NCT04914000

Brief Summary

This study will assess feasibility and acceptability of an intervention designed to increase smoking cessation motivation among patients with a cancer not widely known to be smoking related.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 25, 2023

Completed
Last Updated

April 25, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

April 12, 2019

Results QC Date

February 27, 2023

Last Update Submit

April 3, 2023

Conditions

CancerSmoking

Outcome Measures

Primary Outcomes (6)

  • Number of Participants Who Consent to Participate in the Study- Feasibility

    Number of participants who consent to participate in the study

    Baseline

  • Number of Participants That Complete 1-week Follow-up Assessments - Feasibility

    Number of participants who complete 1-week follow-up assessments

    1-week post-treatment

  • Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility

    Number of participants who complete 1-month follow-up assessments

    1-month post-treatment

  • Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment

    Number of study participants who read the booklet

    1-week post-treatment

  • Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment

    Number of study participants who read the booklet

    1-month post-treatment

  • Acceptability

    Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire, values between 8 and 32, with higher scores mean a better outcome.

    1-month post-treatment

Secondary Outcomes (11)

  • Motivation to Quit Smoking Assessed With the Contemplation Ladder

    Baseline, 1-week post-treatment, 1-month post-treatment

  • Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME).

    Baseline, 1-week post-treatment, 1-month post-treatment

  • Participants Change in Motivation - Action Stage

    Baseline, at 1 week and 1 month post treatment

  • Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website

    1-month post-treatment

  • Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week

    At 1 Week Post Treatment

  • +6 more secondary outcomes

Study Arms (1)

Self Help Materials

EXPERIMENTAL

Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type.

Behavioral: Self-help Materials

Interventions

Self-help MaterialsBEHAVIORAL

Self-help booklet targeted by cancer type to increase smoking cessation motivation

Self Help Materials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking at least 1 cigarette in previous 30 days
  • Diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer within the last 6 months
  • Able to read/write English
  • Able to give informed consent
  • Not currently enrolled in a smoking cessation program

You may not qualify if:

  • Having distant metastases
  • Male patients with breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Ursula Martinez
Organization
Moffitt Cancer Center
Ursula.Martinez@moffitt.org
813-745-1754

Study Officials

  • Ursula Martinez, Ph.D.

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

June 4, 2021

Study Start

June 14, 2021

Primary Completion

April 13, 2022

Study Completion

June 2, 2022

Last Updated

April 25, 2023

Results First Posted

April 25, 2023

Record last verified: 2023-02

Locations

US(1)