A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona

NCT05418387 | Withdrawn DMC

• 1 other identifier: 35185
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project will develop and pilot test social support intervention for an underserved population, Hispanics in Arizona, who have high rates of kidney and liver cancer to improve health equity. The investigators will incorporate caregivers (family members) and other individuals in a patient's social network in survivorship, who are especially critical to quality cancer care. Caregivers provide more than half the care to cancer survivors and are often instrumental in facilitating the survivor to receive the care needed and adhere to guidelines. Through this project, the investigators will be able to leverage the resources of the Cancer Heath Equity Research Center (e.g., community outreach) to develop an intervention that has the potential for scalability and reach and recruit a sufficient sample across the target catchment area (including rural participants who may live near the US-Mexico border).

Conditions

Renal Cell Carcinoma; Hepatocellular Carcinoma

Keywords

Kidney cancer; Renal cell carcinoma; Hepatocellular carcinoma; Social support; Social network; Caregiver; Hispanics

Outcome Measures

Primary Outcomes (5)

• Screening and enrollment figures

  Screening and enrollment figures will be assessed as the number of patients who are screened and enrolled per month, respectively.

  Screening and enrollment

• Study retention

  Retention will be assessed as the number of patients who complete the 6-month intervention activities and assessment in both the usual care control and intervention group.

  6-months post enrollment (end of the intervention)

• Completeness of data collection

  Completeness of data collection will be assessed as the proportion of randomized patients who complete each study assessment, including any follow-up assessments.

  9-months post enrollment

• Participant adherence to the intervention

  The proportion of patients randomized to the intervention group who complete each of the 7 telephone sessions.

  6-months post enrollment (end of intervention)

• Acceptability of the intervention

  Patients' overall experience and satisfaction with the intervention, navigator's assessment of the overall impact of the intervention on secondary outcomes.

  9-months post enrollment

Secondary Outcomes (3)

• Mean and median time to treatment initiation in the control vs. intervention group

  6-months post enrollment (end of intervention) and 12-months

• Proportion of patients who attend a follow-up imaging assessment after their surgery with hepatologists or urologists in control vs. intervention group

  6-months post enrollment (end of intervention), 12-months, and 18-months

• Proportion of patients who attend a scheduled appointment after their surgery with hepatologists or urologists in control vs. intervention group

  6-months post enrollment (end of intervention), 12-months, and 18-months

Study Arms (2)

Group A

EXPERIMENTAL

Patients randomized to receive the Social Support Network intervention

Behavioral: Social Support Network Intervention

Patient Navigation

ACTIVE COMPARATOR

Patients randomized to receive Usual Care (patient navigation)

Behavioral: Control (Patient Navigation Service)

Interventions

Social Support Network Intervention BEHAVIORAL

The navigator will provide basic patient navigation services and Supportive Health Education to the patient/caregiver dyads in the patient's preferred language using the Support Network Workbook. The intervention will consist of 7 telephone sessions. There will be 2 sessions in the first month and one session per month after the first month (6 months total). Coaching and guiding techniques rather than lectures will be used applying dyads' specific social support network information. Each session will be about 30 minutes long.

Group A

Control (Patient Navigation Service) BEHAVIORAL

The patient navigator will provide basic patient navigation services consisting of health care barriers/social needs assessment, referral to social workers (if eligible) and support groups for patients and caregivers, and transportation assistance without Supportive Health Education. Patient/caregiver dyads in the control group will be contacted at 3- and 6-months post-enrollment and asked about their experience receiving treatment, any challenges they encountered or are currently facing, and the care support they received from family members, friends, CHWs, and health care providers.

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be adult Hispanic patients (age 18 or older) who have diagnosis of primary kidney and liver cancer through imaging assessment with CT or MRI at BUMC.
• For liver cancer, we will include only HCC patients.

You may not qualify if:

• Patients with a small kidney mass (clinical T1a) who are undergoing active surveillance and patients with metastatic kidney or liver cancer will be excluded.

Sponsors & Collaborators

• University of Arizona: lead
• American Cancer Society, Inc.: collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Ken Batai, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 14, 2022
• Study Start: September 30, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share