- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02957565
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit: A Randomized Controlled Trial
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Study Groups:
After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups.
Each group will watch 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and will discuss the same content, but setting of each video will be different.
After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete.
After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires.
Length of Study:
It should take about 38 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.
Other Information:
You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions.
This is an investigational study.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow ups) seen in the Supportive Care Clinic.
- Age >/= 18 years old
- English speaking
- Patients with normal cognitive status (Memorial Delirium Assessment Scale (MDAS) </=6/30) who are able to understand the nature and purpose of the study and have the ability to complete the consent process.
Exclusion Criteria:
1) Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Video 1: No EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Andre navne:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Andre navne:
|
|
Eksperimentel: Video 1: No EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Andre navne:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Andre navne:
|
|
Eksperimentel: Video 2: With EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Andre navne:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Andre navne:
|
|
Eksperimentel: Video 2: With EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Andre navne:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant's Rating of Physician's Compassion
Tidsramme: 1 day
|
Participant's rating of physician's compassion assessed by using a 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate distant, sensitive insensitive, caring-uncaring.
The sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant's Rating of Physician Communication Skills
Tidsramme: 1 day
|
Participant's rating of physician communication skills assessed by using a 14-item tool consisting of 1 to 4 numerical rating scales assessing communication skills.
The sum of these 14 scales gives a final score representing physician's communication skills with a 14 to 70 scale.
|
1 day
|
|
Participant's Rating of Physician's Professionalism
Tidsramme: 1 day
|
Participant's rating of physician's professionalism assessed by using a 4-item tool assessing politeness, listening, explaining the condition and treatment to the participant and participant's involvement in treatment decisions.
Participant rates from poor to very good.
|
1 day
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ali Haider, MBBS, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-0494
- NCI-2017-00621 (Registry Identifier: NCI CTRP)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Avanceret kræft
-
National Cancer Institute, NaplesRekrutteringLocally Advanced Rectal Cancer (LARC)Italien
-
Cai ZerongAfsluttet
-
Chinese PLA General HospitalIkke rekrutterer endnu
-
Beijing Bio-Targeting Therapeutics Technology Co...Trukket tilbage
-
Gruppo Oncologico Italiano di Ricerca ClinicaGlaxoSmithKlineIkke rekrutterer endnu
-
The First Affiliated Hospital of Xiamen UniversityIkke rekrutterer endnuLocally Advanced Breast Cancer (LABC)
-
Novartis PharmaceuticalsAfsluttetcMET Dysegulation Advanced Solid TumorsØstrig, Danmark, Sverige, Det Forenede Kongerige, Spanien, Tyskland, Holland, Forenede Stater
-
Providence Health & ServicesMidlertidigt ikke tilgængeligKRAS G12V Mutant Advanced Epithelial Cancers
-
Samsung Medical CenterAfsluttetHER2-positiv Refractory Advanced CancerKorea, Republikken
-
Shanghai Qilu Pharmaceutical Research and Development...Ikke rekrutterer endnuMSI-H eller dMMR Advanced Solid Tumors