Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors

NCT04965909 | Unknown

• 1 other identifier: 0379520202023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Pain stands out among the sequelae that affect the quality of life of breast cancer survivors. Pain neuroscience education and graded exposure to movement are therapeutic approaches that have been shown to be effective in the management of chronic pain in other populations. However, there are no previous studies that combine them in this population. Objective: To evaluate the effectiveness of an online physiotherapy focused-person program which combines pain neuroscience education and graded exposure to movement, to improve the quality of life of breast cancer survivors. Methodology: The design of the study is a randomised controlled clinical trial and the sample will be 40 breast cancer survivors with pain in the last 6 months. A random method will be used to assign participants into two groups (experimental and control). The evaluator and statistician will be blinded to participant allocation while the experimental group will receive the therapeutic program which combines pain neuroscience education and graded exposure to movement-based intervention throughout therapeutic yoga; the control will be a passive group. There will be four points of assessment: the main outcome assessed will be quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the secondary outcomes are variables related to pain experience (catastrophising, self-efficacy, kinesiophobia and fear-avoidance behaviours). All will be assessed using validated methods. SPSS program will be used for the data analysis. A mixed-model analyses of variance ANOVA (2x4) will be used to study the effects of the treatment on the dependent variables. An intention-to-treat analysis will be performed. All statistical tests will be performed considering a confidence interval of 95%. Trial record: NCT04965909.

Conditions

Breast Neoplasms; Pain, Chronic; Quality of Life

Keywords

breast cancer; pain; quality of life; pain neuroscience education; graded exposure to movement; therapeutic exercise

Outcome Measures

Primary Outcomes (1)

• Change from quality of life

  Quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4). The FACT-B+4 is a 41-item instrument designed to measure six domains of QOL in breast cancer patients: Physical, social, emotional and functional well-being, and breast-cancer (BCS) and lymphedema (ARM) subscales. The score obtained ranges from 0-148 points. The ARM subscale was not included in the total score. A higher score translates into a better quality of life.

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

Secondary Outcomes (5)

• Change from pain intensity

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

• Change from catastrophism level

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

• Change from self-efficacy level

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

• Change from Kinesiophobia

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

• Change from Fear Avoidance Beliefs

  Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).

Study Arms (2)

Educational and therapeutic exercise program

EXPERIMENTAL

Participants will receive a 3-month online physiotherapy program comprised of 'pain neuroscience education' (month 1) and 'gradual exposure to movement' (month 2 and 3). They will receive an informative booklet online.

Other: Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement.

Passive control group (usual care)

NO INTERVENTION

Participants will receive the 'usual care'. They will receive an informative booklet online and the possibility of receiving the therapeutic program, once the study is completed.

Interventions

Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement. OTHER

Online group therapeutic program (small groups), applied for 3 months.

Educational and therapeutic exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman aged between 18 - 65 years.
• Diagnosis of stage 0 - III breast cancer.
• Primary treatment (surgery, radiotherapy and chemotherapy) completed at least 3 months ago may still be receiving hormonal therapy.
• Pain related to primary treatment in the last 6 months.
• Access to Internet and an electronic device that allows the use of the applications used in this study and skills for their use or assistance from a close person who has them.
• Ability to communicate fluently verbally and in writing in the language of the research team (Spanish).
• Approval of participation in the study by the coordinator of the health team that assisted her during the course of cancer and its treatment.

You may not qualify if:

• Another previous type of cancer or breast cancer recurrence in a period of less than 1 year.
• Medical diagnosis of a neurological, autoimmune or cardiovascular disease.
• Some type of pathology that is associated with a contraindication to physical exercise.
• Diagnosis of serious psychiatric or neurologic disorders that do not allow the participant to follow orders.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universidad de Sevilla, departamento de Fisioterapia

Seville, 41009, Spain

RECRUITING

Related Publications (6)

• Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.

  PMID: 30831273 BACKGROUND

• De Groef A, Penen F, Dams L, Van der Gucht E, Nijs J, Meeus M. Best-Evidence Rehabilitation for Chronic Pain Part 2: Pain during and after Cancer Treatment. J Clin Med. 2019 Jul 5;8(7):979. doi: 10.3390/jcm8070979.

  PMID: 31284377 BACKGROUND

• Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10.1002/14651858.CD010802.pub2.

  PMID: 28045199 BACKGROUND

• Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581.

  PMID: 17592957 BACKGROUND

• Martinez-Miranda P, Jimenez-Rejano JJ, Munoz-Fernandez MJ, Garcia-Munoz C, Casuso-Holgado MJ. Effectiveness of an interactive online group intervention based on pain neuroscience education and graded exposure to movement in breast cancer survivors with chronic pain: a randomised controlled trial. Support Care Cancer. 2024 Oct 7;32(10):705. doi: 10.1007/s00520-024-08887-4.

  PMID: 39373766 DERIVED

• Martinez-Miranda P, Casuso-Holgado MJ, Garcia-Munoz C, Munoz-Fernandez MJ, Jimenez-Rejano JJ. Online pain neuroscience education and graded exposure to movement in breast cancer survivors: protocol of a randomized controlled trial. Front Med (Lausanne). 2024 Feb 28;11:1355964. doi: 10.3389/fmed.2024.1355964. eCollection 2024.

  PMID: 38482528 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Martínez Miranda

CONTACT

620278275; patrimartinez37@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind (researcher and statistician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoranda Programa del Doctorado Interuniversitario en CCSS

Model Details: A Randomized Controlled Clinical Trial of two groups (experimental and control) will be carried out.

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 16, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)