Trial Outcomes & Findings for Assessment of a Teachable Moment for Smoking Cessation (NCT NCT00596440)

NCT ID: NCT00596440

Last Updated: 2015-08-28

Results Overview

Show rate to eligibility visit

• Recruitment status: COMPLETED
• Target enrollment: 234 participants
• Primary outcome timeframe: week zero
• Results posted on: 2015-08-28

Participant Flow

Participant milestones

Measure	Relatives of Cancer Patients Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.	Relatives of Orthopedic Patients Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
Overall Study STARTED	113	121
Overall Study Showed to Eligibility Visit	85	72
Overall Study Showed to First Treatment Session	61	52
Overall Study COMPLETED	48	41
Overall Study NOT COMPLETED	65	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of a Teachable Moment for Smoking Cessation

Baseline characteristics by cohort

Measure	Relatives of Cancer Patients n=113 Participants Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.	Relatives of Orthopedic Patients n=121 Participants Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling	Total n=234 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 11.7 • n=5 Participants	49.2 years STANDARD_DEVIATION 11.7 • n=7 Participants	47.0 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	70 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: week zero

Show rate to eligibility visit

Outcome measures

Measure	Relatives of Cancer Patients n=113 Participants Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.	Relatives of Orthopedic Patients n=121 Participants Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
Accrual Rate (Eligibility Visit)	85 participants	72 participants

SECONDARY outcome

Timeframe: week nine

Population: The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.

Outcome measures

Measure	Relatives of Cancer Patients n=67 Participants Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.	Relatives of Orthopedic Patients n=61 Participants Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
Smoking Cessation Rate	13 participants	16 participants

SECONDARY outcome

Timeframe: week one

Population: This analysis includes only a subset of participants who had not discontinued the study by week 1.

Outcome measures

Measure	Relatives of Cancer Patients n=112 Participants Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.	Relatives of Orthopedic Patients n=117 Participants Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
Show Rate at First Treatment Session	61 participants	52 participants

Adverse Events

Relatives of Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relatives of Orthopedic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Schnoll

University of Pennsylvania

Phone: 215-746-7143

Email: schnoll@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place