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Rural Lung and Head and Neck Cancer Intervention

Primary Purpose

Lung Cancer, Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARES Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. Male and female adults over 18 years old
  4. English or Spanish speaking
  5. Receives cancer treatment at University of Colorado Hospital (UCH) , SCL-St. Mary's Medical Center, or Rocky Mountain Cancer Centers (RMCC) in Pueblo, CO.
  6. Resides in any of the rural counties served by one of the collaborating sites with Rural-Urban Continuum Codes (RUCC) codes 4-9.
  7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology [ICD-O] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants
  8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging [AJCC] Tumor Node Metastasis [TNM] stages: I-IV)
  9. Will receive the following types of LC and/or HNC treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy)
  10. Diagnosed with HNC using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants
  11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV
  12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants
  13. Inclusion Criteria Confirmed via Baseline Survey
  14. Rural and medically underserved, defined as meeting the following criteria:
  15. Rural: Resides in a rural county with a RUCC code 4-9 AND,
  16. Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR
  17. Uninsured: No health insurance (public or private insurance) AND/OR
  18. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses

Exclusion Criteria:

  • Exclusion Criteria Assessed During Screening:

    1. Children under 18 years old
    2. Individuals who do not speak English or Spanish
    3. Individuals not receiving cancer treatment at one of the collaborating sites
    4. Diagnosed with primary cancer other than LC and/or HNC, or other type of LC and/or HNC not listed in the inclusion criteria
    5. Diagnosed with a type of LC or HNC listed under inclusion criteria but will not be treated at one of the collaborating hospital sites
    6. Has already initiated curative treatment for the current episode of cancer
  • Exclusion Criteria Assessed via Baseline Survey:

    1. Individuals from vulnerable populations (e.g., inmates or on probation, homeless*, and pregnant*)
    2. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study
    3. Unable to hear (not including individuals who can hear with an auditory aid)*
    4. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) *Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion

Sites / Locations

  • University of Colorado HospitalRecruiting
  • Memorial Hospital CentralRecruiting
  • Memorial Hospital NorthRecruiting
  • Poudre Valley HospitalRecruiting
  • SCL- St. Mary's Medical Center
  • Greeley CampusRecruiting
  • Highlands Ranch HospitalRecruiting
  • Medical Center of the RockiesRecruiting
  • San Juan Cancer CenterRecruiting
  • Rocky Mountain Cancer CenterRecruiting
  • Yampa Valley Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CARES Intervention

Usual Care

Arm Description

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.

All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.

Outcomes

Primary Outcome Measures

Time to care
Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion

Secondary Outcome Measures

Quality of Care
Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience
Patient Reported Outcomes
Use Patient Reported Outcomes (PRO) questionnaire o determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use

Full Information

First Posted
June 1, 2021
Last Updated
June 23, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04916990
Brief Title
Rural Lung and Head and Neck Cancer Intervention
Official Title
Improving the Timeliness and Quality of Care for Rural Lung and Head-and-Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Lung Cancer and Head and Neck Cancer 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CARES Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.
Intervention Type
Behavioral
Intervention Name(s)
CARES Intervention
Intervention Description
Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes
Primary Outcome Measure Information:
Title
Time to care
Description
Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion
Time Frame
From study start to study end (6 months)
Secondary Outcome Measure Information:
Title
Quality of Care
Description
Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience
Time Frame
From study start to study end (6 months)
Title
Patient Reported Outcomes
Description
Use Patient Reported Outcomes (PRO) questionnaire o determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
Time Frame
From study start to study end (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision to sign and date the consent form. Stated willingness to comply with all study procedures and be available for the duration of the study. Male and female adults over 18 years old English or Spanish speaking Receives cancer treatment at University of Colorado Hospital (UCH) , SCL-St. Mary's Medical Center, or Rocky Mountain Cancer Centers (RMCC) in Pueblo, CO. Resides in any of the rural counties served by one of the collaborating sites with Rural-Urban Continuum Codes (RUCC) codes 4-9. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology [ICD-O] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging [AJCC] Tumor Node Metastasis [TNM] stages: I-IV) Will receive the following types of LC and/or HNC treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy) Diagnosed with HNC using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants Inclusion Criteria Confirmed via Baseline Survey Rural and medically underserved, defined as meeting the following criteria: Rural: Resides in a rural county with a RUCC code 4-9 AND, Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR Uninsured: No health insurance (public or private insurance) AND/OR Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses Exclusion Criteria: Exclusion Criteria Assessed During Screening: Children under 18 years old Individuals who do not speak English or Spanish Individuals not receiving cancer treatment at one of the collaborating sites Diagnosed with primary cancer other than LC and/or HNC, or other type of LC and/or HNC not listed in the inclusion criteria Diagnosed with a type of LC or HNC listed under inclusion criteria but will not be treated at one of the collaborating hospital sites Has already initiated curative treatment for the current episode of cancer Exclusion Criteria Assessed via Baseline Survey: Individuals from vulnerable populations (e.g., inmates or on probation, homeless*, and pregnant*) Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study Unable to hear (not including individuals who can hear with an auditory aid)* Likely inability to track the individual over time (e.g. no permanent address at the time of consent) *Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Jones
Phone
3037240884
Email
Christopher.2.jones@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelinn Borrayo, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Phone
303-724-3912
Email
Christopher.2.jones@cuanschutz.edu
Facility Name
Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
Facility Name
Memorial Hospital North
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Steven Schuster, MD
Facility Name
SCL- St. Mary's Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marty Jacobsen
Phone
970-298-1822
Email
Marty.Jacobson@sclhs.net
Facility Name
Greeley Campus
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80634
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Steven Schuster, MD
Facility Name
Highlands Ranch Hospital
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanshcutz.edu
First Name & Middle Initial & Last Name & Degree
Ryan Lanning, MD
First Name & Middle Initial & Last Name & Degree
Poojitha Valasareddy, MD
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Steven Schuster, MD
Facility Name
San Juan Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
Facility Name
Rocky Mountain Cancer Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
Facility Name
Yampa Valley Medical Center
City
Steamboat Springs
State/Province
Colorado
ZIP/Postal Code
80487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Jones
Email
christopher.2.jones@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Steven Schuster, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Rural Lung and Head and Neck Cancer Intervention

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