Newly Diagnosed Cancer PatientsNCT00575718
Smoking Cessation Intervention for Cancer Patients
A study testing Hospital Counseling + Nicotine Replacement Therapy. questionaires and Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires in people with Newly Diagnosed Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if we can find ways to improve the treatment of tobacco dependence in patients who have cancer or may have cancer. We will compare two ways to help people quit tobacco use before surgery and to stay quit after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Cancer Patients
- What is being tested?
- Hospital Counseling + Nicotine Replacement Therapy. questionaires and Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2002to 18 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Smokers who typically smoke > 8 cigarettes per day who have smoked within the last 7 days or other tobacco users with high frequency of use (> 8 per day) within the last 7 days;
- Diagnosed with cancer or have a mass suspicious of cancer that is NOT distant metastatic cancer at the time of enrollment;
- Likely candidate for surgical treatment no sooner than 7 days from study entry;
- Absence of gross psychopathology or cognitive impairment;
- Can be reached by telephone;
- Have manual dexterity and sensory (i.e., visual and auditory) acuity sufficient to use a Personal Digital Assistant (PDA);
- Provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Presurgical Smoking Cessation Intervention for Cancer Patients: The Resolve Study
The purpose of this study is to see if we can find ways to improve the treatment of tobacco dependence in patients who have cancer or may have cancer. We will compare two ways to help people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled reduced smoking program followed by use of the nicotine patch. In this program, the tobacco user will gradually cut down on their tobacco use until they quit. Once they quit, they will be offered the nicotine patch. We will compare this approach to our current program of counseling and use of nicotine patch. What we learn from this study may help us to develop new ways to help tobacco users and improve our current smoking cessation program.
Read the detailed description
Smoking cessation offers an important way for newly diagnosed cancer patients to take an active role in their treatment and recovery. Quitting tobacco use decreases cancer patients' risk of disease recurrence and development of second primary cancers. In addition, preoperative tobacco cessation may reduce the likelihood of perioperative pulmonary, cardiovascular, and wound healing complications. Due to increased awareness of the health hazards of tobacco use, rates of cessation after cancer diagnosis are high. However, 35% to 69% of patients continue to use tobacco and this is largely due to strong barriers to quitting (low-self efficacy, psychological distress) rather than lack of positive intentions to quit. Previous attempts to increase smoking cessation among the medically ill have provided intervention either during or after hospitalization.
We propose that the period immediately prior to hospitalization and surgery represents a unique window of opportunity, or "teachable moment," for smoking cessation that could take full advantage of patients' enhanced health awareness and quitting motivation, strong physician quitting advice, and patients' heightened desire to take an active role in their care.
- Conditions
- Newly Diagnosed Cancer Patients
- Being tested
- Hospital Counseling + Nicotine Replacement Therapy. questionaires, Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires
- Keywords
- Quitting tobacco, tobacco use
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Counseling + Nicotine Replacement Therapy. questionairesBehavioural
brief face-to-face or telephone tobacco cessation counseling provided by a tobacco cessation specialist prior to admission and during hospitalization (15-20 minutes per encounter)provision of multi-media self-help materials (e.g., "Smoking Cessation Guide for Cancer Patients and Their Families") tailored to address cancer-specific issues such as the benefits and barriers of quitting for cancer patients; 3) tobacco cessation pharmacotherapy, unless medically contraindicated (for this study we will standardize the pharmacotherapy as transdermal nicotine patch), and; 4) two brief telephone counseling (15 minutes) sessions completed as seen clinically appropriate by the tobacco cessation specialists. The content of these counseling sessions is based on the patient's smoking status.
Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionairesBehavioural
Same components of HC+NRT as well as the PS/SRS enhancement.The research team will provide education about scheduled reduced smoking either in person or over the phone. Purpose of the training session, will be audio taped, to prepare participants for daily PDA use over the dur of the scheduled-reduced smoking intervention. Training will demonstrate use of PDA and simulate common technical and procedural issues that might arise during the intervention (e.g., forgetting to record a cigarette or wake time; repeating a day's schedule if needed, prior to the quit date). The simulation will reflect anticipated problems and those identified by users of the PDA. A study helpline number and instructional manual will be provided. A member of the research staff will contact the study participants, once the reduced smoking schedule has begun, to check that the patient understands the schedule and that the PDA is working properly. Estimate patient training with the PDA will require 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Hospital Counseling + Nicotine Replacement Therapy (HC+NRT) Receives: Behavioral: Hospital Counseling + Nicotine Replacement Therapy. questionaires |
| 2 | Experimental | Hospital Counseling + Nicotine Replacement Therapy + Pre-surgical Schedule Reduced Smoking (HC+NRT+PS/SRS) Receives: Behavioral: Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of a presurgical smoking cessation intervention that adds scheduled reduced smoking, a highly effective behavioral treatment in non-medically ill tobacco users, to enhanced usual care, i.e., hospital counseling and nicotine replacement therapy.
Measured: will be measured at hospital admission, and 3 and 6 months post-hospital admission.
