Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06709404
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| WFBCCC 98522 | OTHER | Wake Forest Baptist Comprehensive Cancer Center | View |