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

Cancer Clinical Trial

— PFH2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588107
• Other study ID #: 05-032
• Secondary ID: R01CA106914
• Status: Completed
• Phase: N/A
• First received: December 24, 2007
• Last updated: December 30, 2014
• Start date: September 2005
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: December 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

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.

Behavioral:
• print materials
tailored print materials designed to aid in smoking reduction and cessation

Locations

Country	Name	City	State
United States	DFCI	Boston	Massachusetts

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

References & Publications (7)

de Moor JS, Puleo E, Ford JS, Greenberg M, Hodgson DC, Tyc VL, Ostroff J, Diller LR, Levy AG, Sprunck-Harrild K, Emmons KM. Disseminating a smoking cessation intervention to childhood and young adult cancer survivors: baseline characteristics and study design of the partnership for health-2 study. BMC Cancer. 2011 May 11;11:165. doi: 10.1186/1471-2407-11-165. — View Citation

Emmons KM, Puleo E, Sprunck-Harrild K, Ford J, Ostroff JS, Hodgson D, Greenberg M, Diller L, de Moor J, Tyc V. Partnership for health-2, a web-based versus print smoking cessation intervention for childhood and young adult cancer survivors: randomized com — View Citation

Emmons KM, Sprunck-Harrild K, Puleo E, de Moor J. Provider advice about smoking cessation and pharmacotherapy among cancer survivors who smoke: practice guidelines are not translating. Transl Behav Med. 2013 Jun;3(2):211-7. doi: 10.1007/s13142-013-0202-7. — View Citation

Ford JS, Puleo E, Sprunck-Harrild K, deMoor J, Emmons KM. Perceptions of risk among childhood and young adult cancer survivors who smoke. Support Care Cancer. 2014 Aug;22(8):2207-17. — View Citation

Nagler RH, Puleo E, Sprunck-Harrild K, Emmons KM. Internet use among childhood and young adult cancer survivors who smoke: implications for cessation interventions. Cancer Causes Control. 2012 Apr;23(4):647-52. doi: 10.1007/s10552-012-9926-9. Epub 2012 Feb 28. — View Citation

Nagler RH, Puleo E, Sprunck-Harrild K, Viswanath K, Emmons KM. Health media use among childhood and young adult cancer survivors who smoke. Support Care Cancer. 2014 Sep;22(9):2497-507. doi: 10.1007/s00520-014-2236-x. Epub 2014 Apr 13. — View Citation

Tyc VL, Puleo E, Emmons K, de Moor JS, Ford JS. Smoking Restrictions Among Households of Childhood and Young Adult Cancer Survivors: Implications for Tobacco Control Efforts. J Adolesc Young Adult Oncol. 2013 Mar;2(1):17-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is smoking cessation		15 months post BL	No
Secondary	Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy		15 months post BL	No