Secondary outcomes (1)
whether addition of a presurgical scheduled reduced smoking intervention improves smoking cessation and long-term abstinence rates c/w hospital counseling and nicotine transdermal patch (enhanced usual care) for recently diagnosed cancer patients.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study start22 Oct 2002
- Primary completion18 Sep 2027 (estimated)
- Study completion18 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575718
- Sponsor's protocol ID
- 02-094
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2007
- Last updated
- 5 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Smoking Cessation Intervention for Cancer Patients: The Resolve Study
- ClinicalTrials.gov ID
- NCT00575718
- Acronym / sponsor ID
- 02-094
- Conditions
- Newly Diagnosed Cancer Patients
- Keywords
- Quitting tobacco, tobacco use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 22 Oct 2002 (actual)
- Primary completion
- 18 Sep 2027 (estimated)
- Study completion
- 18 Sep 2027 (estimated)
- First posted
- 18 Dec 2007 (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 is to see if we can find ways to improve the treatment of tobacco dependence in patients who have cancer or may have cancer. We will compare two ways to help people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled reduced smoking program followed by use of the nicotine patch. In this program, the tobacco user will gradually cut down on their tobacco use until they quit. Once they quit, they will be offered the nicotine patch. We will compare this approach to our current program of counseling and use of nicotine patch. What we learn from this study may help us to develop new ways to help tobacco users and improve our current smoking cessation program.
Detailed description
Smoking cessation offers an important way for newly diagnosed cancer patients to take an active role in their treatment and recovery. Quitting tobacco use decreases cancer patients' risk of disease recurrence and development of second primary cancers. In addition, preoperative tobacco cessation may reduce the likelihood of perioperative pulmonary, cardiovascular, and wound healing complications. Due to increased awareness of the health hazards of tobacco use, rates of cessation after cancer diagnosis are high. However, 35% to 69% of patients continue to use tobacco and this is largely due to strong barriers to quitting (low-self efficacy, psychological distress) rather than lack of positive intentions to quit. Previous attempts to increase smoking cessation among the medically ill have provided intervention either during or after hospitalization.
We propose that the period immediately prior to hospitalization and surgery represents a unique window of opportunity, or "teachable moment," for smoking cessation that could take full advantage of patients' enhanced health awareness and quitting motivation, strong physician quitting advice, and patients' heightened desire to take an active role in their care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Hospital Counseling + Nicotine Replacement Therapy. questionairesHospital Counseling + Nicotine Replacement Therapy (HC+NRT) |
| 2 | Experimental | Behavioral: Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionairesHospital Counseling + Nicotine Replacement Therapy + Pre-surgical Schedule Reduced Smoking (HC+NRT+PS/SRS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Smokers who typically smoke > 8 cigarettes per day who have smoked within the last 7 days or other tobacco users with high frequency of use (> 8 per day) within the last 7 days;
- Diagnosed with cancer or have a mass suspicious of cancer that is NOT distant metastatic cancer at the time of enrollment;
- Likely candidate for surgical treatment no sooner than 7 days from study entry;
- Absence of gross psychopathology or cognitive impairment;
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 |
|---|---|---|
| Hospital Counseling + Nicotine Replacement Therapy. questionairesbrief face-to-face or telephone tobacco cessation counseling provided by a tobacco cessation specialist prior to admission and during hospitalization (15-20 minutes per encounter)provision of multi-media self-help materials (e.g., "Smoking Cessation Guide for Cancer Patients and Their Families") tailored to address cancer-specific issues such as the benefits and barriers of quitting for cancer patients; 3) tobacco cessation pharmacotherapy, unless medically contraindicated (for this study we will standardize the pharmacotherapy as transdermal nicotine patch), and; 4) two brief telephone counseling (15 minutes) sessions completed as seen clinically appropriate by the tobacco cessation specialists. The content of these counseling sessions is based on the patient's smoking status. | Behavioural | 1 |
| Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionairesSame components of HC+NRT as well as the PS/SRS enhancement.The research team will provide education about scheduled reduced smoking either in person or over the phone. Purpose of the training session, will be audio taped, to prepare participants for daily PDA use over the dur of the scheduled-reduced smoking intervention. Training will demonstrate use of PDA and simulate common technical and procedural issues that might arise during the intervention (e.g., forgetting to record a cigarette or wake time; repeating a day's schedule if needed, prior to the quit date). The simulation will reflect anticipated problems and those identified by users of the PDA. A study helpline number and instructional manual will be provided. A member of the research staff will contact the study participants, once the reduced smoking schedule has begun, to check that the patient understands the schedule and that the PDA is working properly. Estimate patient training with the PDA will require 30 minutes. | Behavioural | 2 |
Primary outcome
efficacy of a presurgical smoking cessation intervention that adds scheduled reduced smoking, a highly effective behavioral treatment in non-medically ill tobacco users, to enhanced usual care, i.e., hospital counseling and nicotine replacement therapy.
Time frame: will be measured at hospital admission, and 3 and 6 months post-hospital admission.
1 secondary outcome
whether addition of a presurgical scheduled reduced smoking intervention improves smoking cessation and long-term abstinence rates c/w hospital counseling and nicotine transdermal patch (enhanced usual care) for recently diagnosed cancer patients.
Time frame: 6-8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Related InfoLink provided by the sponsor.
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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.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering 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 Hospital Counseling + Nicotine Replacement Therapy. questionaires and Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires in people with Newly Diagnosed Cancer Patients, run by Memorial Sloan Kettering 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 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
efficacy of a presurgical smoking cessation intervention that adds scheduled reduced smoking, a highly effective behavioral treatment in non-medically ill tobacco users, to enhanced usual care, i.e., hospital counseling and nicotine replacement therapy. (time frame: will be measured at hospital admission, and 3 and 6 months post-hospital admission.). 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 5 Oct 2026.