Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Memorial Sloan Kettering Cancer Center.
Sponsor:
Collaborators:
New York University
Muzzy Lane Software
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier:
NCT02099097
First received: March 25, 2014
Last updated: February 12, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Other: web-based video game (Quit IT)
Behavioral: Questionnaires
Other: Salvia sample

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • quitting smoking self-efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    as measured by the Confidence Questionnaire to assess changes in confidence in being able to resist urges to smoke across everyday situations.


Secondary Outcome Measures:
  • efficacy of the game [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 and 3 months following enrollment. We will also biochemically verify 7-day point prevalence smoking abstinence at the 3 month follow-up assessment.


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
4 cessation counseling telephone (or face to face) sessions, self-help material written for tobacco-dependent cancer pts & individualized recommendations for cessation medication. Cessation counseling will be provided by trained oncology nurses certified as tobacco treatment specialists (TTS) who follow evidence based behavioral & pharmacological best practices in treating tobacco dependence. After consent the initial counseling session focuses on motivation-building, choosing a quit date, reviewing the self-help guide, & education about cessation pharmacotherapies. 2nd counseling session will focus on coping with smoking urges & preventing smoking relapse. W/I 1 month following hospitalization, the 3rd & 4th counseling sessions focus on relapse prevention or recycling to a repeat quit attempt for those who have resumed smoking. The end of each session the TTS a counseling checklist outlining the goals of each session. Checklist will assist the TTS in tracking pt fidelity.
Behavioral: Questionnaires Other: Salvia sample
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
Other: web-based video game (Quit IT) Behavioral: Questionnaires Other: Salvia sample

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • English-speaking
  • Cancer (solid tumor) diagnosis mass suspicious of cancer within past six months
  • 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:

  • Metastatic disease at the time of enrollment
  • Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
  • Patients' whose hospital admission is scheduled within the next 48 hours from time of chart screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099097

Contacts
Contact: Jamie Ostroff, PhD 646-888-0041
Contact: Jack Burkhalter, PhD 646-888-0040

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jamie Ostroff, PhD    646-888-0041      
Contact: Jack Burkhalter    646-888-0040      
Principal Investigator: Jamie Ostroff, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
New York University
Muzzy Lane Software
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier: NCT02099097     History of Changes
Other Study ID Numbers: 14-062
Study First Received: March 25, 2014
Last Updated: February 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
3D Coping Skills Game
Quit smoking
14-062

ClinicalTrials.gov processed this record on February 25, 2015