Trial Outcomes & Findings for Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy (NCT NCT04899492)
NCT ID: NCT04899492
Last Updated: 2026-08-07
Results Overview
Number of patients who completed all planned sessions out of the total number of patients randomised to each group
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
12 months
Results posted on
2026-08-07
Participant Flow
Participant milestones
| Measure |
Group 1:Nicotine Replacement Therapy (NRT)
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 2:Motivational Interviewing (MI)
Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 3:Cognitive Behavioural Therapy (CBT)
Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT): 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 4: Hypnotherapy
Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Hypnotherapy: About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1:Nicotine Replacement Therapy (NRT)
n=6 Participants
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 2:Motivational Interviewing (MI)
n=3 Participants
Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 3:Cognitive Behavioural Therapy (CBT)
n=6 Participants
Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT): 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 4: Hypnotherapy
n=6 Participants
Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Hypnotherapy: About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of patients who completed all planned sessions out of the total number of patients randomised to each group
Outcome measures
| Measure |
Group 1:Nicotine Replacement Therapy (NRT)
n=6 Participants
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 2:Motivational Interviewing (MI)
n=3 Participants
Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 3:Cognitive Behavioural Therapy (CBT)
n=6 Participants
Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT): 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 4: Hypnotherapy
n=6 Participants
Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Hypnotherapy: About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
|---|---|---|---|---|
|
Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1:Nicotine Replacement Therapy (NRT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Group 2:Motivational Interviewing (MI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3:Cognitive Behavioural Therapy (CBT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Group 4: Hypnotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1:Nicotine Replacement Therapy (NRT)
n=6 participants at risk
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 2:Motivational Interviewing (MI)
n=3 participants at risk
Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 3:Cognitive Behavioural Therapy (CBT)
n=6 participants at risk
Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT): 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
Group 4: Hypnotherapy
n=6 participants at risk
Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after
Motivational Interviewing (MI): 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Hypnotherapy: About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT): All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Asthenia
|
0.00%
0/6 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/6 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/6 • 12 months
|
0.00%
0/3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Additional Information
Dr Sandrine HIRET
Institut de Cancérologie de l'Ouest
Phone: +33 2 40 67 99 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place