Clinical Classification of Pain in Breast Cancer Survivors

Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain

Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Chronic Pain; Cancer Pain

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Turkey
  • Kutahya Health Sciences University
    • Kütahya, Kutahya Health Sciences University, Turkey, 43000
      • KutahyaMSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The convenience sampling will implement for this cross-sectional study. Breast cancer survivors experiencing chronic pain who presented at the Department of Oncology of Kutahya Health Sciences University Evliya Celebi Hospital will screen for eligibility by their physician and were subsequently requested to participate in this study.

Description

Inclusion Criteria:

• diagnosed with histologically confirmed invasive or non-invasive primary breast cancer
• completed remission and their primary treatment at least 3 months prior to study participation
• experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale

Exclusion Criteria:

• patients affected by other chronic disease,
• severe psychological disorders
• active metastases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	1 minute
Margolis Pain Diagram	The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours	5 minute
Central Sensitization Inventory	The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100. A score of 40 or higher on the CSI means the presence of nociplastic pain.	10 minute
Short Form 36	The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire. SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.	10 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative sensory test	Quantitative sensory testing (QST) is a psychophysical method used to quantify somatosensory function in patients. In QST will be used various stimuli static thermal (thermotest), static mechanical ( a painter brush), pinprick (a calibrated pin) and vibration ( a tuning folk). QST will interrogate whether each stimulus is considered a sensory loss (negative sign) or sensory gain (positive sign or hyperalgesia).	10 minute

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Collaborators: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Chronic Pain; Cancer Pain; Mastodynia
• Other Study ID Numbers: KutahyaMSUcancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No