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Cervical Motor Control in Long-term Breast Cancer Survivors

Not Applicable
Withdrawn
Conditions
Breast Neoplasms
Interventions
Behavioral: Cervical motor control
Registration Number
NCT02825810
Lead Sponsor
Universidad de Granada
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cervical motor control groupCervical motor control-
Primary Outcome Measures
NameTimeMethod
Neck Disability Index (NDI)Participants will be followed over 9 weeks

It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items

Secondary Outcome Measures
NameTimeMethod
Craniocervical Flexion Test (CCFT)Participants will be followed over 9 weeks

It is used to assess deficit of cervical motor pattern

Visual Analogue Scale (VAS)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

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0Participants 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

Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)Participants will be followed over 9 weeks

It is used to calculate energy expenditure for leisure time physical activity

AlgometryParticipants will be followed over 9 weeks

Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)

Scale for Mood AssessmentParticipants will be followed over 9 weeks

It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items

International Fitness Scale (IFIS)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

European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)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

Trial Locations

Locations (1)

University of Granada

🇪🇸

Granada, Spain

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