This document outlines a proposed randomized controlled trial to test a game-based coping skills intervention for increasing smoking abstinence in cancer patients following hospitalization. The trial would randomize 190 patients to either usual care plus the game or usual care only and collect data on self-efficacy and smoking at 1, 3, and 6 months. The game is intended to help patients build skills for coping with smoking cues after discharge. The usual care involves standard cessation counseling. Key inclusion criteria are recent cancer diagnosis, tobacco use in past 30 days, and ability to use a computer game. Exclusion criteria include metastatic disease or major psychiatric illness. Measures would assess tobacco use history, coping, urges, and self-efficacy. Risk

1. David Martz
dmartz@muzzylane.com
Quit IT
A Coping Skills Game to Increase Self- Efficacy for Maintaining Smoking Abstinence following Hospitalization

2. •at risk for smoking-related complications
•diminished treatment success
•compromised recovery
70% Continue to smoke despite recent diagnosis
most are able to abstain from smoking during inpatient stays, but …
approximately 40-50% of smokers relapse once they go home.
Patients readily encounter situations that promote continued smoking after hospital discharge (stress, boredom, test results, relatives who smoke )
Tobacco dependent cancer patients

3. Game Based Intervention
Built on MSKCC Therapies
Cessation counseling by trained oncology nurses certified as tobacco treatment specialists (TTS) who follow evidence-based behavioral and pharmacological best practices in treating tobacco dependence.

4. Phase II Protocol
•Randomized trial to test the game’s potential to increase coping self-efficacy and decrease relapse to smoking among hospitalized cancer patients
•Randomize 190 patients using a two-group design (Usual Care + Smoking Cues Coping Skills Game vs. Usual Care Only) and gather self-efficacy and tobacco use data at 1, 3, and 6 months following hospitalization

5. Research Question 1
To ascertain the extent to which the Usual Care + Game Intervention impacts coping self-efficacy in comparison with the Usual Care condition.

6. Research Question 2
To determine whether the addition of the Quit IT game intervention improves smoking cessation and longer- term abstinence rates compared to usual care for cancer patients.

7. Recruitment ProcessandAssumptions
From MSKCC Tobacco Cessation Program
•Internet Access
•Diversity in Clinical Trials
•Patient Privacy

8. Subject Inclusion Criteria
–Age > 18 years old
–English-speaking
–Recent cancer diagnosis (within past six months)
–Scheduled for hospitalization within the next 30 days
–Patient-reported tobacco 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
Subject Exclusion Criteria
–Metastatic disease at the time of enrollment
–Major psychiatric illness that in the judgment of the investigator would preclude study participation
–Cognitive impairment that would impair full participation in the trial assessed by Brief 6-Item Screener of 4 or more incorrect answers.: history of major depression is a known barrier for smoking cessation
–use the PHQ-954 to assess distressed mood and those scoring in the clinical range on the PHQ-9 (above 10) will be referred for treatment and further evaluation.

9. Usual Care Only Group
•Trial participants will receive standard cessation counseling
–self-help print material for tobacco-dependent cancer patients
–individualized recommendations for cessation medication.
•Cessation counseling provided by trained oncology nurses certified as tobacco treatment specialists (TTS)
•Pre-hospitalization counseling session
•Second counseling session
–bedside counseling delivered post-operatively
•Delivered within one month post-discharge, third and fourth counseling sessions
–Conducted by telephone and focus on relapse prevention.

10. Usual Care + Game Group
Patient will be oriented and trained on use of the game by a research study assistant (RSA) using a tablet. The orientation and training session will comprise:
–Overview of the game and its objectives
–Discussion of the rules of the game
–RSA demonstration of the game platform
–Observing the patient engaged in game play and giving feedback on game navigation
–Answering all patient questions
–Evaluation of the patient’s capacity and comprehension of gameplay.

11. Assessment / Evaluation Plan
•Standard, reliable measurement instruments commonly used in tobacco cessation research.
•Measures to be completed in-person at time of recruitment with the RSA. At 1, 3, and 6 months following the intervention, participants will complete tobacco use, coping, and self-efficacy measures.

12. At Baseline and Follow Up:
•Tobacco Use History and Nicotine Dependence
–standard items assessing lifetime and current smoking pattern (daily, occasionally, not at all), number of cigarettes smoked daily, years of regular smoking, Nicotine dependence
–assessed with the FagerstromTest of Nicotine Dependence
•SociodemographicCharacteristics.
–Age, sex, ethnicity, years in US, education, occupation, and comorbid medical conditions assessed at baseline only.

13. OtherMeasures
•Medical, Disease, and Treatment Variables.
•Smoking Urges
•Coping with Smoking Urges.
•Smoking Cessation Self-Efficacy.
•Because history of major depression is a known barrier for smoking cessation53 we will use the PHQ-954 to assess distressed mood.
•Use and Evaluation–of the Game

14. Protection of Human Subjects
•distress secondary to discussion of illness and smoking history
•breaches of confidentiality
Potential risks for participants in this study:

15. David Martz
dmartz@muzzylane.com