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

NCT04844645 | Unknown

• 1 other identifier: FJZLYX001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer Pain

Keywords

mini program, self management, cancer pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in medication adherence

  Change from baseline at four weeks after discharge

• Incidence of adverse events

  Up to four weeks after discharge

• Change in quality of life

  Change from baseline at four weeks after discharge

Study Arms (2)

a mini program trial group

EXPERIMENTAL

Pharmacists conducted a standardized education session to teach the participants how to operate the mobile phone, use mini program, assess pain. The participants in the trial group were asked to complete initial and final pain assessment questionnaires and Medication compliance on the mobile phones provided to them. Participants were encouraged to use mini program as much as possible to record their pain status.

Other: mini program

a control group

SHAM COMPARATOR

The control group received conventional pharmaceutical care. Initial and final pain and Medication compliance data were collected. Before the patient was discharged from the hospital, the clinical pharmacist conducted detailed medication education (including medication methods, prevention and treatment of adverse reactions, and precautions) and asked the patient to attempt to maintain a paper version of the pain diary.

Other: conventional pharmaceutical care

Interventions

mini program OTHER

To design, construct, and test the mini program in patients managing cancer pain

Also known as: "yao nin you wo "

a mini program trial group

conventional pharmaceutical care OTHER

conventional pharmaceutical care

a control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

QiuLing Zhao

CONTACT

0591-83660063; qlzhao8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The experiment involved two groups: a mini program trial group and a control group.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: May 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 1, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share