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

NCT04049968 | Completed

• 1 other identifier: 105110-E
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Cancer

Keywords

Oral cancer、Post-Operation Needs、Quality of Life、APP

Outcome Measures

Primary Outcomes (2)

• Changes of the subjects' quality of life

  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

  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

Secondary Outcomes (1)

• Changes of the subjects' response to health IT

  3 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group were individually assessed by a mobile health application (APP).

Device: Mobile health application (APP)

Control group

ACTIVE COMPARATOR

Patients in the control group were individually assessed by a traditional routine health care and instruction.

Other: Routine health care and instruction

Interventions

Mobile health application (APP) DEVICE

The mobile health application (APP) was applied to patients with oral cancer.

Experimental group

Routine health care and instruction OTHER

Traditional routine health care and instruction was applied to patients with oral cancer.

Control group

Eligibility Criteria

• Age: 48 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Related Publications (1)

• Wang TF, Huang RC, Yang SC, Chou C, Chen LC. Evaluating the Effects of a Mobile Health App on Reducing Patient Care Needs and Improving Quality of Life After Oral Cancer Surgery: Quasiexperimental Study. JMIR Mhealth Uhealth. 2020 Jul 27;8(7):e18132. doi: 10.2196/18132.

  PMID: 32716303 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Lee-Chen Chen

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were divided into two two groups. Control group was assessed with traditional routine healthcare and instruction. Experimental group was assessed with a mobile health application.

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 8, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 8, 2019

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share