Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Cancer Pain

Pain

Neurologic Manifestations

Quality of Life

Chronic Graft Versus Host Disease

BPI scores will be asked by the Doctor or the Research Nurse

Patient Interview

Raghu Thota, MD, MNAMS

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.

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.

Brief Pain Inventory to Assess Cancer Pain and Quality of Life

Assessment of Quality of Life in Patients With Chronic Cancer Pain Using Brief Pain Inventory. A Prospective Observational Study

Any change in baseline score of functional activity from BPI during the followup visit.

Tata Memorial Hospital

Professor

Neoplasms

Mouth and Tooth Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Headache

Head and Neck Neoplasms

Stomatitis

Mucositis

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Analgesics

Central Nervous System Depressants

Narcotic Antagonists

All Drugs and Chemicals

Buprenorphine

Tramadol

Analgesics, Opioid

Narcotics

The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.

Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.

Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.

Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

Oral Mucositis (OM) Pain App

Stuart J. Wong, MD

This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.

Hypothesis: Long-acting transdermal buprenorphine (FDA-approved dose from 5 mcg to 20 mcg /week) in conjunction with oral tramadol (50mg-400mg) as needed for breakthrough pain would lead to significant reduction in mucositis-related pain in locally advanced head and neck cancer patients being treated with radiation therapy by the end of treatment and follow up period of 12 weeks.

This is a single-arm, interventional, supportive care clinical trial for head and neck cancer patients evaluating role of transdermal (TD) buprenorphine and tramadol combination in alleviating radiation-induced mucositis pain. This will generate preliminary data to test the feasibility and efficacy of study drug regimen. The study will also test the clinical usefulness of the smart phone pain app in recording and reporting radiation induced mucositis pain.

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients: A Pilot Study

The Brief Pain Inventory - Short Form (BPI-sf) is a nine-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity -- 0 being no pain and 10 being the pain as bad as you can imagine (within the previous 24 hours).

The Oral Mucositis (OM) Pain App is a smartphone application that was designed to permit subjects to key in pain severity using a visual analog 0-10 scale. The amount of pain that a subject feels ranges across a continuum from none (0) to an extreme amount of pain (10). The App is programed with an alarm to prompt the patient to record pain severity at prescribed intervals daily and through spontaneous patient input. Compliance is measured by subjects entering in a value four times a day into the OM Pain App.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brief Pain Inventory to Assess Cancer Pain and Quality of Life	NCT03546023	Chronic Cancer ...	Patient Intervi...	18 Years -	Tata Memorial Hospital
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients	NCT04752384	Head and Neck S...	Buprenorphine Tramadol Oral Mucositis ...	18 Years - 80 Years	Medical College of Wisconsin
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients	NCT04752384	Head and Neck S...	Buprenorphine Tramadol Oral Mucositis ...	18 Years - 80 Years	Medical College of Wisconsin

Spots Global Cancer Trial Database for brief pain inventory