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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
Sponsor:
Information provided by (Responsible Party):
Irene Cantarero Villanueva, 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Cervical motor control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Craniocervical Flexion Test (CCFT) [ Time Frame: Participants will be followed over 9 weeks ]
    It is used to assess deficit of cervical motor pattern

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Spain
University of Granada
Granada, Spain, 18016
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Irene Cantarero-Villanueva, PhD Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
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Responsible Party: Irene Cantarero Villanueva, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02825810    
Other Study ID Numbers: UGR0116
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Keywords provided by Irene Cantarero Villanueva, Universidad de Granada:
breast cancer
long-term survival
motor control
cervical pain
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases