Cancer PainPhase 3NCT06663956
A Randomized Controlled Trial of a Web-based Platform for Cancer Pain Management
A Phase 3 study testing a patient self-reporting applet in people with Cancer Pain, run by West China Hospital at 1 site in China.
Trial summary
Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Pain
- What is being tested?
- a patient self-reporting applet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 10 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 with tumors that are confirmed by pathological findings.
- Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
- Have a life expectancy of more than 6 months.
- Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.
Who cannot join
- Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
- Moderately severe cognitive impairment/cognitive impairment.
- Have schizophrenia or other psychiatric illness.
- Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
- Being pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan Universit
Chengdu, Sichuan, 610041
XingChen Peng, Ph.D, +8618980606753, pxx2014@163.com
About this study
Official title: A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management
Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.
- Conditions
- Cancer Pain
- Being tested
- a patient self-reporting applet
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a patient self-reporting appletBehavioural
We propose to develop a patient self-reporting applet that is easy to use and simple to operate. The program is embedded with questionnaires related to cancer pain and quality of life assessment, so that patients can fill out the questionnaires to report their symptoms and changes in their conditions to primary care doctors in a timely manner. At the same time, the background of the program will monitor the patient's indicators in real time. When the patient's pain reaches moderate-to-severe level, or when the patient experiences side effects of drugs, or when the patient's adherence to medication is poor, the primary care doctor can immediately receive relevant alerts through the app, so as to intervene in the patient's cancer pain treatment. When the patient has an "alarm value", primary care doctors can provide feedback to doctors in higher-level hospitals and implement comprehensive and standardized treatment for cancer pain patients.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The conventional treatment paradigm is in the current paradigm of standard antitumor cancer pain treatment and follow-up with no warning and no patient feedback. |
| Experimental group | Experimental | We propose to develop a patient self-reporting applet that is easy to use and simple to operate. The program is embedded with questionnaires related to cancer pain and quality of life assessment, so that patients can fill out the questionnaires to report their symptoms and changes in their conditions to primary care doctors in a timely manner. At the same time, the background of the program will monitor the patient's indicators in real time. When the patient's pain reaches moderate-to-severe level, or when the patient experiences side effects of drugs, or when the patient's adherence to medication is poor, the primary care doctor can immediately receive relevant alerts through the app, so as to intervene in the patient's cancer pain treatment. When the patient has an "alarm value", primary care doctors can provide feedback to doctors in higher-level hospitals and implement comprehensive and standardized treatment for cancer pain patients. Receives: Behavioral: a patient self-reporting applet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's average pain level (derived from the Brief Pain Scale)
The Brief Pain Inventory (BPI) is a validated tool for assessing pain intensity and impact on daily life.
The BPI consists of two parts: the first part assesses the intensity of pain using a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst pain; the second part assesses the impact of pain on various aspects of the patient's life (e.g., mood, work, sleep, and social activities).
The BPI is simple and easy to use, and can help healthcare professionals to quickly obtain quantitative information about pain and monitor the effectiveness of pain management.
Measured: From patient enrollment to 3 months, during which time the applet was used once a week
Secondary outcomes (3)
Mood and physical state of the patient (derived from the EQ-5D scale)
The EQ-5D is a brief scale used to assess an individual's health status and quality of life.The EQ-5D provides a standardized assessment of a patient's health-related quality of life. The scale consists of two parts: the first part is a self-assessment of five dimensions, including mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression, each of which is scored on a scale ranging from "no problem," "mild problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," "moderate problem," and "moderate problem, "Moderate Problems, Severe Problems, and Extreme Problems. The second part is a visual analog scale (VAS) that assesses general health on a scale from 0 (very poor health) to 100 (optimal health).
Measured: From patient enrollment to 3 months, during which time the applet was used twice a week
Burden situation of family members (derived from the Family Support Scale)
The Family Support Scale (FSS) is an instrument used to assess the level of support an individual receives in their home environment. The Family Support Scale usually contains items along multiple dimensions, such as emotional support (e.g., care and understanding), material support (e.g., material help), informational support (e.g., advice and guidance), and other relevant family interaction factors. Respondents rate their feelings and experiences of family support, usually on a Likert scale, e.g., from "completely disagree" to "completely agree."
