Cancer PainNCT04844645
Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain
A study testing mini program and conventional pharmaceutical care in people with Cancer Pain, run by Fujian Cancer Hospital.
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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Pain
- What is being tested?
- mini program and conventional pharmaceutical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Cancer Pain Patients With or Without Mini Program
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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- mini program, conventional pharmaceutical care
- Keywords
- mini program, self management, cancer pain
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini programOther
Also called "yao nin you wo "
To design, construct, and test the mini program in patients managing cancer pain
conventional pharmaceutical careOther
conventional pharmaceutical care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Change from baseline at four weeks after discharge
Secondary outcomes (3)
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.
Measured: Change from baseline at four weeks after discharge
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.
Measured: Up to four weeks after discharge
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).
Measured: Change from baseline at four weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experiment involved two groups: a mini program trial group and a control group.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844645
- Sponsor's protocol ID
- FJZLYX001
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cancer Pain Patients With or Without Mini Program
- ClinicalTrials.gov ID
- NCT04844645
- Acronym / sponsor ID
- FJZLYX001
- Conditions
- Cancer Pain
- Keywords
- mini program, self management, cancer pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experiment involved two groups: a mini program trial group and a control group.
| Arm | Type | Receives |
|---|---|---|
| a mini program trial group | Experimental | Other: mini programPharmacists 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. |
| a control group | Sham comparator | Other: conventional pharmaceutical careThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mini programAlso: "yao nin you wo "To design, construct, and test the mini program in patients managing cancer pain | Other | a mini program trial group |
| conventional pharmaceutical careconventional pharmaceutical care | Other | a control group |
Primary outcome
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."
3 secondary outcomes
Change in medication adherence
Time frame: Change from baseline at four weeks after discharge
Incidence of adverse events
Time frame: Up to four weeks after discharge
Change in quality of life
Time frame: Change from baseline at four weeks after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing mini program and conventional pharmaceutical care in people with Cancer Pain, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QiuLing Zhao (0591-83660063 ext. 5305, qlzhao8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: Change from baseline at four weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.