NCT06307496

Brief Summary

The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

March 5, 2024

Last Update Submit

September 10, 2025

Conditions

Keywords

Videos

Outcome Measures

Primary Outcomes (3)

  • Acceptability

    Acceptability will be measured using the Acceptability of Intervention measure, which contains four items with answer options on a scale from 1-5, with higher scores indicating higher acceptability. We will consider the intervention "acceptable" if an average score of 4 or higher is obtained.

    1 week post-randomization

  • Feasibility

    Feasibility will be measured using the Feasibility of Intervention measure, which contains four items with answer options on a scale from 1-5, with higher scores indicating higher feasibility. We will consider the intervention "feasible" if an average score of 4 or higher is obtained.

    1 week post-randomization

  • Retention Rates

    We will determine if there are differences in retention rates between intervention groups.

    1 week, 1 month, and 3 months post-randomization

Secondary Outcomes (2)

  • Changes in knowledge about quitting smoking

    Baseline, 1 week, 1 month, and 3 months post-randomization

  • Changes in smoking behaviors

    1 week, 1 month, and 3 months post-randomization

Study Arms (2)

Videos

EXPERIMENTAL

Participants will be sent links to smoking cessation videos to watch.

Other: Smoking cessation intervention

NCI Pamphlet

ACTIVE COMPARATOR

Participants will be sent links to NCI's "Clearing the Air" to read.

Other: Informational intervention

Interventions

Receive links to smoking cessation videos

Videos

Receive NCI's "Clearing the Air" booklet

NCI Pamphlet

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Diagnosed with cancer (any type)
  • Receiving care at Medical University of South Carolina
  • Reads and understands English language
  • Currently smoking cigarettes (any amount)

You may not qualify if:

  • \- Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral-Fellow

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

September 24, 2024

Primary Completion

September 10, 2025

Study Completion

September 10, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations