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

December 30, 2014 updated by: Karen Emmons, PhD, Dana-Farber Cancer Institute

Partnership for Health: A Web-Based Smoking Intervention For Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • DFCI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is smoking cessation
Time Frame: 15 months post BL
15 months post BL

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
The Hospital for Sick Children
St. Jude Children's Research Hospital
University of Massachusetts, Amherst
Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Karen M Emmons, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 24, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05-032
  • R01CA106914 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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