search
Back to results

Assessing Social Determinants of Health to Increase Cancer Screening

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social determinants of health screening assessment and referral process
Current practice - Community-based lunch cancer screening (LungTalk)
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring screening, social determinants of health, lung cancer screening

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 50 years to 80 years Currently smoke or quit smoking within the past 15 years 20 pack-year smoking history Has never had lung cancer screening Able to provide informed consent Able to speak and understand English Exclusion Criteria: Diagnosed with lung cancer Has a history of having a lung cancer screening scan Unable to speak and understand English

Sites / Locations

  • Hackensack Meridian Health - Center for Discovery and InnovationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social determinants of health screening

Community-based lung cancer screening

Arm Description

Participants will receive a social determinants of health screening assessment and referral process in addition to the community-based lung cancer screening educational tool.

Participants will receive a community-based lung cancer screening educational tool.

Outcomes

Primary Outcome Measures

Lung cancer screening uptake
Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan)

Secondary Outcome Measures

Health Literacy
Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level)
Health Literacy
Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level)
Medical Mistrust
Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)
Medical Mistrust
Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)
Perceived Smoking-Related Stigma
Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma)
Perceived Smoking-Related Stigma
Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma)
Lung Cancer Fatalism
Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)
Lung Cancer Fatalism
Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)
Knowledge of Lung Cancer and Lung Screening
Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).
Knowledge of Lung Cancer and Lung Screening
Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).
Perceived Barriers to Lung Cancer Screening Scale
Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening).
Perceived Barriers to Lung Cancer Screening Scale
Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening).
Stage of Adoption for Decision-Making About Lung Screening
Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".
Stage of Adoption for Decision-Making About Lung Screening
Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".

Full Information

First Posted
September 19, 2023
Last Updated
October 3, 2023
Sponsor
Hackensack Meridian Health
Collaborators
Becton, Dickinson and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT06052449
Brief Title
Assessing Social Determinants of Health to Increase Cancer Screening
Official Title
Assessing Social Determinants of Health to Increase Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
Becton, Dickinson and Company

