Chronic Cancer PainNCT02804477
Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic
An observational study of Chronic Cancer Pain, run by Tata Memorial Centre at 1 site in India.
Trial summary
This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Cancer Pain
- How many people
- 330 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2016to Jan 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting to pain clinic( private and general) will be screened and enrolled according to inclusion and exclusion criteria
Who may be able to join
- All adult patients > 18 yrs. of age
- Patients suffering from chronic pain of any type and severity 3. On opioid i.e. Morphine, taken prescription at least once 4. Who can understand and communicate Hindi
Who cannot join
- Refusal of consent
- Paediatric patients
- Patients who cannot understand or communicate Hindi
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Questionnaire in Pain Clinic
This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Also relationship of various demographic, disease related and opioid related factors to medication adherence.
Read the detailed description
After institutional review board approval, a Pilot study including 30 patients will be conducted to validate Morisky Medication Adherence Scale 8 to validate the questionnaire for cross cultural variation. The data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. Following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate Hindi will be invited to participate in the study. Each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. An informed written consent will be obtained. Data will be collected by PI or co-investigator after obtaining written consent at Pain clinic(general and private) of Tata Memorial Hospital. Fund for purchasing the copyright to use the Hindi translation of Morisky Medication Adherence Scale 8, was provided by the department of Anesthesia Account, Tata Memorial Hospital, after due permission obtained from, Director Tata Memorial Center and Head of the department of Anesthesiology, critical care and pain, Tata Memorial Center. The precise scoring and permission to use the Hindi translation of the scale has been obtained from the developer. For income we will be considering private and general category of the patients respectively.Data will be analyzed using International Business machines software package for statistical analysis version 20.0.Pilot study data will be analyzed applying tests as internal consistency (Cronbach's alfa), Test retest variability and factor analysis.For parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. Chi-square tests and Student's t-tests will used for categorical and continuous variables, respectively. All variables will be unconditionally entered into a binary logistic multi variate analysis. All p values #0.05 will regarded as statistically significant.
- Conditions
- Chronic Cancer Pain
- Keywords
- adherence, opioid, MMAS 8, morisky medication adherence scale, validation
What is being measured
The primary outcome is the main question the study is designed to answer.
validation and assessment of adherence to opioids for chronic cancer pain in pain clinic using Morisky medication adherence scale 8
to do a pilot study comprising of 30 patients for cross cultural validation of Morisky medication adherence questionnaire , if it gets validated then assessment of adherence of patients suffering from chronic cancer pain to opioids.
Measured: six months
Secondary outcomes (1)
relationship of adherence to opioids with demographic characteristics
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Cancer PainStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parmanand Jain, Tata Memorial Centre
- Investigators
- Parmanand Jain, MD, Principal investigator, Professorcharushree E jibhkate, Junior resident, Study chair, Junior resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804477
- Sponsor's protocol ID
- TataMC 1680
- Status last verified
- Apr 2017
- First submitted
- 13 Jun 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Larue F, Colleau SM, Brasseur L, Cleeland CS. Multicentre study of cancer pain and its treatment in France. BMJ. 1995 Apr 22;310(6986):1034-7. doi: 10.1136/bmj.310.6986.1034.
PubMed 7728056van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
PubMed 17355955Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
PubMed 18453793Krousel-Wood M, Hyre A, Muntner P, Morisky D. Methods to improve medication adherence in patients with hypertension: current status and future directions. Curr Opin Cardiol. 2005 Jul;20(4):296-300. doi: 10.1097/01.hco.0000166597.52335.23.
PubMed 15956826
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Questionnaire in Pain Clinic
- ClinicalTrials.gov ID
- NCT02804477
- Acronym / sponsor ID
- TataMC 1680
- Conditions
- Chronic Cancer Pain
- Keywords
- adherence, opioid, MMAS 8, morisky medication adherence scale, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Also relationship of various demographic, disease related and opioid related factors to medication adherence.
Detailed description
After institutional review board approval, a Pilot study including 30 patients will be conducted to validate Morisky Medication Adherence Scale 8 to validate the questionnaire for cross cultural variation. The data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. Following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate Hindi will be invited to participate in the study. Each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. An informed written consent will be obtained. Data will be collected by PI or co-investigator after obtaining written consent at Pain clinic(general and private) of Tata Memorial Hospital. Fund for purchasing the copyright to use the Hindi translation of Morisky Medication Adherence Scale 8, was provided by the department of Anesthesia Account, Tata Memorial Hospital, after due permission obtained from, Director Tata Memorial Center and Head of the department of Anesthesiology, critical care and pain, Tata Memorial Center. The precise scoring and permission to use the Hindi translation of the scale has been obtained from the developer. For income we will be considering private and general category of the patients respectively.Data will be analyzed using International Business machines software package for statistical analysis version 20.0.Pilot study data will be analyzed applying tests as internal consistency (Cronbach's alfa), Test retest variability and factor analysis.For parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. Chi-square tests and Student's t-tests will used for categorical and continuous variables, respectively. All variables will be unconditionally entered into a binary logistic multi variate analysis. All p values #0.05 will regarded as statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting to pain clinic( private and general) will be screened and enrolled according to inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- All adult patients > 18 yrs. of age
- Patients suffering from chronic pain of any type and severity 3. On opioid i.e. Morphine, taken prescription at least once 4. Who can understand and communicate Hindi
Key exclusion criteria (3 listed)
- Refusal of consent
- Paediatric patients
- Patients who cannot understand or communicate Hindi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
validation and assessment of adherence to opioids for chronic cancer pain in pain clinic using Morisky medication adherence scale 8
Time frame: six months
to do a pilot study comprising of 30 patients for cross cultural validation of Morisky medication adherence questionnaire , if it gets validated then assessment of adherence of patients suffering from chronic cancer pain to opioids.
1 secondary outcome
relationship of adherence to opioids with demographic characteristics
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 7728056Larue F, Colleau SM, Brasseur L, Cleeland CS. Multicentre study of cancer pain and its treatment in France. BMJ. 1995 Apr 22;310(6986):1034-7. doi: 10.1136/bmj.310.6986.1034.
- Background: PubMed 17355955van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
- Background: PubMed 18453793Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
- Background: PubMed 15956826Krousel-Wood M, Hyre A, Muntner P, Morisky D. Methods to improve medication adherence in patients with hypertension: current status and future directions. Curr Opin Cardiol. 2005 Jul;20(4):296-300. doi: 10.1097/01.hco.0000166597.52335.23.
- Individual participant dataSharing planned: Undecided
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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.
Parmanand Jain, MD principal investigator
Professor
charushree E jibhkate, Junior resident study chair
Junior resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cancer Pain, run by Tata Memorial Centre at 1 site in India.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Apr 2017. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation and assessment of adherence to opioids for chronic cancer pain in pain clinic using Morisky medication adherence scale 8 (time frame: six months). 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 NCT02804477, which also lists 4 linked publications.
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 26 Apr 2017.