Cervical Motor Control in Long-term Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT02825810|
Recruitment Status : Suspended (No funding issues, poor prevalence of low cervical motor control)
First Posted : July 7, 2016
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Behavioral: Cervical motor control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||February 2019|
|Experimental: Cervical motor control group||
Behavioral: Cervical motor control
Intervention will consist in a tailored exercise training following a previous published motor control protocol
|No Intervention: Control group|
- Neck Disability Index (NDI) [ Time Frame: Participants will be followed over 9 weeks ]It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items
- Craniocervical Flexion Test (CCFT) [ Time Frame: Participants will be followed over 9 weeks ]It is used to assess deficit of cervical motor pattern
- Algometry [ Time Frame: Participants will be followed over 9 weeks ]Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)
- Visual Analogue Scale (VAS) [ Time Frame: Participants will be followed over 9 weeks ]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
- Scale for Mood Assessment [ Time Frame: Participants will be followed over 9 weeks ]It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 [ Time Frame: Participants will be followed over 9 weeks ]It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures
- European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) [ Time Frame: Participants will be followed over 9 weeks ]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
- Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) [ Time Frame: Participants will be followed over 9 weeks ]It is used to calculate energy expenditure for leisure time physical activity
- International Fitness Scale (IFIS) [ Time Frame: Participants will be followed over 9 weeks ]It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825810
|University of Granada|
|Granada, Spain, 18016|
|Principal Investigator:||Irene Cantarero-Villanueva, PhD||Physical Therapy Deparment, Faculty of Health Sciences, University of Granada|