Cervical Motor Control in Long-term Breast Cancer Survivors
Primary Purpose
Breast Neoplasms
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cervical motor control
Sponsored by

About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring breast cancer, long-term survival, motor control, cervical pain
Eligibility Criteria
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
Sites / Locations
- University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cervical motor control group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Neck Disability Index (NDI)
It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items
Secondary Outcome Measures
Craniocervical Flexion Test (CCFT)
It is used to assess deficit of cervical motor pattern
Algometry
Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)
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
Scale for Mood Assessment
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
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)
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)
It is used to calculate energy expenditure for leisure time physical activity
International Fitness Scale (IFIS)
It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02825810
Brief Title
Cervical Motor Control in Long-term Breast Cancer Survivors
Official Title
Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No funding issues, poor prevalence of low cervical motor control
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer, long-term survival, motor control, cervical pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical motor control group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cervical motor control
Intervention Description
Intervention will consist in a tailored exercise training following a previous published motor control protocol
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items
Time Frame
Participants will be followed over 9 weeks
Secondary Outcome Measure Information:
Title
Craniocervical Flexion Test (CCFT)
Description
It is used to assess deficit of cervical motor pattern
Time Frame
Participants will be followed over 9 weeks
Title
Algometry
Description
Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)
Time Frame
Participants will be followed over 9 weeks
Title
Visual Analogue Scale (VAS)
Description
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
Time Frame
Participants will be followed over 9 weeks
Title
Scale for Mood Assessment
Description
It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items
Time Frame
Participants will be followed over 9 weeks
Title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0
Description
It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures
Time Frame
Participants will be followed over 9 weeks
Title
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Description
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
Time Frame
Participants will be followed over 9 weeks
Title
Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)
Description
It is used to calculate energy expenditure for leisure time physical activity
Time Frame
Participants will be followed over 9 weeks
Title
International Fitness Scale (IFIS)
Description
It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
Time Frame
Participants will be followed over 9 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cantarero-Villanueva, PhD
Organizational Affiliation
Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18016
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Cervical Motor Control in Long-term Breast Cancer Survivors
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