Chronic Cancer PainNCT03546023
Brief Pain Inventory to Assess Cancer Pain and Quality of Life
An observational study of Chronic Cancer Pain, run by Tata Memorial Hospital at 2 sites in India.
Trial summary
Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cancer Pain
- What is being tested?
- Patient Interview
- How many people
- 900 participants
- Where
- 2 sitesIndia
- Study dates
- 5 Jun 2018to 4 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients attending the Pain Clinic over a period of 12 months aged 18 years and more.
Who may be able to join
- All patients registered in chronic pain OPD for 12 months from the date of approval of the study by IEC, at Tata Memorial Hospital.
- Age ≥ 18 years
Who cannot join
- Incomplete BPI forms.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Tata Memorial Centre
Mumbai, Maharashtra, 400010
Tata Memorial Centre
Mumbai, Maharashtra, 400025
About this study
Official title: Assessment of Quality of Life in Patients With Chronic Cancer Pain Using Brief Pain Inventory. A Prospective Observational Study
Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their concentration and focus, and 67% excessive reliance on others. Only 34% reported a good quality of life. Effective pain management may help the patient to focus on the positive aspects of life, decreasing the focus on pain and also promote better adherence to reasonable treatment plans. Hence the emphasis is on improving the Quality of Life and not mere pain control.
Read the detailed description
This is a Prospective Observational Study. All new patients in chronic pain OPD are been administered BPI questionnaire as a standard of practice in our institute, in the language best understood by them e.g. English, Hindi, Marathi, Bengali. The participants will be asked to complete it once during their first visit to the pain clinic, before the start of treatment or ongoing treatment for pain (Baseline) and then during subsequent visits (Follow up). Most chronic pain patients are advised to follow-up by one to two weeks. Patients who are willing to participate in the study will be included after obtaining an informed consent. Data will be collected from BPI, Chronic Pain Record form and EMR and will be analyzed. Demographic data, diagnosis, pain data sheet, drug treatment as well as other form of therapies will be recorded. There will be no direct communication with the patient and data of quality of life will be retrieved from pain clinic records.
The Brief Pain Inventory (BPI) long form and short form questionnaire is a validated multidimensional pain assessment tool developed by Cleeland and Ryan. It is one of the most commonly used measures for assessing both pain severity and interference with functions in adults with cancer, thereby satisfying two recommendations (assessment of pain to include both intensity and interference) set by the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) group. It is brief, self administered, easily understood and can be administered to large numbers of patients,.
It contains three questions regarding pain intensity and seven regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain intensity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain. Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The sum of the scores of the pain intensity items represents the summed pain intensity score and the sum of the scores on the pain interference items represents the summed interference score. In addition, the patient enters his pain localization on a body drawing and can give details of his current medication.
- Conditions
- Chronic Cancer Pain
- Being tested
- Patient Interview
- Keywords
- Chronic cancer pain, pain clinic, Brief Pain Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient InterviewOther
BPI scores will be asked by the Doctor or the Research Nurse
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional activity measurement using the Brief Pain Inventory (BPI)
Any change in baseline score of functional activity from BPI during the followup visit.
Measured: followup visit (minimum 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start5 Jun 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Raghu Thota, Tata Memorial Hospital
- Investigators
- Raghu Thota, MD, MNAMS, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546023
- Sponsor's protocol ID
- 1921
- Status last verified
- Sep 2019
- First submitted
- 26 Mar 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Patients With Chronic Cancer Pain Using Brief Pain Inventory. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03546023
- Acronym / sponsor ID
- 1921
- Conditions
- Chronic Cancer Pain
- Keywords
- Chronic cancer pain, pain clinic, Brief Pain Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 6 Jun 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.
Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their concentration and focus, and 67% excessive reliance on others. Only 34% reported a good quality of life. Effective pain management may help the patient to focus on the positive aspects of life, decreasing the focus on pain and also promote better adherence to reasonable treatment plans. Hence the emphasis is on improving the Quality of Life and not mere pain control.
Detailed description
This is a Prospective Observational Study. All new patients in chronic pain OPD are been administered BPI questionnaire as a standard of practice in our institute, in the language best understood by them e.g. English, Hindi, Marathi, Bengali. The participants will be asked to complete it once during their first visit to the pain clinic, before the start of treatment or ongoing treatment for pain (Baseline) and then during subsequent visits (Follow up). Most chronic pain patients are advised to follow-up by one to two weeks. Patients who are willing to participate in the study will be included after obtaining an informed consent. Data will be collected from BPI, Chronic Pain Record form and EMR and will be analyzed. Demographic data, diagnosis, pain data sheet, drug treatment as well as other form of therapies will be recorded. There will be no direct communication with the patient and data of quality of life will be retrieved from pain clinic records.
The Brief Pain Inventory (BPI) long form and short form questionnaire is a validated multidimensional pain assessment tool developed by Cleeland and Ryan. It is one of the most commonly used measures for assessing both pain severity and interference with functions in adults with cancer, thereby satisfying two recommendations (assessment of pain to include both intensity and interference) set by the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) group. It is brief, self administered, easily understood and can be administered to large numbers of patients,.
It contains three questions regarding pain intensity and seven regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain intensity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain. Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The sum of the scores of the pain intensity items represents the summed pain intensity score and the sum of the scores on the pain interference items represents the summed interference score. In addition, the patient enters his pain localization on a body drawing and can give details of his current medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending the Pain Clinic over a period of 12 months aged 18 years and more.
Key inclusion criteria (2 listed)
- All patients registered in chronic pain OPD for 12 months from the date of approval of the study by IEC, at Tata Memorial Hospital.
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Incomplete BPI forms.
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 |
|---|---|---|
| Patient InterviewBPI scores will be asked by the Doctor or the Research Nurse | Other | – |
Primary outcome
Functional activity measurement using the Brief Pain Inventory (BPI)
Time frame: followup visit (minimum 7 days)
Any change in baseline score of functional activity from BPI during the followup visit.
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 11 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Cancer Pain
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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.
Raghu Thota, MD, MNAMS principal investigator
Tata Memorial Hospital
2 sites 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 Hospital at 2 sites 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 1 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional activity measurement using the Brief Pain Inventory (BPI) (time frame: followup visit (minimum 7 days)). 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 11 Sep 2019.