 2 years
Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy
Time frame: Up to 2 years
Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form
Time frame: Up to 2 years
Self-efficacy
Time frame: Up to 2 years
Self-reported community resource
Time frame: Up to 2 years
Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)
Time frame: Up to 2 years
Social support - Medical Outcome Study Social Support Survey (MOS-SSS)
Time frame: Up to 2 years
Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)
Time frame: Up to 2 years
Eligibility criteria
Study locations (1)
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157