- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06307496
VIDEO'S voor stoppen met roken
Video-interventies voor afhankelijkheid van roken (VIDeOS) voor kankerpatiënten: een gerandomiseerde gecontroleerde 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- Medical University of South Carolina
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Videos
Participants will be sent links to smoking cessation videos to watch. |
Receive links to smoking cessation videos |
|
Actieve vergelijker: NCI Pamphlet
Participants will be sent links to NCI's "Clearing the Air" to read. |
Receive NCI's "Clearing the Air" booklet |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acceptability of Intervention Measure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Questions About Knowledge Related to Quitting Smoking That Were Answered Correctly
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00133913
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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