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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04844645
Other study ID # FJZLYX001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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