Peripheral Nervous System DiseasesSONICSNCT02760654

Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy

A study testing Proactive Self Management Program for Effects of Cancer Treatment in people with Peripheral Nervous System Diseases and Pain Management, run by University of Michigan at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 years and older
Conditions the study is for: Peripheral Nervous System Diseases, Pain Management, Self Management
What is being tested?: Proactive Self Management Program for Effects of Cancer Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: Apr 2016to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

over 25 years of age
self-report 4/10 worst CIPN pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen
have at least grade one sensory CIPN as defined by their oncology provider using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
have a stable analgesic medication regimen as evidenced by a less than 10% increase or decrease in their analgesic medication dosage in the two weeks leading up to their enrollment in the study
have internet access
self-report the ability to use a computer
signed informed consent
willingness to participate in all study activities.

Who cannot join

prognosis of less than three months
documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, Central Nervous System malignancy, vitamin B deficiency, hereditary, nerve compression injury)
neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study
have participated in cognitive behavioral pain management in the past or plan to enroll in cognitive behavioral pain management during the course of the intervention.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Michigan
Ann Arbor, Michigan, 48109
St. Joseph Mercy Canton
Canton, Michigan, 48188
St. Joseph Mercy Chelsea
Chelsea, Michigan, 48118
St. Joseph Mercy Livingston
Howell, Michigan, 48843
St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48104

Other trials in United States

About this study

The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an online cognitive behavioral pain management website called Proactive Self-Management Program for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to explore the mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression, and sleep disturbance on worst pain intensity. Another aim of this study is to determine whether PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and tingling), average pain severity, and physical impairment. Lastly, since this intervention has never been tested in individuals with painful CIPN, the investigators will assess patients' perceptions of acceptability and satisfaction with the intervention.

Conditions: Peripheral Nervous System Diseases, Pain Management, Self Management
Being tested: Proactive Self Management Program for Effects of Cancer Treatment
Medical subject headings: Peripheral Nervous System Diseases, Agnosia

What participants receive

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

Proactive Self Management Program for Effects of Cancer TreatmentDevice

Study groups in NCT02760654
Study group	Role	What they receive
Online Self Management	Experimental	Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want. Receives: Device: Proactive Self Management Program for Effects of Cancer Treatment
Control	No intervention	Treatment as usual

What is being measured

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

Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
Measured: Baseline to 8 weeks

Secondary outcomes (9)

Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks
The PROMIS short form emotional distress depression 4a Scores are measured on a scale whose lowest possible score is 41.0 and highest is 79.4 where 41 is no emotional distress and 79.4 is extreme distress.
Measured: Baseline to 8 weeks
PROMIS Short Form Anxiety 4a
The PROMIS Short Form Anxiety 4a is scored on a scale of 40.3 - 81.6, with a score of 40.3 meaning no anxiety and a score of 81.6 meaning high anxiety.
Measured: Baseline to 8 weeks
Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks
The PROMIS Short Form Fatigue 4a is scored on a scale of 33.7 to 75.8, with a score of 33.7 meaning no fatigue and a score of 75.8 meaning high fatigue.
Measured: Baseline to 8 weeks
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks
The PROMIS Short Form Sleep-Related Impairment 8a is scored on a scale of 30.0 to 80.1 with a score of 30.0 meaning no sleep-related impairment and a score of 80.1 meaning a high degree of impairment in daily activities due to poor sleep.
Measured: Baseline to 8 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Measured: 8 week
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks
The 0 - 10 Average Pain Intensity Numerical Rating Scale was scored on a scale of 0 - 10, with a score of 0 meaning no pain, and a score of 10 meaning worst pain imaginable.
Measured: Baseline to 8 weeks
Adapted Acceptability E-Scale
The Adapted Acceptability E- Scale contains 7 items that are scored on a 1 - 5 scale, with a score of 1 representing low ratings of acceptability and satisfaction with the online self management program, and a score of 5 representing high ratings of acceptability and satisfaction with the online self management program. This measure was only administered to individuals participating in the online self management program.
Measured: 8 week
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
The European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy contains three subscales: Sensory, Motor, and Autonomic. Each subscale is scored on a scale of 0 - 100, with a score of 0 representing no neuropathy symptoms and functional impairment due to neuropathy, and a score of 100 represents severe neuropathy symptoms and functional impairment due to neuropathy. Only the Sensory and Motor subscales were used in this current study.
Measured: Baseline to 8 weeks
Change in PROMIS Pain Interference 4a Scores at 8 Weeks
The PROMIS Pain Interference 4a is scored on a scale of 41.6 to 75.6, with a score of 41.6 meaning little or no interference with daily activities due to pain severity, and a score of 75.6 meaning a high degree of interference with daily activities due to pain severity.
Measured: Baseline to 8 weeks

