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Pilot Testing a Web-based Prototype of a Lung Cancer Screening Digital Health Tool

2026년 7월 15일 업데이트: Naomi Tan, PhD, Rutgers, The State University of New Jersey
The purpose of this study is to evaluate the acceptability, usability, and preliminary efficacy of a web-based prototype of a digital health tool for lung cancer screening (LCS). The digital health tool is designed to support high quality decision-making for individuals potentially eligible for lung cancer screening. Researchers will compare the intervention arm (who will use the digital health tool prototype) with the control arm (who will read a 2-page publicly available information sheet about lung cancer screening from American Cancer Society).

연구 개요

상세 설명

Lung cancer is the leading cause of cancer death in the US. In 2011, the landmark National Lung Screening Trial demonstrated that LCS using low-dose computed tomography (LDCT) can reduce lung cancer mortality by 20%, compared to chest X-rays, after annual screenings. Hence, the United States Preventive Services Task Force (USPSTF) recommends LCS for individuals age 50-80, who currently smoke or quit smoking within the past 15 years, and who have at least a 20 pack-year smoking history. The USPSTF gave LCS a Grade B recommendation, indicating that there is high certainty that the benefits of LCS outweigh the risks for this population. Despite the well-documented benefits of LCS and USPSTF's Grade B recommendation, LCS uptake remains very low at only 18%. In contrast, breast and colon cancer screening rates exceed 70%, even though their combined annual deaths are ¾ that of lung cancer. As LCS has both potential benefits and harms (e.g., false positives, small amounts of radiation exposure, potential invasive diagnostic testing), USPSTF also recommends that all patients undergo shared decision-making (SDM) prior to initial screening. Furthermore, the Centers for Medicare & Medicaid Services (CMS) mandates an SDM conversation using a decision aid prior to initial screening. Yet, SDM is not routinely performed and patients are rarely informed about potential harms in routine practice. Hence, interventions aiming to improve LCS uptake and decision quality among high-risk populations are urgently needed to realize the mortality benefit of LCS.

To address these gaps, the investigators will develop a digital health tool, which is an interactive website that delivers high-quality, standardized SDM and psychoeducation about LCS to patients. This study's aims are to: 1) evaluate acceptability of the digital health tool prototype among people with a smoking history; 2) assess changes in cognitive outcomes before and after exposure to the digital health tool and across comparison groups; and 3) assess the digital health tool's impact on LCS intentions.

The digital health tool includes a home page and 7 modules: 1) a video decision aid about LCS; 2) video of the LDCT procedure; 3) lung cancer risk calculator and individualized lung cancer risk scores for patients; 4) patient testimonials; 5) frequently asked questions (e.g., costs associated with LDCT); 6) patient's decision; and 7) resources for smoking cessation.

For this pilot study, the investigators will be utilizing a quantitative approach using surveys. This study will use a randomized pre-post design to assess the impact of exposure to the digital health tool prototype. Participants (N=500) will be randomized to view either the digital health tool prototype or standard education materials about LCS in a 1:1 ratio. Participants will be contacted 3 months after the initial survey to complete a brief follow-up survey assessing LCS behavior.

Participants will be recruited through Qualtrics Research Panels. Potential participants will complete a screening form to confirm their eligibility. The inclusion criteria are: 1) age 50-80; and 2) currently smoke or quit smoking within the past 15 years. If they are eligible, potential participants will be directed to an informed consent form where they will be asked to indicate their agreement to participate in this study. Participants who agree to participate will then complete a pre-survey, use either the digital health tool prototype or standard education materials, and then complete a post-survey. 3 months after the initial survey, participants will be contacted again to complete a follow-up survey.

연구 유형

중재적

등록 (추정된)

500

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New Jersey
      • New Brunswick, New Jersey, 미국, 08901
        • Rutgers Cancer Institute of New Jersey

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age 50-80 years
  • Currently smoke or have quit smoking within the past 15 years
  • English-speaking

Exclusion Criteria:

  • Younger than 50 years or older than 80 years
  • Never smoked or quit smoking more than 50 years ago
  • Non-English-speaking

