NCT02099097

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 24, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

6.8 years

First QC Date

March 25, 2014

Last Update Submit

December 28, 2020

Conditions

Keywords

3D Coping Skills GameQuit smoking14-062

Outcome Measures

Primary Outcomes (1)

  • quitting smoking self-efficacy

    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 Outcomes (1)

  • efficacy of the game

    1 year

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: QuestionnairesOther: Salvia sample

Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).

EXPERIMENTAL

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

Other: web-based video game (Quit IT)Behavioral: QuestionnairesOther: Salvia sample

Interventions

Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).
QuestionnairesBEHAVIORAL

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.

Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).Standard Care

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.

Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.

Related Links

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jamie Ostroff, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

March 24, 2014

Primary Completion

December 24, 2020

Study Completion

December 24, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations