Clinical Classification of Pain in Breast Cancer Survivors

Completed

• Conditions: Breast Cancer; Chronic Pain; Cancer Pain

• Registration Number: NCT04219072
• Lead Sponsor: Kutahya Health Sciences University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2023-07-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-10-28
• Status Verified: 2023-11
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory	10 minute	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.
Short Form 36	10 minute	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.
Numeric Pain Rating Scale	1 minute	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).
Margolis Pain Diagram	5 minute	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

Secondary Outcome Measures

Name	Time	Method
Quantitative sensory test	10 minute	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).

Trial Locations

Locations (1)

KutahyaMSU; 🇹🇷 Kütahya, Kutahya Health Sciences University, Turkey