- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06307496
VIDEOS för rökavvänjning
Videointerventioner för beroende av rökning (VIDeOS) för cancerpatienter: en randomiserad kontrollerad pilotstudie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A randomized controlled pilot study is being conducted to test the acceptability and feasibility of a smoking cessation intervention tailored for cancer patients that is delivered via video. Participants will be in a video intervention or control group that receives information about quitting smoking. Participants will complete surveys prior to randomization, and will complete additional surveys one week, one month, and three months post-randomization to provide their thoughts about the videos, information about changes to smoking behaviors, and knowledge about quitting smoking.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Videos
Participants will be sent links to smoking cessation videos to watch. |
Receive links to smoking cessation videos |
|
Aktiv komparator: NCI Pamphlet
Participants will be sent links to NCI's "Clearing the Air" to read. |
Receive NCI's "Clearing the Air" booklet |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptability of Intervention Measure
Tidsram: 1 week post-randomization
|
Acceptability will be measured using the measure titled the "Acceptability of Intervention Measure" (AIM), which contains four items with answer options on a scale from 1-5. 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 of Intervention Measure
Tidsram: 1 week post-randomization
|
Feasibility will be measured using the measure title the "Feasibility of Intervention Measure" (FIM), which contains four items with answer options on a scale from 1-5. Answer responses are summed and averaged. 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
|
|
Number of Participants Retained
Tidsram: 1 week, 1 month, and 3 months post-randomization
|
We will determine if there are differences in retention rates between intervention groups. |
1 week, 1 month, and 3 months post-randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Questions About Knowledge Related to Quitting Smoking That Were Answered Correctly
Tidsram: 1 week
|
Questions about the impact of quitting smoking were asked to determine if there were numeric differences in the number of participants who answered each question correctly between intervention and control groups at 1-week follow-ups. Questions were true or false questions generated by the primary investigator. We calculated the number of participants who answered each of the three questions correctly. |
1 week
|
|
Number of Participants Who Made Quit Attempts and Achieved Smoking Abstinence at 1-week, 1-month, and 3-month Follow-ups
Tidsram: 1 week, 1 month, and 3 months post-randomization
|
We calculated the number of 24-hour quit attempts made by participants in each group at the 1-week, 3-month, and 6-month follow-ups. We also calculated the number of participants who reported past 7-day point prevalence abstinence at 1-week, 1-month, and 3-month follow-ups. |
1 week, 1 month, and 3 months post-randomization
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00133913
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