games for health - david martz - clinical trials to measure the efficacy of a 3d game-based...
TRANSCRIPT
David [email protected]
Quit IT
A Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking
Abstinence following Hospitalization
• 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
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.
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
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.
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.
Recruitment Process and Assumptions
From MSKCC Tobacco Cessation Program
• Internet Access
• Diversity in Clinical Trials
• Patient Privacy
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.
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.
Usual Care + Game GroupPatient 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.
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.
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 Fagerstrom Test of Nicotine Dependence
• SociodemographicCharacteristics.
– Age, sex, ethnicity, years in US, education, occupation, and comorbid medical conditions assessed at baseline only.
Other Measures
• 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
Protection of Human Subjects
• distress secondary to discussion of illness and smoking history
• breaches of confidentiality
Potential risks for participants in this study:
David [email protected]