Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening
Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Test the feasibility and acceptability of the video-based intervention.
SECONDARY OBJECTIVES:
I. To describe incidence, degree, and duration of screen-related anxiety among individuals scheduled to undergo low-dose computed tomography (CT) scan (LDCT) for lung cancer screening (LCS).
II. To describe baseline patient characteristics and pre-screening anxiety levels.
III. To describe the preliminary outcomes on screen-related anxiety for patients both not in the intervention group and those in the intervention group.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
GROUP II: Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-Imaging Reporting and Data Systems [RADS] 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
After completion of LCS, patients are followed up at 1 week and then at 3 and 7 months.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Duarte, California, Forente stater, 91010
- City of Hope Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- This study will be conducted in people scheduled to undergo baseline LDCT as part of the City of Hope (COH) LCS program
- There are no restrictions related to performance status and life expectancy
- All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study
Exclusion Criteria:
- Patients who do not speak or read, because all intervention materials, including the video and written materials are in English
- Subjects, who in the opinion of the investigator, may not be able to comply with study procedures
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group I (standard of care)
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
|
Hjelpestudier
Hjelpestudier
Andre navn:
Andre navn:
|
|
Eksperimentell: Group II (video-based intervention)
Patients undergo a video-based intervention prior to undergoing LCS.
Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening.
Patients also receive an educational handbook.
Patients with positive scans (a Lung-RADS 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
|
Hjelpestudier
Hjelpestudier
Andre navn:
Undergo video-based intervention
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of patients who complete the intervention
Tidsramme: Baseline
|
Descriptive statistics will be presented on participation in all components of the intervention.
|
Baseline
|
|
Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
Tidsramme: Up to 7 months
|
This self-reported measure will be completed by subjects who received the intervention.
|
Up to 7 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
Tidsramme: Baseline to 7 months
|
The survey is used to diagnose anxiety and to distinguish it from depressive syndromes, with items rated on a 4-point scale (with 1 being "Almost Never" and 4 being "Almost Always").
|
Baseline to 7 months
|
|
Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire
Tidsramme: Up to 7 months
|
The SF-12 is designed for assessment of general health status and contains 7 items that measure physical functioning, role functioning, bodily pain, energy/fatigue, social functioning, mental health, emotional functioning, general health perceptions, and changes in health.
|
Up to 7 months
|
|
Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire
Tidsramme: Up to 7 months
|
This questionnaire is a non-validated adapted version of a validated two part tool used to assess the psychological impact to breast cancer screening using mammography.
|
Up to 7 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14169 (Annen identifikator: City of Hope Medical Center)
- NCI-2014-02220 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
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