Clinical trial NCT02825810: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast cancer
long-term survival
motor control
cervical pain
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Participants will be followed over 9 weeks
Secondary outcomes:
measure: Craniocervical Flexion Test (CCFT)
timeFrame: Participants will be followed over 9 weeks
measure: Algometry
timeFrame: Participants will be followed over 9 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: Participants will be followed over 9 weeks
measure: Scale for Mood Assessment
timeFrame: Participants will be followed over 9 weeks
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0
timeFrame: Participants will be followed over 9 weeks
measure: European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: Participants will be followed over 9 weeks
measure: Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)
timeFrame: Participants will be followed over 9 weeks
measure: International Fitness Scale (IFIS)
timeFrame: Participants will be followed over 9 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
name: Irene Cantarero-Villanueva, PhD
role: PRINCIPAL_INVESTIGATOR
References: