A Web Site and Print Materials Intervention for Smoking Intervention for Childhood and Young Adult Cancer Survivors (PFH2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Jude Children's Research Hospital
Princess Margaret Hospital, Canada
The Hospital for Sick Children
University of Massachusetts, Amherst
Information provided by (Responsible Party):
Karen Emmons, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00588107
First received: December 24, 2007
Last updated: May 23, 2013
Last verified: May 2013

December 24, 2007
May 23, 2013
September 2005
October 2010   (final data collection date for primary outcome measure)
The primary outcome is smoking cessation [ Time Frame: 15 months post BL ] [ Designated as safety issue: No ]
The primary outcome is smoking cessation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588107 on ClinicalTrials.gov Archive Site
Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy [ Time Frame: 15 months post BL ] [ Designated as safety issue: No ]
Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Web Site and Print Materials Intervention for Smoking Intervention for Childhood and Young Adult Cancer Survivors
Partnership for Health: A Web-Based Smoking Intervention For Cancer Survivors

The purpose of this study is to compare two different ways of helping people who have had childhood cancer, leukemia, tumors or similar illnesses learn health information and information about trying to quit smoking. All participants will get materials in the mail about their health, survivorship, and smoking. Some participants will also be invited to use a website. The goal of the study is to see which is a better way to get information about health issues, survivorship, and smoking.

The proposed study is a randomized controlled trial with two groups. It is designed to demonstrate the efficacy and cost-effectiveness of a Web-based format of the PFH intervention, compared to a written Materials control condition. The study will be conducted among childhood and young adult cancer survivors who smoke at four survivor clinics. Participants in both conditions will receive access to pharmacotherapy at no cost. Participants in the Web condition will receive access to an interactive Web site that focuses on survivorship, health, and smoking.

Participants in the Web condition will receive access to an interactive Web site that focuses on survivorship, health, and smoking. Participants in the Materials control group will receive tailored and targeted print materials.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cancer
  • Other: Web Intervention
    Receives pharmacotherapy and access to an interactive Web site (Web condition). The Web site will offer tailored intervention messages and strategies in an interactive format that is much less labor-intensive and costly than the prior PFH peer telephone counseling intervention.
  • Behavioral: print materials
    tailored print materials designed to aid in smoking reduction and cessation
  • Experimental: Web site access
    Web intervention
    Intervention: Other: Web Intervention
  • Active Comparator: print materials
    Receives tailored print materials and pharmacotherapy (Materials condition)
    Intervention: Behavioral: print materials
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
374
July 2013
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have been diagnosed with cancer before age 35
  • Currently be ≥ 18 years of age and ≤ 55 years of age
  • 2 or more years out of cancer treatment
  • Be mentally capable of providing informed consent
  • Be reachable by telephone for screening and survey completion
  • Be a current smoker (defined as having taken one puff of a cigarette in the last 30 days)
  • Fluent in English

Exclusion Criteria:

  • Currently undergoing active treatment for cancer
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588107
05-032, R01CA106914
No
Karen Emmons, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)
  • St. Jude Children's Research Hospital
  • Princess Margaret Hospital, Canada
  • The Hospital for Sick Children
  • University of Massachusetts, Amherst
Principal Investigator: Karen M Emmons, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP