Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain

Cancer Pain Clinical Trial

Official title:

Comparison of Cancer Pain Patients With or Without Mini Program

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04844645
• Other study ID #: FJZLYX001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2021
• Source: Fujian Cancer Hospital
• Contact: QiuLing Zhao
• Phone: 0591-83660063
• Email: qlzhao8[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the existing medical system and insufficient medical resources in China, we developed a mini program. a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country . our study want to develop and test the mini program for pain management among Chinese cancer patients in or discharged from hospital treatment.

Description:

Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.

To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older;

• Be able to read Chinese and use a mobile phone;

• Histologically or cytologically confirmed solid tumor;

• Diagnosed chronic cancer pain

• Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form.

Exclusion Criteria:

• Illiterate person;

• Incompetence;

• Inability to complete the pain assessment;

• Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study;

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• mini program
To design, construct, and test the mini program in patients managing cancer pain
• conventional pharmaceutical care
conventional pharmaceutical care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score	Comparison of pain score of cancer pain patients with or without mini program. Pain score will be assessed by using numeric rating scale (NRS). An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."	Change from baseline at four weeks after discharge
Secondary	Change in medication adherence	The investigators will measure the change in medication adherence via Morisky Scale. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.	Change from baseline at four weeks after discharge
Secondary	Incidence of adverse events	Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number of subjects who experienced an adverse event in this study is presented.	Up to four weeks after discharge
Secondary	Change in quality of life	Comparison of quality of life of cancer pain patients with or without mini program. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D).	Change from baseline at four weeks after discharge