Cervical Motor Control in Long-term Breast Cancer Survivors

Breast Neoplasms Clinical Trial

Official title:

Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02825810
• Other study ID #: UGR0116
• Status: Withdrawn
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Cervical motor control
Intervention will consist in a tailored exercise training following a previous published motor control protocol

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI)	It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items	Participants will be followed over 9 weeks
Secondary	Craniocervical Flexion Test (CCFT)	It is used to assess deficit of cervical motor pattern	Participants will be followed over 9 weeks
Secondary	Algometry	Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)	Participants will be followed over 9 weeks
Secondary	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	Participants will be followed over 9 weeks
Secondary	Scale for Mood Assessment	It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items	Participants will be followed over 9 weeks
Secondary	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	Participants will be followed over 9 weeks
Secondary	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	Participants will be followed over 9 weeks
Secondary	Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)	It is used to calculate energy expenditure for leisure time physical activity	Participants will be followed over 9 weeks
Secondary	International Fitness Scale (IFIS)	It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility	Participants will be followed over 9 weeks