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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Duarte, California, Stati Uniti, 91010
- City of Hope Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
|
Studi accessori
Studi accessori
Altri nomi:
Altri nomi:
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Sperimentale: 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.
|
Studi accessori
Studi accessori
Altri nomi:
Undergo video-based intervention
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent of patients who complete the intervention
Lasso di tempo: Baseline
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Descriptive statistics will be presented on participation in all components of the intervention.
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Baseline
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Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
Lasso di tempo: Up to 7 months
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This self-reported measure will be completed by subjects who received the intervention.
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Up to 7 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
Lasso di tempo: Baseline to 7 months
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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").
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Baseline to 7 months
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Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire
Lasso di tempo: Up to 7 months
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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.
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Up to 7 months
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Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire
Lasso di tempo: Up to 7 months
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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.
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Up to 7 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14169 (Altro identificatore: City of Hope Medical Center)
- NCI-2014-02220 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
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