4. Oversight

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

5. Study Description

Brief Summary
A multilevel lung screening intervention that pairs Social Determinants of Health (SDoH) screening and referral with a tailored health communication and decision support tool for lung screening has the potential to significantly impact lung screening uptake among at-risk individuals in the community, particularly among those who face barriers related to SDoH. In addition, findings will advance the understanding of effective strategies for improving lung screening and prevention efforts in non-traditional settings, with the ultimate goal of reducing the burden of lung cancer. As ways to support the realization of the public health benefit of lung cancer screening are considered, multiple strategies and venues to reach, and intervene, with screening-eligible is key. The goal of this study is to compare the effectiveness of a community-based lung screening educational tool paired with a social determinants of health (SDoH) screening assessment and referral process compared to a community-based lung cancer screening (LCS) educational tool alone as part of community outreach activities to improve (a) LCS rates (primary outcome); (b) intention to screen; and (c) individual-level potential drivers of LCS (health literacy, mistrust, stigma, fatalism, knowledge, health beliefs). It is hypothesized that providing SDoH screening and referral will result in higher levels of LCS, forward movement of intention to screen, and improved individual-level drivers of LCS.
Detailed Description
The study will be a pilot randomized controlled trial (RCT) to compare primary (LCS uptake) and secondary outcomes (intent to screen, literacy, mistrust, stigma, fatalism, health beliefs) among LCS-eligible men and women in New Jersey community-based settings who receive a community-based LCS educational tool paired with a social determinants of health (SDoH) screening assessment and referral process (n=50) compared to a community-based LCS educational tool alone (n=50) as part of community outreach activities. All individuals who attend a community event are normally assessed for cancer risks and appropriate cancer screening education is provided. For those who are eligible for LCS, they will also be invited to participate in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
screening, social determinants of health, lung cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social determinants of health screening
Arm Type
Experimental
Arm Description
Participants will receive a social determinants of health screening assessment and referral process in addition to the community-based lung cancer screening educational tool.
Arm Title
Community-based lung cancer screening
Arm Type
Active Comparator
Arm Description
Participants will receive a community-based lung cancer screening educational tool.
Intervention Type
Behavioral
Intervention Name(s)
Social determinants of health screening assessment and referral process
Intervention Description
Unite Us is an electronic SDoH screening and referral tool assessing: (1) financial resource strain; (2) housing stability; (3) transportation needs; and (4) food insecurity. Upon completion, the Unite Us platform identifies a list of geographically-tailored resources to connect the individual in need. A staff member will administer the SDoH screening and referral tool, review the results with the participant, and use the geographically-tailored resources to make SDoH-related referrals.
Intervention Type
Behavioral
Intervention Name(s)
Current practice - Community-based lunch cancer screening (LungTalk)
Intervention Description
The current practice during community events is to offer LungTalk. LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled LCS knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% Confidence Interval (CI), 1.03, 3.85, p = 0.03.
Primary Outcome Measure Information:
Title
Lung cancer screening uptake
Description
Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan)
Time Frame
3 months post intervention
Secondary Outcome Measure Information:
Title
Health Literacy
Description
Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level)
Time Frame
Baseline
Title
Health Literacy
Description
Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level)
Time Frame
3 months post intervention
Title
Medical Mistrust
Description
Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)
Time Frame
Baseline
Title
Medical Mistrust
Description
Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)
Time Frame
3 months post intervention
Title
Perceived Smoking-Related Stigma
Description
Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma)
Time Frame
Baseline
Title
Perceived Smoking-Related Stigma
Description
Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma)
Time Frame
3 months post intervention
Title
Lung Cancer Fatalism
Description
Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)
Time Frame
Baseline
Title
Lung Cancer Fatalism
Description
Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)
Time Frame
3 months post intervention
Title
Knowledge of Lung Cancer and Lung Screening
Description
Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).
Time Frame
Baseline
Title
Knowledge of Lung Cancer and Lung Screening
Description
Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).
Time Frame
3 months post intervention
Title
Perceived Barriers to Lung Cancer Screening Scale
Description
Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening).
Time Frame
Baseline
Title
Perceived Barriers to Lung Cancer Screening Scale
Description
Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening).
Time Frame
3 months post intervention
Title
Stage of Adoption for Decision-Making About Lung Screening
Description
Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".
Time Frame
Baseline
Title
Stage of Adoption for Decision-Making About Lung Screening
Description
Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".
Time Frame
3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 50 years to 80 years Currently smoke or quit smoking within the past 15 years 20 pack-year smoking history Has never had lung cancer screening Able to provide informed consent Able to speak and understand English Exclusion Criteria: Diagnosed with lung cancer Has a history of having a lung cancer screening scan Unable to speak and understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Valenzona
Phone
2018803400
Email
francis.valenzona@hmh-cdi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Carter-Bawa, PhD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health - Center for Discovery and Innovation
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
07110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Valenzona
Phone
201-880-3400
Email
francis.valenzona@hmh-cdi.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Cancer Facts & Figures 2023. American Cancer Society, Inc.; 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts-figures.html
Results Reference
background
PubMed Identifier
36205665
Citation
Pettit N, Ceppa D, Monahan P. Low Rates of Lung and Colorectal Cancer Screening Uptake Among a Safety-net Emergency Department Population. West J Emerg Med. 2022 Aug 11;23(5):739-745. doi: 10.5811/westjem.2022.5.55351.
Results Reference
background
PubMed Identifier
26701339
Citation
Carter-Harris L, Ceppa DP, Hanna N, Rawl SM. Lung cancer screening: what do long-term smokers know and believe? Health Expect. 2017 Feb;20(1):59-68. doi: 10.1111/hex.12433. Epub 2015 Dec 23.
Results Reference
background
PubMed Identifier
28122849
Citation
Carter-Harris L, Brandzel S, Wernli KJ, Roth JA, Buist DSM. A qualitative study exploring why individuals opt out of lung cancer screening. Fam Pract. 2017 Apr 1;34(2):239-244. doi: 10.1093/fampra/cmw146.
Results Reference
background
PubMed Identifier
31550991
Citation
Carter-Harris L, Slaven JE 2nd, Monahan PO, Draucker CB, Vode E, Rawl SM. Understanding lung cancer screening behaviour using path analysis. J Med Screen. 2020 Jun;27(2):105-112. doi: 10.1177/0969141319876961. Epub 2019 Sep 24. Erratum In: J Med Screen. 2019 Nov 5;:969141319888037.
Results Reference
background
PubMed Identifier
32556187
Citation
Mohan G, Chattopadhyay S. Cost-effectiveness of Leveraging Social Determinants of Health to Improve Breast, Cervical, and Colorectal Cancer Screening: A Systematic Review. JAMA Oncol. 2020 Sep 1;6(9):1434-1444. doi: 10.1001/jamaoncol.2020.1460.
Results Reference
background
Citation
Weinstein D. The Precaution Adoption Process Model. In: Health Behavior and Health Education: Theory, Researchm and Practice. 4th Ed. Jossey-Bass; 2008:123-147.
Results Reference
background
PubMed Identifier
15343421
Citation
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
Results Reference
background
PubMed Identifier
14715214
Citation
Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004 Feb;38(2):209-18. doi: 10.1016/j.ypmed.2003.09.041.
Results Reference
background
PubMed Identifier
21186151
Citation
Cataldo JK, Slaughter R, Jahan TM, Pongquan VL, Hwang WJ. Measuring stigma in people with lung cancer: psychometric testing of the cataldo lung cancer stigma scale. Oncol Nurs Forum. 2011 Jan;38(1):E46-54. doi: 10.1188/11.ONF.E46-E54.
Results Reference
background
PubMed Identifier
11217186
Citation
Mayo RM, Ureda JR, Parker VG. Importance of fatalism in understanding mammography screening in rural elderly women. J Women Aging. 2001;13(1):57-72. doi: 10.1300/J074v13n01_05.
Results Reference
background
PubMed Identifier
27244666
Citation
Carter-Harris L, Slaven JE 2nd, Monohan P, Rawl SM. Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017 May/Jun;40(3):237-244. doi: 10.1097/NCC.0000000000000386.
Results Reference
background
PubMed Identifier
31078660
Citation
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Results Reference
background

Learn more about this trial

Assessing Social Determinants of Health to Increase Cancer Screening

We'll reach out to this number within 24 hrs