Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer

Conditions

Peripheral Neuropathy, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7

Being tested

Educational Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration

Medical subject headings

Peripheral Nervous System Diseases, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Educational InterventionOther

  Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

  Attend a therapy session

• Exercise InterventionBehavioural

  Complete exercise

• Quality-of-Life AssessmentOther

  Also called Quality of Life Assessment

  Ancillary studies

• Questionnaire AdministrationOther

  Ancillary studies

• Survey AdministrationOther

  Ancillary studies

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire

   The McGill Pain Questionnaire-Short Form (MPQ-SF). The purpose of the MPQ-SF is to rate qualities and intensities of pain. Fifteen words describe pain and the subject rates the pain words using a 4-point Likert scale. A visual analogue scale is used to identify intensity of pain and symptoms are rated on current and length of pain. The MPQ-SF has been shown to be a valid and reliable tool in the assessment of pain and specifically the assessment of cancer pain.7.8,9 The Breast Edge Task Force Outcomes Committee rated the MPQ-SF as "highly recommend" for use in the breast cancer population.

   Measured: Up to 2 years

2. Evaluate patients using post-test scores on the CIPN-20

   The purpose of the CIPN-20 is to identify quality of life. Twenty items are used to identify symptoms and functional limitations related to CIPN. Three subscales represent sensory, motor, and autonomic function and provide a more complete picture of the nature, frequency, and severity of CIPN. The CIPN-20 is a multidimensional scale that was specifically developed to capture patients' symptoms and functional limitations as related to CIPN 11,12. The CIPN-20 is best utilized when combined with other pain and quality of life tools.

   Measured: Up to 2 years

3. Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores

   The purpose of the Quick-DASH is to measure physical function and symptoms of persons with musculoskeletal disorders of the upper limb. 3 It is a shortened version of the DASH, using 11 items instead of 30. In the breast cancer population, the DASH has shown good outcome measures when testing physical, social and psychological concerns.13,14 The DASH is highly recommended in the breast cancer population and the Quick DASH is also recommended but has not been used as frequently in research.

   Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Jun 2018
2. Study start2 Jul 2015
3. Primary completion8 Feb 2018
4. Study completion14 Sep 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.