Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer
RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco history, and quality of life related to cancer in patients with newly diagnosed head and neck cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- To pilot test a questionnaire measuring the collection of the following data from patients with newly diagnosed head and neck cancer: head and neck cancer-related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life.
- To identify questions that may be unclear or difficult for patients to understand.
- To determine the time required for each patient to complete the questionnaire and assess the feasibility and burden to the patient.
- To determine the baseline incidence of symptoms and psychosocial issues in these patients.
OUTLINE: Patients complete a timed questionnaire comprising questions of head and neck symptoms, demographic information, pain control, symptom control, mood, smoking and drinking history, and anxiety and depression under the supervision of the investigator.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Diagnosis of head or neck carcinoma
- Newly diagnosed disease
- Able to speak English
- Able to give informed consent
Exclusion Criteria:
Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life
Tidsramme: at time of patient exam
|
collection of the following data from newly diagnosed HNC patients:
Questions will be identified that may be unclear or difficult for patients to understand for future revision. |
at time of patient exam
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time required for questionnaire completion by each patient
Tidsramme: at time of patient exam
|
The investigator will verbally explain the purpose of the study using a script (provided with this packet) and obtain verbal consent from the patient. The questionnaire will be handed to the patient with instructions on how to complete it. The investigator will remain available in the room to address any concerns regarding the questionnaire and to time how long the patient takes to complete the survey. When the patient has completed the questionnaire, the investigator will review it for completeness with the patient. The patient's participation in the study ends at this time. |
at time of patient exam
|
|
Feasibility and patient burden assessment
Tidsramme: at time of patient exam
|
at time of patient exam
|
|
|
Baseline incidence of symptoms and psychosocial issues
Tidsramme: at time of patient exam
|
at time of patient exam
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VICC SUPP 0723
- VU-VICC-SUPP-0723
- VU-VICC-070493
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