Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06709404
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telemedicine — OTHER
    Receive telehealth navigation intervention
  • Survey administration — OTHER
    Ancillary studies
  • Electronic health record review — OTHER
    Ancillary studies
  • Best Practice — OTHER
    Receive standard caregiving experience

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: Group 2 (Usual Care)
    Participants receive standard caregiving experience on study.

Primary Outcome Measure

Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility) [ Time Frame: At 1 and 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Katie Duckworth, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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