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Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.

7. august 2019 opdateret af: Far Eastern Memorial Hospital

This study aimed to explore using an APP in post oral cancer surgery to affect patients' needs and quality of life.

Methods Quasi-experimental Research Design used purposeful sampling from January 1 to December 31 of the Far Eastern Memorial Hospital oral maxillofacial surgery ward and the otolaryngology ward requirement met post-treatment oral cancer patients who agreed to participate. Self-administered structured questionnaires, including basic personal information, cancer needs table short version (CNQ-SF), head and neck cancer quality of life scale (EORTC QLQ-H&N35), were used to collect information. Results were statistically analyzed to understand the distribution of variables and their relationships.

Scientific or Clinical Implication of the Expected Results Using an APP intervention in post-operative patients with oral cancer may be the better way to promote health and enhance one's quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The malignant tumor has been consecutively ranked as number one of the top ten causes of death over the past 33 years, and the incidence of an increase in oral cancer year by year. The average age of death was 55-57. With this average age compared to other cancer patients under 10 years of early life, it's necessary to care about the burden of disease from oral cancer. The main treatment of oral cancer is surgery and a combination of radiotherapy and chemotherapy. Patients often got severe treatment complications with varying degrees of physical functions and uncertainty due to poor cognition or less clarification in a complex course of treatment that affects medical decisions in the illness process. Both domestic and foreign research show that the majority of oral cancer patients expressed the need for and attention to health information. "Treatment information" was the most needed and important. When information needs are met, it can effectively reduce the anxiety and unease of unknown events. Relevant domestic and foreign research do not provide accessibility and convenience of health education for post-operative patients with oral cancer.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

48 år til 66 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients were diagnosed with oral cancer and were the first-time receiving oral cancer surgery within 1 week.
  • Conscious and able o communicate
  • Patients agreed to participate in this study and had a smart phone.

Exclusion Criteria:

  • Patients without oral cancer
  • Patients with oral cancer but had received oral cancer surgery before 1 week or more.
  • Unconscious or unable to answer questions from questionnaire or APP
  • Patients with cognitive impairment, dementia o intellectual disability.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
Patients in the experimental group were individually assessed by a mobile health application (APP).
Enhed: Mobile health application (APP)
The mobile health application (APP) was applied to patients with oral cancer.
Aktiv komparator: Control group
Patients in the control group were individually assessed by a traditional routine health care and instruction.
Andet: Routine health care and instruction
Traditional routine health care and instruction was applied to patients with oral cancer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of the subjects' quality of life
Tidsramme: 3 month
The Quality of Life scale (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Module [EORTC QLQ-C30] and Head and Neck Module [QLQ-H&N35], or EORTC QLQ-H&N35) was used to represent patients' satisfaction with quality of life. The EORTC QLQ-H&N35 is a 30-item self-administered global health and quality of life questionnaire with 5 scales, including physical, role, cognitive, emotional and social functioning. In addition, the measuring items included the pain, swallowing, speech, taste/smell, eating, dry mouth, coughing, opening mouth and social contact and sexuality.
3 month
Changes of the subjects' physiological needs
Tidsramme: 3 month
Care Needs Scale (the short-form Cancer Needs Questionnaire, CNQ-SF) was used to measure baseline postoperative care needs, with score 0 meaning no care need and score 100 meaning highest care need. CNQ-SF is a 32-item self-administered questionnaire to evaluate five domains of patient needs, including psychological, health information, physical and daily living, patient care and support, and interpersonal communication needs.
3 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of the subjects' response to health IT
Tidsramme: 3 month
Science and Technology Acceptance Model scale was applied to evaluate patients' response to health IT. The scale measures subjects' intention, perceived usefulness, and perceived ease of use. Effectiveness is determined by a panel of experts, including nursing experts, nursing information experts and medical information experts.
3 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Far Eastern Memorial Hospital

Efterforskere

  • Ledende efterforsker: Lee-Chen Chen, Far Eastern Memorial Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

31. december 2017

Studieafslutning (Faktiske)

31. december 2017

Datoer for studieregistrering

Først indsendt

4. august 2019

Først indsendt, der opfyldte QC-kriterier

7. august 2019

Først opslået (Faktiske)

8. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2019

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 105110-E

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The data is currently under analysis.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Mundkræft

Kliniske forsøg med Mobile health application (APP)

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Narkotikainterventioner

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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