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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588107
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : December 31, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study was 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 received materials in the mail about their health, survivorship, and smoking. Some participants were also invited to use a website. The goal of the study was to see which is a better way to get information about health issues, survivorship, and smoking.

Condition or disease Intervention/treatment
Cancer Other: Web Intervention Behavioral: print materials

Detailed Description:

The study was a randomized controlled trial with two groups. It was 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 was conducted among childhood and young adult cancer survivors, who smoke, at four survivor clinics. Participants in both conditions received access to pharmacotherapy at no cost. Participants in the Web condition received access to an interactive Web site that focuses on survivorship, health, and smoking.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Partnership for Health: A Web-Based Smoking Intervention For Cancer Survivors
Study Start Date : September 2005
Primary Completion Date : October 2010
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Web site access
Web intervention- and access to pharmacotherapy
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.
Active Comparator: print materials
Receives tailored print materials and access to pharmacotherapy (Materials condition)
Behavioral: print materials
tailored print materials designed to aid in smoking reduction and cessation

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome is smoking cessation [ Time Frame: 15 months post BL ]

Secondary Outcome Measures :
  1. Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy [ Time Frame: 15 months post BL ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588107

United States, Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
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
More Information


Responsible Party: Karen Emmons, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00588107     History of Changes
Other Study ID Numbers: 05-032
R01CA106914 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Karen Emmons, PhD, Dana-Farber Cancer Institute:
Web based intervention
Partnership for Health
Cancer Survivors