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

JRCT ID: jRCT1030210638

Registered date:03/03/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Neoplasms of Breast, Ovarian, Uterine Cervical, Uterine, Colon, or Thyroid
• Date of first enrollment: 07/06/2022
• Target sample size: 210
• Study type: Interventional

Intervention(s)

An online support program was designed to improve and maintain quality of life in female cancer patients by empowering them to manage their own health behavior. The program consisted of three kinds of applications to help patients: a) check their own understanding of cancer diagnosis and treatment; b) facilitate health monitoring, and c) address mental health issues. The program will be provided to the patients after having received a diagnosis and explanation of the disease and its treatment from their physician.
The patients assigned to the experimental group will use the application to carry out health monitoring, check their understanding of their cancer diagnosis and treatment, and to address mental health issues. Meanwhile the patients who are assigned to a control group will use the application only for health monitoring.

Outcome(s)

• Primary Outcome: 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

1) The total scores measured using the QLI-J at baseline, at 1 month, and at 3 months.
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.
3) Level of satisfaction with health care needs and evaluation of the online support program measured using ordinal scales.
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.
5) Descriptions written to help participants improve their mental health improve through use of the application.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Mizuno Michiyo
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Pfizer Health Research Foundation