Clinical trial NCT05418387: A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
Official title: A Pilot Social Network and Support Intervention to Improve Kidney and Liver Cancer Treatment Among Hispanics in Arizona
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Cell Carcinoma
Hepatocellular Carcinoma
Keywords: Kidney cancer
Renal cell carcinoma
Hepatocellular carcinoma
Social support
Social network
Caregiver
Hispanics
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: The goals of this 6-month patient navigator implemented telephone-based social support intervention are to assess 1) feasibility of a full-scale intervention in Hispanic kidney and liver cancer patients and 2) the effect of intervention on timely treatment initiation and adherence to follow-up care in (n=100). The pilot intervention in this study will determine effective recruitment and study participant retention strategies, intervention feasibility and acceptability, and best timing to initiate the intervention, length of intervention, and required sample size.

The primary outcome of this pilot intervention is to assess feasibility of a full-scale intervention study by determining: 1) how many patients are screened and enrolled per month, 2) how many enrolled patients participate in each intervention activity/assessment, 3) how well study participants complete each assessment (adherence to the intervention), and 4) what proportion of enrolled patients complete the intervention. Through this pilot study, the investigators will assess if the proposed intervention is acceptable to Hispanic kidney and liver cancer patients.

Additionally, the investigators will evaluate the effect of social support intervention on timely treatment initiation after diagnosis. Timely treatment after diagnosis will be based on time in days between cancer diagnosis with CT or MRI to initiation of definitive treatment (e.g., surgery, liver transplant, or ablation). Many kidney and liver cancer patients initiate treatment within 3 months after the diagnosis and continue to have follow-up care. Kidney cancer patients undergo an imaging assessment for other reasons and have incidental findings of a kidney mass. Adherence to follow-up care will be assessed based on whether patients schedule and show up for follow-up imaging assessment or scheduled appointments with hepatologists or urologists and how long the delay in the follow-up care is.

Intervention materials will be adapted from an existing, manualized symptom management intervention shown to be effective in reducing symptom burden in cancer survivors. Drs. Batai and Valencia will supervise the revision, translation, cultural adaptation, and illustration of the intervention to be linguistically and culturally appropriate for Spanish-speaking cancer survivors and caregivers. Intervention education materials will serve as an evidence-based guide for easy reference, including frequently asked questions, information on when to contact the health care provider (when patients have symptoms), strategies for communication with health care providers, family members and friends, and information on lifestyle modification (i.e. diet and physical activity) for cancer patients.

The results of this pilot intervention will be used to develop a larger, adequately-powered randomized controlled trial to robustly evaluate the effects of integrating existing social networks into care to reduce the negative effect of social deprivation and improve timeliness of treatment initiation and adherence to recommended treatment.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Screening and enrollment figures
timeFrame: Screening and enrollment
measure: Study retention
timeFrame: 6-months post enrollment (end of the intervention)
measure: Completeness of data collection
timeFrame: 9-months post enrollment
measure: Participant adherence to the intervention
timeFrame: 6-months post enrollment (end of intervention)
measure: Acceptability of the intervention
timeFrame: 9-months post enrollment
Secondary outcomes:
measure: Mean and median time to treatment initiation in the control vs. intervention group
timeFrame: 6-months post enrollment (end of intervention) and 12-months
measure: Proportion of patients who attend a follow-up imaging assessment after their surgery with hepatologists or urologists in control vs. intervention group
timeFrame: 6-months post enrollment (end of intervention), 12-months, and 18-months
measure: Proportion of patients who attend a scheduled appointment after their surgery with hepatologists or urologists in control vs. intervention group
timeFrame: 6-months post enrollment (end of intervention), 12-months, and 18-months
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Ken Batai, PhD
role: PRINCIPAL_INVESTIGATOR
References: