- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06307496
VIDEOER for røykeslutt
Videointervensjoner for avhengighet av røyking (VIDeOS) for kreftpasienter: En randomisert kontrollert 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability of Intervention Measure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Questions About Knowledge Related to Quitting Smoking That Were Answered Correctly
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00133913
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