Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants randomized to the mPATH arm will complete a self-survey and a brief video decision aid, and then invites them to estimate their personal risks and benefits of screening by completing 8 survey items needed to calculate their predicted risk of developing lung cancer based on the validated Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Model 2012.

Participants randomized to the control arm will see an animated video about exercise for lung health based on recommendations from the European Lung Foundation. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.

A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.

mPATH-Lung

Web-based video about guideline recommended exercise for lung health

Lung health video

David P Miller, MD, MS

mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.

This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.

Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.

Secondary Objectives:

* Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.
* Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings

Digital Outreach Intervention for Lung Cancer Screening

A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)

We will share de-identified individual participant data that underlie our published or presented results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.

Completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review

Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only

The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed

The proportion of patients in each arm who have completed a LCS clinic visit

The proportion of patients in each arm for whom a LCS scan was ordered

The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.

The results of a completed lung cancer screening CT, reported using the Lung-RADS classification

A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.

The proportion of patients in each arm who undergo an invasive procedure following a LCS scan

The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan

Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization

Proportion of patients who had lung cancers detected related to screening or incidentally.

The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.

The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.

The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.

University of North Carolina, Chapel Hill

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Symptoms and General Pathology

Pain

Questionnaire completed using pen and paper

Questionnaire is transferred wireless to the physician's PC

CCADSS

Questionnaire completed and transferred to the physician using standard methods

pen-paper

Stein Kaasa, MD prof

This study aims to investigate computer based symptom assessment in an outpatient cancer population, and the use of a computer based decision support system to facilitate the diagnosis and treatment of cancer related pain.

Primary hypothesis is, that this approach improves pain control and pain management in an unselected group of cancer patients in an outpatient setting.

* Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale
* Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale
* An alteration in the prescribing dose of opioids in equipotent opioid dosage

Secondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.

The traditional way of symptom assessment is by the paper-and-pen method, which suffers from several limitations. The assessment items are not individually adjusted to each patient and his/her subjective symptoms, the collected data is rarely used in clinical practice, and decision-support for the physician is not possible.

Although the body of evidence is accumulating regarding the benefits of computerised symptom assessment in cancer patients, there is still insufficient knowledge of the impact of computerised assessment tools on the management of cancer pain and other cancer related symptoms.

The COMBAT study aims to investigate if a computer based assessment of cancer related symptoms, and a computerized decision support can improve treatment of pain and other symptoms in cancer patients.

This is an open, comparative study with a sequential design with two consecutive study periods, the non-intervention period and the intervention period.

The computer-based clinical decision support system will utilize the following data to generate one or several treatment options:

1. Data from self assessment of cancer related symptoms
2. Data from relevant variables reported by the physician
3. Revisited guidelines on treatment of cancer pain

Computer Based Assessment and Treatment

- The Brief Pain Inventory (BPI, a self-reported pain assessment tool aiming to quantify two aspects of cancer pain: Pain intensity and the functional disability as a result of cancer pain.

- The Alberta Breakthrough Pain Assessment Tool for cancer patients (ABPAT), a questionnaire developed in order to measure several dimensions of cancer-related breakthrough pain. It contains 15 questions, and was translated into Norwegian by our research group according to EORTC's rules for translation.

- The Edmonton Symptom Assessment System (ESAS), a validated standardized questionnaire consisting of 10 items, which evaluate physical and psychological symptoms as well as general wellbeing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Digital Outreach Intervention for Lung Cancer Screening	NCT04083859	Lung Cancer	mPATH-Lung Lung health vid...	50 Years - 77 Years	Wake Forest University Health Sciences
Computer Based Assessment and Treatment	NCT01795157	Neoplasms Pain	CCADSS pen-paper	18 Years -	Norwegian University of Science and Technology
Computer Based Assessment and Treatment	NCT01795157	Neoplasms Pain	CCADSS pen-paper	18 Years -	Norwegian University of Science and Technology

Spots Global Cancer Trial Database for decision making, computer assisted