Effects and Functioning of an Online Support Program to Facilitate Female Cancer Patients Managing their Health and Illness

Not Applicable

• Conditions: eoplasms of Breast, Ovarian, Uterine Cervical, Uterine, Colon, or Thyroid; D001943, D010051, D002583, D014594, D003110 ,D013964

• Registration Number: JPRN-jRCT1030210638
• Lead Sponsor: Mizuno Michiyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

Patients will be included who meet the following criteria:
1) Patients with cancer diagnosis who have been explained about medical condition and the treatment courses by their physician
2) Patients who receive treatment for cancer for the first time in the National Cancer Center Hospital East
3) Patients who are waiting to be treated in hospital or in an outpatient setting
4) Patients who are from 18 to 75 years old at the time of obtaining informed consent
5) Patients who can go through the online support-program using tablet computers, personal computers, or smartphones at an outpatient setting or in their homes
6) Patients who are required to receive treatment at the departments of breast surgery, medical oncology, gynecology, gastrointestinal oncology, or head and neck medical oncology

Exclusion Criteria

Patients will be excluded when the
1) physician in charge or a nurse in charge determined that the patient is disqualified because there is a high possibility of having a detrimental health effect when the patient participates in the online support program;
2) physician in charge or a nurse in charge determined that the patient is disqualified because she is mentally unstable and has difficulty participating in the online support program
3) physician in charge or a nurse in charge has known that the patient needs to receive hospital treatment for at least one month or longer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total score measured by using the Japanese version of the Ferrans and Powers Quality of Life Index (QLI-J) at 6 months after measuring baseline score.

Secondary Outcome Measures

Name	Time	Method
1) The total scores measured using the QLI-J at baseline, at 1 month, and at 3 months.<br>2) Four kinds of subscales' scores (health/functioning, social/economic, psychological/spiritual, family) measured using the QLI-J; two kinds of subscales' scores (symptoms, symptom related interference) measured using the M.D. Anderson Symptom Inventory; and two kinds of subscales' scores (anxiety, depression) measured using the Hospital Anxiety and Depression Scale at baseline, at 1 month, at 3 months, and at 6 months.<br>3) Level of satisfaction with health care needs and evaluation of the online support program measured using ordinal scales.<br>4) Nominal variables will be drawn from participants' responses to questions about their own medical conditions,the treatment course, and issues related to the disease and treatment. <br>5) Descriptions written to help participants improve their mental health improve through use of the application.