Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization

December 28, 2020 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • English-speaking
  • Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
  • Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at MSKCC as per the patients clinical team
  • Referred to MSK's Tobacco Cessation Program
  • Patient-reported cigarette use within the past 30 days
  • Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
  • Can be reached by telephone

Exclusion Criteria:

  • Distant metastatic disease at the time of enrollment
  • Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
  • Any patients who are unable to comply with the study procedures as determined by the study investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care

usual care, which consists of four (face-to-face or telephone) counseling sessions with a trained nurse who has expertise in helping cancer patients quit smoking. This is the same as the treatment an MSK patient who enrolls in the MSK smoking cessation program would receive.

To collect further data to improve the game intervention, the investigators will conduct semi-structured telephone interviews with patients who were randomized to the treatment arm but did not play the game during the one month intervention period. The purpose of the interviews is to elicit qualitative feedback on any barriers that may have prevented participants from playing. At the completion of the intervention period, patients will be asked if they would like to participate in a telephone interview. Telephone interviews will take about twenty minutes and will be held at a time that is convenient for the patient.

In order to maximize survey the response rate, patients will be mailed a reminder letter approximately two weeks before the 1 month follow up surveys are due. If the survey is not returned, patients will be sent additional reminders on the survey due date as well as two weeks past the due date.
The investigators will inform patients prior to obtaining their self-reports that a saliva test or expired CO sample for those using NRT or electronic cigarettes will be performed to examine recent tobacco exposure.
Experimental: Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).
Smokers randomly assigned to SC+SCCS/Quit IT will receive all the components of Standard Care. The patient will be oriented and trained face-to-face (during their hospitalization) on use of the game by study staff using an iPad. The orientation and training session will comprise: 1) Overview of the game and its objectives; 2) discussion of the rules of the game; 3) watching a 10 minute tutorial given by the game narrator (avatar); 4) answering all patient questions; and 5) evaluation of the patient's comprehension of game play via a 17 question survey. Once patients have access to QuitIT, they will also receive a set of Coping Cards
In order to maximize survey the response rate, patients will be mailed a reminder letter approximately two weeks before the 1 month follow up surveys are due. If the survey is not returned, patients will be sent additional reminders on the survey due date as well as two weeks past the due date.
The investigators will inform patients prior to obtaining their self-reports that a saliva test or expired CO sample for those using NRT or electronic cigarettes will be performed to examine recent tobacco exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quitting smoking self-efficacy
Time Frame: 1 year
as measured by the Confidence Questionnaire to assess changes in confidence in being able to resist urges to smoke across everyday situations.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of the game
Time Frame: 1 year
on smoking abstinence and relapse prevention. We will examine time to smoking relapse following hospitalization, measured as part of the follow-up Smoking Status 1 month following enrollment. We will also biochemically verify 7-day point prevalence smoking abstinence at the 1 month follow-up assessment.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2014

Primary Completion (Actual)

December 24, 2020

Study Completion (Actual)

December 24, 2020

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 14-062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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