Cervical Motor Control in Long-term Breast Cancer Survivors

Sponsor
Universidad de Granada (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02825810
Collaborator
(none)
0
1
2
67
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cervical motor control
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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 :
Oct 1, 2016
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Craniocervical Flexion Test (CCFT) [Participants will be followed over 9 weeks]

    It is used to assess deficit of cervical motor pattern

  2. Algometry [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) [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 [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 [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) [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) [Participants will be followed over 9 weeks]

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

  8. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Granada Granada Spain 18016

Sponsors and Collaborators

  • Universidad de Granada

Investigators

  • Principal Investigator: Irene Cantarero-Villanueva, PhD, Physical Therapy Deparment, Faculty of Health Sciences, University of Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Irene Cantarero Villanueva, PhD, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT02825810
Other Study ID Numbers:
  • UGR0116
First Posted:
Jul 7, 2016
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Keywords provided by Irene Cantarero Villanueva, PhD, Universidad de Granada
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022