NCT07716527

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2026Oct 2026

Study Start

First participant enrolled

June 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 30, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Lung cancer screeningDigital health toolWeb-based prototypePrototypeDecision support

Outcome Measures

Primary Outcomes (1)

  • Self- reported receipt of Lung Cancer Screening

    Self-reported receipt of LCS within 3 months of exposure to the digital health tool

    3 months

Secondary Outcomes (10)

  • Lung Cancer Screening Intention

    Immediately post-intervention (within 24 hours)

  • Stage of Decision Making

    Immediately post-intervention (within 24 hours)

  • Ottowa Acceptability Measure

    Immediately post-intervention (within 24 hours)

  • System Usability Scale (SUS)

    Immediately post-intervention (within 24 hours)

  • Knowledge of LCS

    Immediately post-intervention (within 24 hours)

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Digital health tool prototype

Control

ACTIVE COMPARATOR
Behavioral: Control Arm - standard of care

Interventions

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.

Intervention

The control arm will read a 2-page educational material about lung cancer screening publicly available from American Cancer Society.

Control

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Medicine

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 21, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations