Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemedicine, Survey administration, Electronic health record review, Best Practice.
- Who it may be relevant to
- Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Overview
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.
Interventions
- Other Telemedicine
Receive telehealth navigation intervention - Other Survey administration
Ancillary studies - Other Electronic health record review
Ancillary studies - Other Best Practice
Receive standard caregiving experience
Primary outcome measures
- Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility) [Time frame: At 1 and 2 years]
Secondary outcome measures (8)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT06709404 · IRB00110615 · P30CA012197 · WFBCCC 98522