NCT02825810

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

5.6 years

First QC Date

July 4, 2016

Last Update Submit

November 15, 2025

Conditions

Keywords

breast cancerlong-term survivalmotor controlcervical pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Craniocervical Flexion Test (CCFT)

    Participants will be followed over 9 weeks

  • Algometry

    Participants will be followed over 9 weeks

  • Visual Analogue Scale (VAS)

    Participants will be followed over 9 weeks

  • Scale for Mood Assessment

    Participants will be followed over 9 weeks

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Cervical motor control group

EXPERIMENTAL
Behavioral: Cervical motor control

Control group

NO INTERVENTION

Interventions

Intervention will consist in a tailored exercise training following a previous published motor control protocol

Cervical motor control group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsNeck Pain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Irene Cantarero-Villanueva, PhD

    Physical Therapy Deparment, Faculty of Health Sciences, University of Granada

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations