games for health - david martz - clinical trials to measure the efficacy of a 3d game-based...

David Martzdmartz@muzzylane.com

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 Martzdmartz@muzzylane.com