Clinical trial NCT06709404: Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
Official title: Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria

* Primary caregiver of a patient scheduled to receive CS+HIPEC
* Access to a computer or smartphone and must have an email address
* 18 years of age or older
* 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

Primary outcomes:
measure: Percentage of caregivers who participate (Feasibility)
timeFrame: At 1 and 2 years
Secondary outcomes:
measure: Depression - Center for Epidemiologic Studies-Depression Scale (CES-D)
timeFrame: At pre-op, 2 weeks-3 months post-op, and 6-9 months post-op
measure: Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy
timeFrame: At pre-op, 2 weeks-3 months post-op, and 6-9 months post-op
measure: Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form
timeFrame: At post-op, at 6 months and 12 months
measure: Self-efficacy
timeFrame: At pre-op, 2 weeks-3 months post-op, and 6-9 months post-op
measure: Self-reported community resource
timeFrame: At pre-op, 2 weeks-3 months post-op, and 6-9 months post-op
measure: Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC)
timeFrame: At pre-op, 2 weeks, 3 months post-op, 6-9 months post-op, 12-16 months post-op, and 24-28 months post-op
measure: Social support - Medical Outcome Study Social Support Survey (MOS-SSS)
timeFrame: At pre-op, 2 weeks-3 months post-op, 6-9 months post-op, 12-16 months post-op, and 24-28 months post-op
measure: Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE)
timeFrame: At 2 weeks-3 months post-op and 6-9 months post-op
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
References: