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

Primary Purpose

Cancer Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mini program
conventional pharmaceutical care
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Pain focused on measuring mini program, self management, cancer pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    a mini program trial group

    a control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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."

    Secondary Outcome Measures

    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.
    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.
    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).

    Full Information

    First Posted
    April 8, 2021
    Last Updated
    April 13, 2021
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04844645
    Brief Title
    Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain
    Official Title
    Comparison of Cancer Pain Patients With or Without Mini Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    May 30, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pain
    Keywords
    mini program, self management, cancer pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The experiment involved two groups: a mini program trial group and a control group.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    a mini program trial group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    a control group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    mini program
    Other Intervention Name(s)
    "yao nin you wo "
    Intervention Description
    To design, construct, and test the mini program in patients managing cancer pain
    Intervention Type
    Other
    Intervention Name(s)
    conventional pharmaceutical care
    Intervention Description
    conventional pharmaceutical care
    Primary Outcome Measure Information:
    Title
    Change in pain score
    Description
    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."
    Time Frame
    Change from baseline at four weeks after discharge
    Secondary Outcome Measure Information:
    Title
    Change in medication adherence
    Description
    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.
    Time Frame
    Change from baseline at four weeks after discharge
    Title
    Incidence of adverse events
    Description
    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.
    Time Frame
    Up to four weeks after discharge
    Title
    Change in quality of life
    Description
    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).
    Time Frame
    Change from baseline at four weeks after discharge

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    QiuLing Zhao
    Phone
    0591-83660063
    Ext
    5305
    Email
    qlzhao8@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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