- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04049968
Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental group
Patients in the experimental group were individually assessed by a 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.
|
Traditional routine health care and instruction was applied to patients with oral cancer.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of the subjects' quality of life
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of the subjects' response to health IT
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lee-Chen Chen, Far Eastern Memorial Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 105110-E
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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