Measured: From patient enrollment to 3 months, during which time the applet was used twice a week
Patient quality of life (derived from the QLQ-C30 core quality of life questionnaire)
The C30 scale (EORTC QLQ-C30) is an instrument developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess the quality of life of cancer patients. The scale consists of 30 entries covering the two main dimensions of functioning (e.g., physical, emotional, and social functioning) and symptoms (e.g., pain, fatigue), as well as general health. Patients are scored based on how they have felt over the past week, with scores typically ranging from 0 to 100. Higher scores indicate better quality of life, higher functional status, and less severe symptoms, while lower scores indicate poorer quality of life, limited functioning, and more severe symptoms.The C30 Scale is widely used in cancer research and clinical practice to monitor patients' health status and treatment outcomes.
Measured: From patient enrollment to 3 months, during which time the applet was used twice a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start10 Nov 2024
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (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.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663956
- Sponsor's protocol ID
- 2024-1948
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2024
- Last updated
- 30 Apr 2026
- Results posted
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management
- ClinicalTrials.gov ID
- NCT06663956
- Acronym / sponsor ID
- 2024-1948
- Conditions
- Cancer Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 29 Oct 2024 (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.
Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The conventional treatment paradigm is in the current paradigm of standard antitumor cancer pain treatment and follow-up with no warning and no patient feedback. |
| Experimental group | Experimental | Behavioral: a patient self-reporting appletWe propose to develop a patient self-reporting applet that is easy to use and simple to operate. The program is embedded with questionnaires related to cancer pain and quality of life assessment, so that patients can fill out the questionnaires to report their symptoms and changes in their conditions to primary care doctors in a timely manner. At the same time, the background of the program will monitor the patient's indicators in real time. When the patient's pain reaches moderate-to-severe level, or when the patient experiences side effects of drugs, or when the patient's adherence to medication is poor, the primary care doctor can immediately receive relevant alerts through the app, so as to intervene in the patient's cancer pain treatment. When the patient has an "alarm value", primary care doctors can provide feedback to doctors in higher-level hospitals and implement comprehensive and standardized treatment for cancer pain patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with tumors that are confirmed by pathological findings.
- Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
- Have a life expectancy of more than 6 months.
- Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.
Key exclusion criteria (5 listed)
- Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
- Moderately severe cognitive impairment/cognitive impairment.
- Have schizophrenia or other psychiatric illness.
- Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
- Being pregnant.
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 |
|---|---|---|
| a patient self-reporting appletWe propose to develop a patient self-reporting applet that is easy to use and simple to operate. The program is embedded with questionnaires related to cancer pain and quality of life assessment, so that patients can fill out the questionnaires to report their symptoms and changes in their conditions to primary care doctors in a timely manner. At the same time, the background of the program will monitor the patient's indicators in real time. When the patient's pain reaches moderate-to-severe level, or when the patient experiences side effects of drugs, or when the patient's adherence to medication is poor, the primary care doctor can immediately receive relevant alerts through the app, so as to intervene in the patient's cancer pain treatment. When the patient has an "alarm value", primary care doctors can provide feedback to doctors in higher-level hospitals and implement comprehensive and standardized treatment for cancer pain patients. | Behavioural | Experimental group |
Primary outcome
Patient's average pain level (derived from the Brief Pain Scale)
Time frame: From patient enrollment to 3 months, during which time the applet was used once a week
The Brief Pain Inventory (BPI) is a validated tool for assessing pain intensity and impact on daily life. The BPI consists of two parts: the first part assesses the intensity of pain using a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst pain; the second part assesses the impact of pain on various aspects of the patient's life (e.g., mood, work, sleep, and social activities). The BPI is simple and easy to use, and can help healthcare professionals to quickly obtain quantitative information about pain and monitor the effectiveness of pain management.
3 secondary outcomes
Mood and physical state of the patient (derived from the EQ-5D scale)
Time frame: From patient enrollment to 3 months, during which time the applet was used twice a week
Burden situation of family members (derived from the Family Support Scale)
Time frame: From patient enrollment to 3 months, during which time the applet was used twice a week
Patient quality of life (derived from the QLQ-C30 core quality of life questionnaire)
Time frame: From patient enrollment to 3 months, during which time the applet was used twice a week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing a patient self-reporting applet in people with Cancer Pain, run by West China Hospital at 1 site in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's average pain level (derived from the Brief Pain Scale) (time frame: From patient enrollment to 3 months, during which time the applet was used once a week). 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 30 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.