CancerNCT07072312
Feasibility, Acceptability and Fidelity of Integrating a Navigation Intervention Into Tobacco Treatment Program
A study testing Adjuvant Patient Navigation for Tobacco Treatment in people with Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Patient Navigation is being included as part of a tobacco treatment program for cancer patients to help patients overcome barriers to quitting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Adjuvant Patient Navigation for Tobacco Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 27 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a cancer diagnosis. Patients may be undergoing active therapy or may have completed treatment.
- English speaking.
- Age > 18 years.
- Active tobacco cigarette user, defined as having smoked a cigarette within the 30 days prior to enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Feasibility, Acceptability and Fidelty of Integrating Navigation to Improve Adherence: Tobacco Treatment Program for Cancer Patients A Pragmatic Pilot Study
Patient Navigation is being included as part of a tobacco treatment program for cancer patients to help patients overcome barriers to quitting.
Read the detailed description
The primary objective of this prospective, interventional pilot study is to assess the feasibility, acceptability and fidelity of a navigation intervention embedded into the clinical Tobacco Treatment Program.
The investigators will employ a pre-post design with two cohorts (30 to the pre-intervention, and 90 to the intervention, respectively) to address the specific aims of the study.
- Conditions
- Cancer
- Being tested
- Adjuvant Patient Navigation for Tobacco Treatment
- Keywords
- Tobacco Cessation, Patient Navigation
- Medical subject headings
- Neoplasms, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Patient Navigation for Tobacco TreatmentBehavioural
Patients in the study meet with the Patient Navigator two weeks after their first tobacco treatment visit and again after their second visit with the Tobacco Treatment Provider. The Patient Navigator will discuss psychosocial and other cessation barriers. The Patient Navigator will connect the patients with appropriate resources to help overcome these barriers.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation | Experimental | Participants receive patient navigation after their first and second tobacco treatment visits. Receives: Behavioral: Adjuvant Patient Navigation for Tobacco Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Integrating Navigation into Tobacco Treatment Program
The number of patients who enroll and consent to receiving the tobacco treatment program navigation intervention. Feasibility will be obtained if at least 60% consent and enroll.
Measured: Prior to first TTP visit - consented and enrolled
Patient Acceptability of Navigation in Tobacco Treatment - Patient Recommendation
The number of patients who state they would likely or highly likely to recommend the service to other cancer patients. Acceptability will obtained if 70% of patients likely recommend the service.
Measured: One and six months post initial navigation intervention
Provider Implementation of the Intervention -Fidelity to Protocol
The number of patients who receive the two primary components of the navigation intervention, assessing tobacco cessation barriers and psychosocial barriers. Fidelity will be achieved if 80% of cases include both elements measured through a review of the navigation case management system.
Measured: Baseline to 6 months
Fidelity of Utilization of Navigation Intervention - Patient Participation
Number of patients who had at least 2 navigation encounters. Fidelity will be achieved if 80% of patients have a minimum of 2 navigation encounters through the navigation case management review.
Measured: Baseline to 6 months
Secondary outcomes (1)
7-Day Point Prevalence
7-Day point prevalence of tobacco will be assessed at six month follow up.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Nov 2022
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The first 30 patients are enrolled to the pre-intervention group and receive standard of care to serve as a comparison group. The subsequent patients are enrolled to the single arm to receive the standard care and patient navigation intervention.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Principal investigator, Linda Fleisher, Fox Chase Cancer Center
- Investigators
- Linda Fleisher, PhD, MPH, Principal investigator, Temple Univeristy Health System - Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072312
- Sponsor's protocol ID
- 22-1011
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Fidelty of Integrating Navigation to Improve Adherence: Tobacco Treatment Program for Cancer Patients A Pragmatic Pilot Study
- ClinicalTrials.gov ID
- NCT07072312
- Acronym / sponsor ID
- 22-1011
- Conditions
- Cancer
- Keywords
- Tobacco Cessation, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 18 Jul 2025 (actual)
- 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.
Patient Navigation is being included as part of a tobacco treatment program for cancer patients to help patients overcome barriers to quitting.
Detailed description
The primary objective of this prospective, interventional pilot study is to assess the feasibility, acceptability and fidelity of a navigation intervention embedded into the clinical Tobacco Treatment Program.
The investigators will employ a pre-post design with two cohorts (30 to the pre-intervention, and 90 to the intervention, respectively) to address the specific aims of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The first 30 patients are enrolled to the pre-intervention group and receive standard of care to serve as a comparison group. The subsequent patients are enrolled to the single arm to receive the standard care and patient navigation intervention.
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Experimental | Behavioral: Adjuvant Patient Navigation for Tobacco TreatmentParticipants receive patient navigation after their first and second tobacco treatment visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a cancer diagnosis. Patients may be undergoing active therapy or may have completed treatment.
- English speaking.
- Age > 18 years.
- Active tobacco cigarette user, defined as having smoked a cigarette within the 30 days prior to enrollment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adjuvant Patient Navigation for Tobacco TreatmentPatients in the study meet with the Patient Navigator two weeks after their first tobacco treatment visit and again after their second visit with the Tobacco Treatment Provider. The Patient Navigator will discuss psychosocial and other cessation barriers. The Patient Navigator will connect the patients with appropriate resources to help overcome these barriers. | Behavioural | Patient Navigation |
Primary outcome
Feasibility of Integrating Navigation into Tobacco Treatment Program
Time frame: Prior to first TTP visit - consented and enrolled
The number of patients who enroll and consent to receiving the tobacco treatment program navigation intervention. Feasibility will be obtained if at least 60% consent and enroll.
Patient Acceptability of Navigation in Tobacco Treatment - Patient Recommendation
Time frame: One and six months post initial navigation intervention
The number of patients who state they would likely or highly likely to recommend the service to other cancer patients. Acceptability will obtained if 70% of patients likely recommend the service.
Provider Implementation of the Intervention -Fidelity to Protocol
Time frame: Baseline to 6 months
The number of patients who receive the two primary components of the navigation intervention, assessing tobacco cessation barriers and psychosocial barriers. Fidelity will be achieved if 80% of cases include both elements measured through a review of the navigation case management system.
Fidelity of Utilization of Navigation Intervention - Patient Participation
Time frame: Baseline to 6 months
Number of patients who had at least 2 navigation encounters. Fidelity will be achieved if 80% of patients have a minimum of 2 navigation encounters through the navigation case management review.
1 secondary outcome
7-Day Point Prevalence
Time frame: Six months
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 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Linda Fleisher, PhD, MPH principal investigator
Temple Univeristy Health System - Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant Patient Navigation for Tobacco Treatment in people with Cancer, run by Fox Chase Cancer Center 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 4 inclusion and 0 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 18 Jul 2025. 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?
Feasibility of Integrating Navigation into Tobacco Treatment Program (time frame: Prior to first TTP visit - consented and enrolled). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.