Improving Care for Rural Patients With Solid Tumors

Not Applicable

Recruiting

• Conditions: Thyroid Cancer; Breast Cancer; Bladder Cancer; Head and Neck Cancer; Cervical Cancer; Colon Cancer; Rectum Cancer; Lung Cancer
• Interventions: Behavioral: CARES Intervention

• Registration Number: NCT04916990
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.

Detailed Description

This is a randomized study. 320 participants will be enrolled to the CARES intervention or usual care arms. All participants will complete surveys to assess Quality of Care and Patient Reported outcomes at baseline, 3 months and 6 months. The CARES intervention will include a maximum of 10 navigation and 10 counseling sessions delivered over approximately a 6- month period delivered by oncology nurse navigators and master's level counselors. Sessions will be scheduled to correspond with key transition points during treatment and may be held in person, virtually, or by phone. Patients enrolled to the usual care arm will receive a standardized list of resources. Participation will last 6 months.

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-08
• Study Start: 2022-09-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CARES Intervention	CARES Intervention	All participants will complete surveys to assess Quality of Care and Patient Reported outcomes at baseline, 3 months and 6 months. The CARES intervention will include a maximum of 10 navigation and 10 counseling sessions delivered over approximately a 6- month period delivered by oncology nurse navigators and master's level counselors. Sessions will be scheduled to correspond with key transition points during treatment and may be held in person, virtually, or by phone.

Primary Outcome Measures

Name	Time	Method
Time to care	From study start to study end (6 months)	Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes	From study start to study end (6 months)	Use Patient Reported Outcomes (PRO) questionnaire o determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
Quality of Care	From study start to study end (6 months)	Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience

Trial Locations

Locations (12)

UCHealth - Parkview medical Center; 🇺🇸 Pueblo, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Memorial Hospital Central; 🇺🇸 Colorado Springs, Colorado, United States

Memorial Hospital North; 🇺🇸 Colorado Springs, Colorado, United States

Poudre Valley Hospital; 🇺🇸 Fort Collins, Colorado, United States

SCL- St. Mary's Medical Center; 🇺🇸 Grand Junction, Colorado, United States

Greeley Campus; 🇺🇸 Greeley, Colorado, United States

Highlands Ranch Hospital; 🇺🇸 Highlands Ranch, Colorado, United States

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States

San Juan Cancer Center; 🇺🇸 Montrose, Colorado, United States

Rocky Mountain Cancer Center; 🇺🇸 Pueblo, Colorado, United States

Yampa Valley Medical Center; 🇺🇸 Steamboat Springs, Colorado, United States