NCT06484179

Brief Summary

The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
13mo left

Started Aug 2024

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Aug 2024Jul 2027

First Submitted

Initial submission to the registry

June 18, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 28, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

June 18, 2024

Last Update Submit

November 21, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Recruitment

    Number of participants who consent to participate in the study

    Baseline

  • Retention- Completion of 2-week follow-up

    Number of participants who complete the 2-week follow-up assessment

    2 weeks post-randomization

  • Retention- Completion of 1 month follow-up

    Number of participants who complete the 1 month follow-up assessment

    1 month post-randomization

  • Adherence- 2 weeks post-randomization

    Number of participants who read the booklet 2 weeks post-randomization

    2 weeks post-randomization

  • Adherence- 1 month post-randomization

    Number of participants who read the booklet 1 month post-randomization

    1 month post-randomization

  • Acceptability

    Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire. Values between 8 and 32 with higher scores indicating higher satisfaction.

    2 weeks post-randomization, 1 month post-randomization

Secondary Outcomes (4)

  • Motivation to quit smoking

    Baseline, 2 weeks post-randomization, 1 month post-randomization

  • Treatment Engagement defined by the number of participants who enroll with the state tobacco quitline

    2 weeks post-randomization, 1 month post-randomization

  • Smoking Status

    2 weeks post-randomization, 1 month post-randomization]

  • Smoking Status

    2 weeks post-randomization, 1 month post-randomization

Study Arms (2)

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Usual Care + Targeted Self-Help Intervention

EXPERIMENTAL
Behavioral: Targeted Self-Help

Interventions

In addition to usual care participants will receive a self-help booklet specific for their cancer type. There are five booklets available, written at a 5-6th grade reading level and targeted by cancer type, that explain the connection between smoking and each cancer type, describe the benefits of quitting smoking after cancer, and address some of the barriers cancer patients face to quit smoking when fighting cancer. Each booklet also includes four testimonials inspired from conversations with patients.

Usual Care + Targeted Self-Help Intervention
Usual CareBEHAVIORAL

Participants will receive the standard care typically offered for smoking cessation.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Individuals who smoke and recently (i.e., within 6 months) received a diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer (n = 20 per cancer type). (Investigators will consider smokers individuals who report having smoked ≥1 cigarette in the past 30 days.)
  • Able to read/write English;
  • Able to give informed consent;
  • Not currently enrolled in a smoking cessation program;
  • Age ≥18 years old.

You may not qualify if:

  • Male patients diagnosed with breast cancer will be excluded as lifetime risk for breast cancer in men is far below 1%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ursula Martinez, PhD

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized to (1) Usual Care or (2) Usual Care + targeted self-help intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 3, 2024

Study Start

August 28, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations