CancerPFH2NCT00588107
A Web Site and Print Materials Intervention for Smoking Intervention for Childhood and Young Adult Cancer Survivors
A study testing Web Intervention and print materials in people with Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cancer
- What is being tested?
- Web Intervention and print materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Currently undergoing active treatment for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Web Intervention, print materials
- Keywords
- Cancer, Smoker, Web based intervention, Partnership for Health, Cancer Survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web InterventionOther
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.
print materialsBehavioural
tailored print materials designed to aid in smoking reduction and cessation
| Study group | Role | What they receive |
|---|---|---|
| Web site access | Experimental | Web intervention- and access to pharmacotherapy Receives: Other: Web Intervention |
| print materials | Active comparator | Receives tailored print materials and access to pharmacotherapy (Materials condition) Receives: Behavioral: print materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is smoking cessation
Measured: 15 months post BL
Secondary outcomes (1)
Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy
Measured: 15 months post BL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionOct 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, Princess Margaret Hospital, Canada, The Hospital for Sick Children, University of Massachusetts, Amherst
- Responsible party
- Principal investigator, Karen Emmons, PhD, Dana-Farber Cancer Institute
- Investigators
- Karen M Emmons, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588107
- Sponsor's protocol ID
- 05-032
- Other IDs
- R01CA106914
- Acronym
- PFH2
- Status last verified
- Dec 2014
- First submitted
- 24 Dec 2007
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21569345Nagler 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.
PubMed 22370697Tyc 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. doi: 10.1089/jayao.2012.0019.
PubMed 23610739Nagler 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.
PubMed 24728617Ford 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. doi: 10.1007/s00520-014-2165-8.
PubMed 24659242Emmons 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.
PubMed 23894256Emmons 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 comparative effectiveness study. J Med Internet Res. 2013 Nov 5;15(11):e218. doi: 10.2196/jmir.2533.
PubMed 24195867
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership for Health: A Web-Based Smoking Intervention For Cancer Survivors
- ClinicalTrials.gov ID
- NCT00588107
- Acronym / sponsor ID
- PFH2 / 05-032
- Conditions
- Cancer
- Keywords
- Cancer, Smoker, Web based intervention, Partnership for Health, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, Princess Margaret Hospital, Canada, The Hospital for Sick Children, University of Massachusetts, Amherst
- Study start
- Sep 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web site access | Experimental | Other: Web InterventionWeb intervention- and access to pharmacotherapy |
| print materials | Active comparator | Behavioral: print materialsReceives tailored print materials and access to pharmacotherapy (Materials condition) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Currently undergoing active treatment for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web InterventionReceives 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. | Other | Web site access |
| print materialstailored print materials designed to aid in smoking reduction and cessation | Behavioural | print materials |
Primary outcome
The primary outcome is smoking cessation
Time frame: 15 months post BL
1 secondary outcome
Secondary outcome: cost-effectiveness, intervention dose delivered, reach, impact, quit attempts, motivation to quit, and use of pharmacotherapy
Time frame: 15 months post BL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Background: PubMed 21569345de 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.
- Background: PubMed 22370697Nagler 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.
- Background: PubMed 23610739Tyc 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. doi: 10.1089/jayao.2012.0019.
- Background: PubMed 24728617Nagler 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.
- Background: PubMed 24659242Ford 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. doi: 10.1007/s00520-014-2165-8.
- Results publication: PubMed 23894256Emmons 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.
- Results publication: PubMed 24195867Emmons 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 comparative effectiveness study. J Med Internet Res. 2013 Nov 5;15(11):e218. doi: 10.2196/jmir.2533.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Emmons, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Intervention and print materials in people with Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is smoking cessation (time frame: 15 months post BL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00588107, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.