Smoking Cessation Smartphone App for Cancer Patients (Quit2Heal Study) (Quit2Heal)

Pilot Trial of a Smartphone Smoking Cessation Application Intervention for Cancer Patients (Quit2Heal Study)

The goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app.

Study Overview

• Status: Completed
• Conditions: Smoking; Cancer
• Intervention / Treatment: Behavioral: Experimental smoking cessation smartphone app; Behavioral: Standard of care smoking cessation smartphone app

Detailed Description

Cigarette smoking has harmful effects on cancer patients' treatment and prognosis, but there are systemic barriers to delivering smoking cessation interventions to cancer patients. One solution for addressing these barriers is to give patients immediate access to smoking cessation treatment via a smartphone application. The Quit2Heal smartphone app is engaging and tailored to the specific needs of cancer patients, and can be integrated into routine cancer care. The goal of this study is to determine whether Quit2Heal provides higher quit rates than the current standard smoking cessation app.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18 or older
• diagnosed with cancer in the past 12 months
• has smoked a cigarette (even a puff) in the past 30 days
• interested in learning skills to quit smoking
• willing to be randomly assigned to either smartphone application
• resides in US
• has at least daily access to their own smartphone
• knows how to login and download a smartphone application from the Apple app store or Android Play app store
• willing and able to read in English
• not currently using cessation medications or enrolled in other smoking cessation programs, and
• has never used the NCI's Quit Guide smartphone application.
• willing and able to complete one follow-up survey
• willing to provide email, phone, and mailing address.

Exclusion Criteria:

• The exclusion criteria are opposite of the inclusion criteria listed above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; This is the experimental arm of the study. This includes receiving the novel/experimental smoking cessation smartphone app. Therapy description of experimental app withheld to protect the integrity of the study.	Behavioral: Experimental smoking cessation smartphone app; The experimental arm includes an intervention using a novel/experimental smartphone smoking cessation app.
Active Comparator: Control; This is the control arm of the study. This includes receiving the standard of care smoking cessation smartphone app. Therapy description of standard of care app withheld to protect the integrity of the study.	Behavioral: Standard of care smoking cessation smartphone app; The control intervention uses a standard of care smartphone smoking cessation app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day point prevalence abstinence	No smoking in the past 30 days, as reported 2 months post treatment.	2 months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); CVS Health Foundation

Publications and helpful links

General Publications

• Bricker JB, Watson NL, Heffner JL, Sullivan B, Mull K, Kwon D, Westmaas JL, Ostroff J. A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness. JMIR Form Res. 2020 Jan 17;4(1):e16652. doi: 10.2196/16652.

Helpful Links

• Quit2Heal Study recruitment website

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Smoking cessation; Oncology; App for quitting smoking
• Other Study ID Numbers: 8630; P30CA015704 (U.S. NIH Grant/Contract); NCI-2018-02641 (Registry Identifier: NCI / CTRP); RG1001682 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No