Peripheral NeuropathyNCT03568526
Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer
A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Peripheral Neuropathy and Stage I Breast Cancer AJCC v7, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Neuropathy, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
- What is being tested?
- Educational Intervention, Exercise Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2015to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
- Taxane-based chemotherapy for early stage breast cancer
- Diagnosis of early stage breast cancer
Who cannot join
- Individuals with late stage breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
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
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.
OUTLINE:
Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (sensorimotor rehabilitation program) | Experimental | Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks. Receives: Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted26 Jun 2018
- Study start2 Jul 2015
- Primary completion8 Feb 2018
- 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.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Darragh, Ohio State University Comprehensive Cancer Center
- Investigators
- Amy Darragh, PhD, OTR/L, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568526
- Sponsor's protocol ID
- OSU-14219
- Other IDs
- NCI-2017-01583
- Status last verified
- Oct 2022
- First submitted
- 20 Mar 2018
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03568526
- Acronym / sponsor ID
- OSU-14219
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.
OUTLINE:
Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (sensorimotor rehabilitation program) | Experimental | Other: Educational Intervention, Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
- Taxane-based chemotherapy for early stage breast cancer
- Diagnosis of early stage breast cancer
Key exclusion criteria (1 listed)
- Individuals with late stage breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend a therapy session | Other | Supportive Care (sensorimotor rehabilitation program) |
| Exercise InterventionComplete exercise | Behavioural | Supportive Care (sensorimotor rehabilitation program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (sensorimotor rehabilitation program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (sensorimotor rehabilitation program) |
| Survey AdministrationAncillary studies | Other | Supportive Care (sensorimotor rehabilitation program) |
Primary outcome
Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire
Time frame: Up to 2 years
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.
Evaluate patients using post-test scores on the CIPN-20
Time frame: Up to 2 years
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.
Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores
Time frame: Up to 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Darragh, PhD, OTR/L principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Peripheral Neuropathy and Stage I Breast Cancer AJCC v7, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.