Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

Virtual Intervention for Lung Cancer (VILC)

2018. október 9. frissítette: University of California, San Francisco
Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma (LCS) and difficult patient-clinician communication may be an underlying factor in health disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows individuals to experience first person virtual visits with their clinicians, to improve patient-clinician communication, decrease LCS, and promote optimal self-management. The study hypotheses are that patients who receive the mHealth TLC will improve their ability to communicate effectively with their clinicians and will report decreased stigma related to their lung cancer diagnosis compared to the attention control group.

A tanulmány áttekintése

Állapot

Visszavont

Körülmények

Részletes leírás

This is a two arm experimental design PILOT test of the mHealth Tool for Lung Cancer patients (mHealthTLC) an intervention to improve patient-clinician communication, decrease lung cancer stigma, and decrease lung cancer symptom scores. Patients will be assigned to either the mHealth TLC group or the Attention Control Group (ACG). Interventions in both groups will be delivered online or by iPad in a research office in the clinician's building prior to each visit. Assessments will be done immediately after each visit in the same research room. Intervention and assessment pre-visit is expected to take less than one hour, the intervention is expected to take 30mins, and post assessment is expected to take 30 minutes. A follow-up assessment will be done at 3 months from enrollment.

mhealth TLC group will meet with a nurse just before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive, immersive 3-dimensional (3-D) intervention that allows individuals to experience virtual visits with their clinicians. The mHealth TLC provides engagement and experiential learning by delivering important information about symptom management and provides the opportunity to practice a new communication strategy in ever increasing complex situations with a virtual coach, receptionist, assistant, and clinician.During the mHealthTLC the patient will enter a virtual clinic office, travel through the different aspects of a typical clinic visit, and interact with office staff and clinicians that are represented by avatars. The avatars will be designed to reflect ethnic and cultural diversity. First person is the preferred format for health teaching because the patient is active as self and not represented as an avatar. The first person vantage point facilitates the immersion and immediacy of the experience. Key aspects of mHealthTLC include informational videos about lung cancer (i.e. etiology, diagnosis, treatment, symptoms) and LCS. Blame and self-blame will be addressed, information about the role of addiction, social/cultural factors, and tobacco industry influence on smoking behaviors will be highlighted. Information and training will be provided and patients will be able to experience practiced interaction in ever increasing complex situations with avatars (i.e., receptionist, medical assistant, and clinician). A "virtual coach" will accompany the patient through the virtual visit and will provide information and coaching (as needed). The advantages to adding a virtual coach or avatar include the availability of an always-live agent and the capability of customizing the coach to represent an ideal social model for a particular user or group of users.Flexibility exists in how to design not only how the coach will appear but also how the coach will sound - with an appropriate voice and engaging non-verbal communication). This approach contributes to cultural and ethnic sensitivity. As the patient attempts to communicate and receive information appropriate for a self-management plan, they will receive "points" for successful communication. A cumulative score and explanation will be given at the end of the virtual visit. During the visit the participant will identify specific topics and questions that they want to address during their visit with their real clinician; they will receive a printout of their priority questions that they can take into the visit with their real clinician. The research nurse will review the score, the priority questions, and the overall virtual experience. Virtual environments for learning are sufficiently promising that further investment and development of this type of research is warranted.

Attention control group (ACG)- Patients assigned to the ACG will meet with a nurse and receive the informational videos from the mHealth TLC on an iPad before 4 clinician visits with assessments after each clinician visit. An effort will be made to match the intervention condition on salience, credibility, and contact time.

Tanulmány típusa

Beavatkozó

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • California
      • San Francisco, California, Egyesült Államok, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

21 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • Inclusion criteria are >21 years old with a diagnosis of lung cancer (any type or stage), able to read and write English at 5th grade level, able to sign an IRB approved consent form, and expects to have 4 visits with the same clinician in the next 2 months.

Exclusion Criteria:

  • Unable to understand or tolerate the battery of questionnaires due to physical or mental health issues (i.e., dementia, active psychosis).

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Támogató gondoskodás
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: mHealth TLC
The mhealth TLC group will meet with a nurse before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive 3-dimensional intervention that allows individuals to experience virtual visits with their clinicians. Key aspects of mHealthTLC include informational videos about lung cancer and LCS. Blame and self-blame will be addressed, information about the role of addiction, social/cultural factors, and tobacco industry influence on smoking behaviors will be highlighted. Patients will experience practiced interaction in ever increasing complex situations with avatars (i.e., receptionist, medical assistant, and clinician). A "virtual coach" will accompany the patient through the virtual visit and will provide information and coaching (as needed).
Aktív összehasonlító: Attention Control
Attention control group (ACG) - Patients assigned to the ACG will meet with a nurse and receive only the informational videos on an iPad before 4 clinician visits with assessments after each clinician visit. An effort will be made to match the intervention condition on salience, credibility, and contact time.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Patient-clinician communication scores
Időkeret: 3 months
The Medical Communication Competence Scale (MCCS) measures patients' perceptions of their competence to effectively communicate. The Patients' Self-Competence Subscale of the MCCS has 16-items with a 5 point Likert-type scaling of 5 (important) to 1 (unimportant). Higher scores indicate greater perceived self-competence. The Quality of Physician-Patient Interaction (QQPPI) measures distinct domains that establish a high quality clinician-provider interaction (i.e.,information exchange, patient involvement, and sharing in the decision making process). Fourteen items are summed to yield a total score; higher scores indicate increased quality of communication as perceived by the patient.
3 months
Perceived lung cancer stigma
Időkeret: 3 months
The Cataldo Lung Cancer Stigma Scale (CLCSS) will be used to assess stigma. The CLCSS is a 31 item measure with each item rated on a 4-point Likert-type scale (strongly disagree to strongly agree). Higher values indicate higher levels of LCS.The CLCSS was found to be a reliable and valid measure with a diverse sample of people with lung cancer. Construct validity was supported by expected relationships with related constructs: self-esteem, depression, social support, and social conflict. The total scale Cronbach alpha coefficient was 0.96, the Cronbach alphas for the four subscales were: stigma/shame, 0.96; social isolation, 0.95; discrimination, 0.92; and smoking 0.76.
3 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Lung Cancer symptoms
Időkeret: 3 months
Lung Cancer Symptoms - Lung Cancer Symptom Scale (LCSS) measures the physical and functional dimensions of persons with lung cancer. The scale has 9 items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items related to total symptoms. The item scale is 0 (best) and 100 (worst). An average of all 9 items is the total score.
3 months
Depression
Időkeret: 3 months
Depression - Center for Epidemiologic Studies-Depression (CES-D) is a 20-item scale that is widely used for self-ratings of depression in clinical populations, including people with cancer.
3 months
Quality of Life (QOL)
Időkeret: 3 months
QOL - The QOL Inventory is a 33-item instrument that measures four dimensions of QOL in cancer patients (i.e., symptoms, social concerns, psychological well-being, and physical well being).
3 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Janine Cataldo, PhD, UCSF Department of Physiological Nursing

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2016. augusztus 1.

Elsődleges befejezés (Várható)

2017. augusztus 1.

A tanulmány befejezése (Várható)

2017. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2012. szeptember 5.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2012. szeptember 10.

Első közzététel (Becslés)

2012. szeptember 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. október 11.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2018. október 9.

Utolsó ellenőrzés

2018. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 12-09184
  • (pC ID): 237290 (Egyéb támogatási/finanszírozási szám: TRDRP 21XT-0063)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel