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
  Purpose

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.


Condition Intervention
Cancer
Other: Web Intervention
Behavioral: print materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Partnership for Health: A Web-Based Smoking Intervention For Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • The primary outcome is smoking cessation [ Time Frame: 15 months post BL ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 374
Study Start Date: September 2005
Estimated Study Completion Date: July 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web site access
Web intervention
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 pharmacotherapy (Materials condition)
Behavioral: print materials
tailored print materials designed to aid in smoking reduction and cessation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588107

Locations
United States, Massachusetts
DFCI
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
St. Jude Children's Research Hospital
Princess Margaret Hospital, Canada
The Hospital for Sick Children
University of Massachusetts, Amherst
Investigators
Principal Investigator: Karen M Emmons, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

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
Study First Received: December 24, 2007
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Cancer
Smoker
Web based intervention
Partnership for Health
Cancer Survivors

ClinicalTrials.gov processed this record on July 23, 2014