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 간섭
Intervention participants will view a web-based interactive prototype of the digital health tool. The digital health tool contains information about lung cancer screening, the screening procedures, a personalized lung cancer risk calculator, patient stories, frequently asked questions, and smoking cessation resources.
활성 비교기: 제어
The control arm will read a 2-page educational material about lung cancer screening publicly available from American Cancer Society.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Self- reported receipt of Lung Cancer Screening
기간: 3 months
Self-reported receipt of LCS within 3 months of exposure to the digital health tool
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Lung Cancer Screening Intention
기간: Immediately post-intervention (within 24 hours)
Intention to undergo LCS in the next 3 months, measured during the post-test survey administered immediately after viewing the digital health tool. Patient will respond on a 4-point agreement scale (strongly agree/agree/disagree/strongly disagree).
Immediately post-intervention (within 24 hours)
Stage of Decision Making
기간: Immediately post-intervention (within 24 hours)
Stage of decision making will be assessed using the validated single-item Stage of Decision Making Scale. The measure assesses participants' readiness to make a decision regarding lung cancer screening by asking them to select one of six statements describing their current stage of decision making, ranging from not yet thinking about the decision to having made a decision and being unlikely to change their mind. Responses are coded on a 6-point ordinal scale, with higher scores indicating greater readiness or progression toward making a decision.
Immediately post-intervention (within 24 hours)
Ottowa Acceptability Measure
기간: Immediately post-intervention (within 24 hours)
Acceptability will be assessed using the 10-item validated Ottawa Acceptability of Decision Aid Measure. The Ottawa Acceptability Measure has 8 items evaluating each section of the digital health tool (4-point Likert scale ranging from Poor to Excellent), length of presentation (too short/too long/just right), amount of information (too much/too little/just right), balance (slanted towards LCS/not slanted towards LCS/balanced), usefulness of the website (yes/no), risk calculation understanding (easy/difficult), and enough information (yes/no). The measure also includes two open-ended questions regarding what participants liked about the website and suggested improvements.
Immediately post-intervention (within 24 hours)
System Usability Scale (SUS)
기간: Immediately post-intervention (within 24 hours)
Website usability will be assessed using the 10-item validated System Usability Scale (SUS). The SUS evaluates participants' overall perceptions of the usability of the digital health tool, including ease of use, complexity, consistency, confidence while using the system, and willingness to use the system frequently. Each item is rated on a 5-point Likert scale ranging from Strongly disagree to Strongly agree. After reverse scoring negatively worded items, responses are summed and converted to a 0-100 scale, with higher scores indicating better perceived usability.
Immediately post-intervention (within 24 hours)
Knowledge of LCS
기간: Immediately post-intervention (within 24 hours)
Knowledge of lung cancer screening will be assessed using the 20-item Lung Cancer Screening Knowledge Measure (LCS-15). The LCS-15 evaluates participants' knowledge of lung cancer screening, including eligibility criteria, screening frequency, potential benefits and harms of low-dose computed tomography (LDCT), false-positive results, overdiagnosis, incidental findings, radiation exposure, follow-up testing, and the importance of smoking cessation. Each item is answered using correct, incorrect, or "I don't know" response options. Correct responses are scored as 1, while incorrect and "I don't know" responses are scored as 0. Item scores are summed and converted to a 0-100% score, with higher scores indicating greater knowledge of lung cancer screening.
Immediately post-intervention (within 24 hours)
Perceived risk
기간: Immediately post-intervention (within 24 hours)
Perceived risk of lung cancer will be assessed using the 3-item Perceived Risk subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale measures participants' perceived susceptibility to developing lung cancer by assessing their perceived risk, likelihood of developing lung cancer in the next few years, and overall likelihood of developing lung cancer. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 3 to 12, with higher scores indicating greater perceived risk of developing lung cancer.
Immediately post-intervention (within 24 hours)
Perceived benefits
기간: Immediately post-intervention (within 24 hours)
Perceived benefits of lung cancer screening will be assessed using the 6-item Perceived Benefits subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale evaluates participants' beliefs about the benefits of undergoing lung cancer screening with low-dose computed tomography (LDCT), including beliefs that screening can detect lung cancer early, improve treatment outcomes, and reduce the risk of dying from lung cancer. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 6 to 24, with higher scores indicating stronger perceived benefits of lung cancer screening.
Immediately post-intervention (within 24 hours)
Perceived barriers
기간: Immediately post-intervention (within 24 hours)
Perceived barriers to lung cancer screening will be assessed using the 17-item Perceived Barriers subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale assesses participants' perceived emotional, practical, and logistical barriers to completing lung cancer screening, including concerns about cost, fear, time, transportation, inconvenience, and access. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 17 to 68, with higher scores indicating greater perceived barriers to lung cancer screening.
Immediately post-intervention (within 24 hours)
Decisional Conflict (SURE)
기간: Immediately post-intervention (within 24 hours)
Decisional conflict will be assessed using the 4-item validated SURE Test. The SURE Test evaluates whether participants feel certain about the best choice, understand the benefits and risks of available options, are clear about which benefits and risks matter most to them, and have sufficient support and advice to make a decision. Items are answered using Yes/No response options. Responses are summed to produce a total score ranging from 0 to 4, with higher scores indicating less decisional conflict and greater confidence in decision making.
Immediately post-intervention (within 24 hours)
Preparation for Decision Making
기간: Immediately post-intervention (within 24 hours)
Preparation for decision making will be assessed using the 10-item validated Preparation for Decision Making Scale (PrepDM). The PrepDM measures the extent to which the digital health tool prepares participants to communicate with their healthcare provider and make an informed decision about lung cancer screening. Items assess whether the tool helped participants recognize that a decision needs to be made, understand the benefits and harms of screening, clarify what matters most to them, organize their thoughts, identify questions for their healthcare provider, and prepare to discuss their preferences and make a decision. Each item is rated on a 5-point Likert scale ranging from Not at all to A great deal. Item scores are averaged and transformed to a 0-100 scale, with higher scores indicating greater perceived preparation for decision making.
Immediately post-intervention (within 24 hours)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 1일

기본 완료 (추정된)

2026년 10월 15일

연구 완료 (추정된)

2026년 10월 15일

연구 등록 날짜

최초 제출

2026년 6월 30일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Pro2026000388

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

As this study represents a prototype phase of tool development, the underlying data are not being made publicly available at this time. The data will be used to inform ongoing refinement and validation of the digital health tool prior to broader dissemination.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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