Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic

Chronic Cancer Pain Clinical Trial

Official title:

Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Questionnaire in Pain Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804477
• Other study ID #: TataMC 1680
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: April 25, 2017
• Start date: June 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Also relationship of various demographic, disease related and opioid related factors to medication adherence.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. All adult patients > 18 yrs. of age

2. 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

Exclusion Criteria:

1. Refusal of consent

2. Paediatric patients

3. Patients who cannot understand or communicate Hindi

Related Conditions & MeSH terms

• Chronic Cancer Pain
• Pain

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

References & Publications (4)

Krousel-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. Review. — View Citation

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. — View Citation

Morisky 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. — View Citation

van 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. Epub 2007 Mar 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months
Secondary	relationship of adherence to opioids with demographic characteristics		six months