Cervical Motor Control in Long-term Breast Cancer Survivors

Study Overview
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Brief Summary
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The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.

Detailed Description
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Background: Breast cancer is becoming a common disease; however survival rates have improved throughout the last years. As a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. It is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor. Aim: To determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life. Methods: Fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). The experimental group will receive a nine-week tailored exercise training focused on cervical motor control. Discussion: There is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. Therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.

Official Title
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Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Cervical motor control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be over 18 years old Have passed a period equal o more 5 years since breast cancer diagnosis Have diagnosis of stage I, II or IIIA breast cancer Have signed informed consent Have medical clearance for participation Inability to get level 2 in the craniocervical flexion test Exclusion Criteria: Have diagnosis of arthritis or fibromyalgia Have cancer recurrence Have been operated through previous surgery of cervical column To be taking any treatment for pain or altered motor control during last 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical motor control group<br> | Behavioral: Cervical motor control<br>* Intervention will consist in a tailored exercise training following a previous published motor control protocol<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items | Participants will be followed over 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craniocervical Flexion Test (CCFT) | It is used to assess deficit of cervical motor pattern | Participants will be followed over 9 weeks | 
| Algometry | Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden) | Participants will be followed over 9 weeks | 
| Visual Analogue Scale (VAS) | It is used to assess subjective pain. It contains scores in the range of 0 to 10 (0 = 'no pain'; 10 = 'worst imaginable pain'). Participants will have to mark the level of pain that they feel in that moment for neck-shoulders areas | Participants will be followed over 9 weeks | 
| Scale for Mood Assessment | It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items | Participants will be followed over 9 weeks | 
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 | It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures | Participants will be followed over 9 weeks | 
| European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) | It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing disease symptoms, side effects of treatment, body image, sexual functioning, and future perspective | Participants will be followed over 9 weeks | 
| Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) | It is used to calculate energy expenditure for leisure time physical activity | Participants will be followed over 9 weeks | 
| International Fitness Scale (IFIS) | It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility | Participants will be followed over 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, long-term survival, motor control, cervical pain