Timeline

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

Apr 2016Dec 2016

First posted3 May 2016 (estimated)
Study startApr 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Nervous System DiseasesStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02760654
Sponsor's protocol ID: HUM00104185
Acronym: SONICS
Status last verified: Oct 2017
First submitted: 28 Apr 2016
Last updated: 13 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Nervous System Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT02760654
Acronym / sponsor ID: SONICS / HUM00104185
Conditions: Peripheral Nervous System Diseases, Pain Management, Self Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: St. Joseph Mercy Health System
Study start: Apr 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 3 May 2016 (estimated)
Results: Posted 2 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Online Self Management	Experimental	Device: Proactive Self Management Program for Effects of Cancer TreatmentParticipants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Control	No intervention	–Treatment as usual

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

over 25 years of age
self-report 4/10 worst CIPN pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen
have at least grade one sensory CIPN as defined by their oncology provider using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
have a stable analgesic medication regimen as evidenced by a less than 10% increase or decrease in their analgesic medication dosage in the two weeks leading up to their enrollment in the study
have internet access

Key exclusion criteria (4 listed)

prognosis of less than three months
documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, Central Nervous System malignancy, vitamin B deficiency, hereditary, nerve compression injury)
neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study
have participated in cognitive behavioral pain management in the past or plan to enroll in cognitive behavioral pain management during the course of the intervention.

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
Proactive Self Management Program for Effects of Cancer Treatment	Device	Online Self Management

Primary outcome

Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
Time frame: Baseline to 8 weeks
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.

9 secondary outcomes

Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks
Time frame: Baseline to 8 weeks
PROMIS Short Form Anxiety 4a
Time frame: Baseline to 8 weeks
Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks
Time frame: Baseline to 8 weeks
Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks
Time frame: Baseline to 8 weeks
Patient Global Impression of Change
Time frame: 8 week
Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks
Time frame: Baseline to 8 weeks
Adapted Acceptability E-Scale
Time frame: 8 week
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks
Time frame: Baseline to 8 weeks
Change in PROMIS Pain Interference 4a Scores at 8 Weeks
Time frame: Baseline to 8 weeks

Results and safety

Results posted to the registry on 2 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Online Self Management	30	23
Control	30	24

Primary outcome: Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks

Time frame: Baseline to 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Online Self Management n = 19	Control n = 19
Value	-0.94 (1.36)	0 (1.31)

Online Self Management vs Control: p <0.05, ANCOVA

Population analysed: Only 19 people in each arm out of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 are analyzed.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the Baseline (Time of randomization) to the Week 8 (Final) time points.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Online Self Management	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Control	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): Small sample size, high drop out, lack of active monitoring of intervention usage, lack of generalizability to any specific type of chronic painful neuropathy, and changes in pain medications during the trial may have confounded the primary analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Peripheral Nervous System Diseases

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Active, not recruiting
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RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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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.

Robert Knoerl, PhD, RN principal investigator

University of Michigan

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 4 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760654.

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 13 Nov 2017.