NCT05370859

Brief Summary

The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

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 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

April 27, 2022

Last Update Submit

April 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants who enroll in cessation services

    Assessed using administrative records

    12 weeks after study start

Secondary Outcomes (3)

  • Level of and change in motivation and self-efficacy to quit smoking

    Through study completion, an average of 12 weeks

  • Level of and change in anxiety and depression

    Through study completion, an average of 12 weeks

  • Number of smoking quit attempts

    12 weeks after study start

Study Arms (1)

Mme Study Participants

Participants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks

Other: There is no intervention for this study

Interventions

There is no intervention or exposure for this study

Mme Study Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being seen at the study recruitment sites for cancer treatment, who have a current cancer diagnosis and who are currently smoking. Other concurrent tobacco use is also acceptable.

You may qualify if:

  • An adult (18+)
  • Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).
  • Any type of cancer (except non-melanoma skin cancer)
  • Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation
  • Access to the Internet

You may not qualify if:

  • Not smoked 100 cigarettes in their lifetime
  • \< 18 years in age
  • Diagnosed with non-melanoma skin cancer
  • Not diagnosed with cancer
  • Does not anticipate receiving cancer treatments in the 3 months following enrollment
  • Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)
  • Not comfortable reading and responding to questions in English
  • No consistent access to the Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Cancer Center and affiliated sites

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

SmokingNeoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor of Public Health Sciences

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 12, 2022

Study Start

July 18, 2022

Primary Completion

February 13, 2024

Study Completion

February 13, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations