Cancer PainNCT03439904
Individualized Pharmaceutical-care in Outpatients With Cancer Pain
A study testing Pharmaceutical care in people with Cancer Pain, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to 30 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older;
- Histologically confirmed solid tumor;
- Diagnosed chronic cancer pain;
- Opioid-tolerant patients;
- Overall survival is expected to be over 3 months;
- Karnofsky performance score≥50;
- Willing and able to comply with the protocol
Who cannot join
- Patients aged 18 years or older;
- Histologically confirmed solid tumor;
- Diagnosed chronic cancer pain;
- Opioid-tolerant patients;
- Overall survival is expected to be over 3 months;
- Karnofsky performance score≥50;
- Willing and able to comply with the protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ping Huang, Doctor
About this study
Official title: Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients
Read the detailed description
This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.
- Conditions
- Cancer Pain
- Being tested
- Pharmaceutical care
- Keywords
- pharmaceutical care, adherence
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
| Study group | Role | What they receive |
|---|---|---|
| pharmaceutical care intervention group | Experimental | Patients will receive individualized pharmaceutical care in addition to usual medical care Receives: Other: Pharmaceutical care |
| control group | No intervention | Patients will receive usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence
The investigators will measure the change in medication adherence via Morisky Scale from baseline to 1 months. 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 1 month
Secondary outcomes (4)
Change in pain score
Comparison of pain score of cancer pain patients with or without pharmaceutical care. Pain score will be assessed 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 pain score at 1 month
Change in quality of life
Comparison of quality of life of cancer pain patients with or without pharmaceutical care. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D). It is a questionnaire to measure quality of life. It contains 5 domains: Mobility; Self-care; Usual activity; Pain; Anxiety/depression. It also contains a visual analogue scale. Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state)
Measured: Change from baseline quality of life at 1 month
Change in patients' knowledge of cancer pain and analgesics
Comparison of knowledge of cancer pain and analgesics for cancer pain patients with or without pharmaceutical care. Knowledge of pain treatment and analgesics will be assessed using investigator designed questionnaire. This questionnaire consists of 16 items assessing patients' knowledge about cancer pain, treatment of cancer pain and medications for cancer pain. The total score ranges from 0 to 16 with higher score indicating better knowledge.
Measured: Change from baseline knowledge at 1 month
Incidence of adverse events [safety and tolerability]
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 and percentage of subjects who experienced an adverse event in this study is presented.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start30 Jun 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Huang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439904
- Sponsor's protocol ID
- ECCOPG-003
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding H, Song Y, Wu N, Zheng X, Wei Q, Sun Y, Xie R, Zhai Q, Xu S, Qi Y, Wang Y, Li H, Yang L, Fan Q, Zhao Q, Chen J, Shi J, Duan C, Du Q, Zhang Y, Song Z, Fu S, Cai Y, Huang X, Fang L, Liu Y, Huang P. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial. Ann Transl Med. 2022 Sep;10(18):989. doi: 10.21037/atm-22-4091.
PubMed 36267757
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
- ClinicalTrials.gov ID
- NCT03439904
- Acronym / sponsor ID
- ECCOPG-003
- Conditions
- Cancer Pain
- Keywords
- pharmaceutical care, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 20 Feb 2018 (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.
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients
Detailed description
This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmaceutical care intervention group | Experimental | Other: Pharmaceutical carePatients will receive individualized pharmaceutical care in addition to usual medical care |
| control group | No intervention | –Patients will receive usual medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or older;
- Histologically confirmed solid tumor;
- Diagnosed chronic cancer pain;
- Opioid-tolerant patients;
- Overall survival is expected to be over 3 months;
Key exclusion criteria (7 listed)
- Patients aged 18 years or older;
- Histologically confirmed solid tumor;
- Diagnosed chronic cancer pain;
- Opioid-tolerant patients;
- Overall survival is expected to be over 3 months;
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 |
|---|---|---|
| Pharmaceutical carePatients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment. | Other | pharmaceutical care intervention group |
Primary outcome
Change in medication adherence
Time frame: Change from baseline at 1 month
The investigators will measure the change in medication adherence via Morisky Scale from baseline to 1 months. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.
4 secondary outcomes
Change in pain score
Time frame: Change from baseline pain score at 1 month
Change in quality of life
Time frame: Change from baseline quality of life at 1 month
Change in patients' knowledge of cancer pain and analgesics
Time frame: Change from baseline knowledge at 1 month
Incidence of adverse events [safety and tolerability]
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 36267757Ding H, Song Y, Wu N, Zheng X, Wei Q, Sun Y, Xie R, Zhai Q, Xu S, Qi Y, Wang Y, Li H, Yang L, Fan Q, Zhao Q, Chen J, Shi J, Duan C, Du Q, Zhang Y, Song Z, Fu S, Cai Y, Huang X, Fang L, Liu Y, Huang P. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial. Ann Transl Med. 2022 Sep;10(18):989. doi: 10.21037/atm-22-4091.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Cancer Pain, run by Zhejiang Cancer 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 7 inclusion and 7 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 15 Jan 2019. 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.
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 Ping Huang (+86-571-88122118, huangping1841@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence (time frame: Change from baseline at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439904, which also lists 1 linked publication.
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 15 Jan 2019.