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

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ClinicalTrials.gov Identifier: NCT04844645
Recruitment Status : Not yet recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Pain Other: mini program Other: conventional pharmaceutical care Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The experiment involved two groups: a mini program trial group and a control group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Cancer Pain Patients With or Without Mini Program
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: a mini program trial group
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
To design, construct, and test the mini program in patients managing cancer pain
Other Name: "yao nin you wo "
Sham Comparator: a control group
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
conventional pharmaceutical care


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain score [ Time Frame: Change from baseline at four weeks after discharge ]
    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."


Secondary Outcome Measures :
  1. Change in medication adherence [ Time Frame: Change from baseline at four weeks after discharge ]
    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.

  2. Incidence of adverse events [ Time Frame: Up to four weeks after discharge ]
    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.

  3. Change in quality of life [ Time Frame: Change from baseline at four weeks after discharge ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844645


Contacts
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Contact: QiuLing Zhao 0591-83660063 ext 5305 qlzhao8@163.com

Sponsors and Collaborators
Fujian Cancer Hospital
More Information
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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT04844645    
Other Study ID Numbers: FJZLYX001
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fujian Cancer Hospital:
mini program, self management, cancer pain
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations