CIPN - Chemotherapy-Induced Peripheral NeuropathyNCT05556447
Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A study testing Internet delivered pain coping skills training in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Wake Forest University Health Sciences.
Trial summary
This is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Internet delivered pain coping skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a documented diagnosis of invasive cancer (of any type) requiring neurotoxic chemotherapy (alone, in combination, or in conjunction with surgery or radiation). Individuals with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
- Must have clinical symptoms of Grade 2 or Grade 3 peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events), AND clinically documented chemotherapy-induced peripheral neuropathy (CIPN) following treatment with any single or combined neurotoxic chemotherapy (i.e., platinums, vinca alkaloids, taxanes, or proteasome inhibitors).
- Must have been ≥24 months since the time in which neurotoxic chemotherapy was first initiated (i.e., time since the first administration of neurotoxic chemotherapy), and either no evidence of residual disease or with stable disease, as established by imaging/clinical exam/laboratory testing.
- Must have completed all planned anticancer therapy (with the exception of maintenance therapy when appropriate). Maintenance therapy includes planned chronic immunotherapy, hormonal therapy, targeted therapy to prevent recurrence of disease rather than to treat active disease. Individuals on maintenance therapy and actively receiving chemotherapy drugs are not eligible. Time frame applies to most recent completion of chemotherapy treatment if participant has experienced cancer recurrence(s).
- Must report a score of ≥ 4 on the single item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (1a) scale.
- Must report experiencing symptoms of pain, physical suffering, or discomfort, of any intensity, on at least "Most Days" of the week on the Graded Chronic Pain Scale Revised (Abbreviated).
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- Must be on a stable medication regimen (i.e., no changes to prescribed analgesic or neuropathic pain medication regimens) over a period of at least 30 days prior to enrollment, and no upward dose titrations during the intervention period, including: opioid analgesics (i.e., hydrocodone, oxycodone, tramadol, etc), duloxetine (i.e., Cymbalta), pregabalin (e.g., Lyrica), gabapentin (e.g., Neurontin, Gralise). Changes to prescriptions during the study should only occur if advised by a participant's doctor. Unexpected adjustments to prescriptions due unforeseen clinical need are allowable at any time.
- Must be expected to be able to complete all study activities according to the treating/referring clinician.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Age 18 or older at the time of study entry.
- Must be able to speak, read, and understand English.
Who cannot join
- Has a disability or condition that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment; diagnosis or clinical evidence of severe psychiatric disorder; diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
- Reports only preexisting pain conditions deemed unrelated to CIPN (e.g., migraine headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
- Has symptoms of preexisting neuropathy prior to treatment with neurotoxic chemotherapy (i.e., self-reported or documented history of unresolved or pre- existing peripheral neuropathy due to diabetes, HIV, or other conditions known to be unrelated to chemotherapy treatment).
- Has a known or suspected diagnosable substance use disorder (according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria) or is actively receiving treatment for one, per patient report or documented in the medical record.
- Currently being prescribed buprenorphine or suboxone.
- Suspected or proven progressive cancer by clinical history, exam or imaging evaluation.
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- Enrolled in hospice care or end-of-life palliative care.
- No reliable access to Internet, wi-fi, or compatible device, and declines the Tablet Lending Program.
- Does not have a working email address.
About this study
Official title: Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Outcomes and Exploration of Mechanisms
This is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Also proposed is a secondary focus on subjective and objective function, medication use, psychological distress, and coping.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a sensory polyneuropathy occurring in 50-75% of patients receiving neurotoxic chemotherapy that presents with varying degrees of paresthesia, dysesthesia, allodynia, hyperalgesia, and pain. For 30% of survivors, CIPN remains for a lifetime, often accompanied by morbidity, increased healthcare utilization, impaired functional and psychological status, strained relationships, and reduced quality of life. CIPN patients often present with multiple patterns of peripheral neuropathy owing to diversity in their causative etiologies, environmental factors, and patient-specific pathophysiology. Recent studies call for a shift in focus from solely etiologic characterization (e.g. drug mechanism based) to individual pain phenotyping that characterizes CIPN patients based on the reaction of the nervous system (e.g. pain processing). Given its high prevalence, complex presentation, absence of effective prevention, and few established therapies for addressing long-term symptoms, CIPN poses a major burden to patients/providers. Better understanding of CIPN's underlying biological and psychosocial mechanisms paired with enhanced access to effective interventions may lead to improved CIPN management. Cognitive behavioral pain coping skills training (PCST) has shown effectiveness for reducing pain-related suffering among patients with cancer pain as well as those experiencing various neuropathic symptoms-they target specific psychological processes known to contribute to pain, distress, and disability. Despite established effectiveness, in-person PCST interventions often are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, and travel requirements. There remains a need for evidence-based behavioral pain interventions for CIPN delivered with innovative methods to overcome treatment access barriers, reduce pain interference, and enhance quality of life/functioning. We developed an 8-week internet-delivered PCST program using an expert systems approach designed to retain essential features of in-person PCST that does not require therapist involvement-a concept increasingly important for providing socially-distant care amid the corona virus disease (COVID-19) pandemic. The published small trials investigating PCST for CIPN demonstrates promise of this approach for reducing the CIPN burden and justifies larger-scale testing of internet-based PCST for CIPN.
- Being tested
- Internet delivered pain coping skills training
- Keywords
- paresthesia, dysesthesia, allodynia, hyperalgesia
- Medical subject headings
- Paresthesia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet delivered pain coping skills trainingBehavioural
Also called PCST
Participants in the intervention group will complete 8 weeks of pain coping skills training delivered online
| Study group | Role | What they receive |
|---|---|---|
| Internet delivered pain coping | Experimental | 8 week online pain coping skills training program with weekly, 45-minute modules guided by an automated coach Receives: Behavioral: Internet delivered pain coping skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate
Participant adherence in the pilot trial will be measured individually based on the number of modules completed, of the 8 possible modules, during the 12 week intervention period. Participants who complete 6 of the 8 modules will be considered "completers" of the program, though the percent adherence to the program would be 75%.
Measured: Week 12
Retention Rate
Participant retention in the pilot trial will be based on the percentage of all participants that are retained in the trial overtime. If 100% of participants complete 100% of the modules, this would equate to a 100% retention rate.
Measured: Week 12
Acceptability of the Intervention
Acceptability will be assessed based on two indicators: the ability to recruit the desired number of participants into the trial during the specified recruitment period (26 total participants) and based on assessments of participant satisfaction with the program. Participant satisfaction will be assessed via satisfaction surveys developed specifically for the online pain coping skills training intervention, with questions scored on a likert scale ranging from "not at all satisfied" to "very satisfied" for each unique aspect of the program.
Measured: Week12
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Measured: baseline
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Measured: Week 12
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Measured: Week 24
Pain Interference Score
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Measured: Week 36
Secondary outcomes (8)
Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b - Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Medication and substance amount use
Medication and substance use will be monitored with diaries completed at multiple timepoints during the study, and using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS). The TAPS assesses substance use behaviors over the last 12 months.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - PROMIS Cognitive Function scale
Psychological distress will be assessed via the PROMIS Cognitive Function scale, a 4-item questionnaire that asks participants to report on how often they have experienced certain thoughts and cognitive processes over the last 7 days, scored on a likert scale from "never" to "very often".
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)
Psychological distress will be assessed via the General Anxiety Disorder scale (GAD 7) - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - Patient Health Questionnaire (PHQ 8)
Psychological distress will be assessed via the Patient Health Questionnaire (PHQ 8) - Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) -Total score ≥3 for first 2 questions suggests anxiety -Total score ≥3 for last 2 questions suggests depression.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Coping
Coping will be assessed via questionnaire designed specifically for the internet-based pain coping skills program featured in the intervention. Questions pertain to how well participants feel that have developed adaptive coping strategies related to their pain coping processes, as well as how often they incorporate new coping skills into daily life.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Spirituality
Spirituality will be assessed using the 38-item Brief Multidimensional Measure of Religiousness and Spirituality, which assesses spirituality across 11 domains, including: daily spiritual experiences; values and beliefs; forgiveness; private religious practices; religious and spiritual coping; religious support; religious and spiritual history; commitment; organizational religiousness, and overall self ranking.
Measured: baseline, 12 weeks, 24 weeks, and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startFeb 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: No patients have ever been enrolled/consented here at our WF site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Model description
- pilot trial enrolling 26 cancer survivors with chronic chemotherapy-induced peripheral neuropathy (CIPN) who will undergo the painTRAINER intervention
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- HonorHealth Research Institute
- Responsible party
- Sponsor
- Investigators
- Donald B Penzien, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556447
- Sponsor's protocol ID
- IRB00086495
- Other IDs
- 40010561
- Status last verified
- Aug 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Outcomes and Exploration of Mechanisms
- ClinicalTrials.gov ID
- NCT05556447
- Acronym / sponsor ID
- IRB00086495
- Keywords
- paresthesia, dysesthesia, allodynia, hyperalgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients have ever been enrolled/consented here at our WF site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- HonorHealth Research Institute
- Study start
- Feb 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 27 Sep 2022 (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 is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Also proposed is a secondary focus on subjective and objective function, medication use, psychological distress, and coping.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a sensory polyneuropathy occurring in 50-75% of patients receiving neurotoxic chemotherapy that presents with varying degrees of paresthesia, dysesthesia, allodynia, hyperalgesia, and pain. For 30% of survivors, CIPN remains for a lifetime, often accompanied by morbidity, increased healthcare utilization, impaired functional and psychological status, strained relationships, and reduced quality of life. CIPN patients often present with multiple patterns of peripheral neuropathy owing to diversity in their causative etiologies, environmental factors, and patient-specific pathophysiology. Recent studies call for a shift in focus from solely etiologic characterization (e.g. drug mechanism based) to individual pain phenotyping that characterizes CIPN patients based on the reaction of the nervous system (e.g. pain processing). Given its high prevalence, complex presentation, absence of effective prevention, and few established therapies for addressing long-term symptoms, CIPN poses a major burden to patients/providers. Better understanding of CIPN's underlying biological and psychosocial mechanisms paired with enhanced access to effective interventions may lead to improved CIPN management. Cognitive behavioral pain coping skills training (PCST) has shown effectiveness for reducing pain-related suffering among patients with cancer pain as well as those experiencing various neuropathic symptoms-they target specific psychological processes known to contribute to pain, distress, and disability. Despite established effectiveness, in-person PCST interventions often are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, and travel requirements. There remains a need for evidence-based behavioral pain interventions for CIPN delivered with innovative methods to overcome treatment access barriers, reduce pain interference, and enhance quality of life/functioning. We developed an 8-week internet-delivered PCST program using an expert systems approach designed to retain essential features of in-person PCST that does not require therapist involvement-a concept increasingly important for providing socially-distant care amid the corona virus disease (COVID-19) pandemic. The published small trials investigating PCST for CIPN demonstrates promise of this approach for reducing the CIPN burden and justifies larger-scale testing of internet-based PCST for CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot trial enrolling 26 cancer survivors with chronic chemotherapy-induced peripheral neuropathy (CIPN) who will undergo the painTRAINER intervention
| Arm | Type | Receives |
|---|---|---|
| Internet delivered pain coping | Experimental | Behavioral: Internet delivered pain coping skills training8 week online pain coping skills training program with weekly, 45-minute modules guided by an automated coach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must have a documented diagnosis of invasive cancer (of any type) requiring neurotoxic chemotherapy (alone, in combination, or in conjunction with surgery or radiation). Individuals with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
- Must have clinical symptoms of Grade 2 or Grade 3 peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events), AND clinically documented chemotherapy-induced peripheral neuropathy (CIPN) following treatment with any single or combined neurotoxic chemotherapy (i.e., platinums, vinca alkaloids, taxanes, or proteasome inhibitors).
- Must have been ≥24 months since the time in which neurotoxic chemotherapy was first initiated (i.e., time since the first administration of neurotoxic chemotherapy), and either no evidence of residual disease or with stable disease, as established by imaging/clinical exam/laboratory testing.
- Must have completed all planned anticancer therapy (with the exception of maintenance therapy when appropriate). Maintenance therapy includes planned chronic immunotherapy, hormonal therapy, targeted therapy to prevent recurrence of disease rather than to treat active disease. Individuals on maintenance therapy and actively receiving chemotherapy drugs are not eligible. Time frame applies to most recent completion of chemotherapy treatment if participant has experienced cancer recurrence(s).
- Must report a score of ≥ 4 on the single item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (1a) scale.
Key exclusion criteria (9 listed)
- Has a disability or condition that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment; diagnosis or clinical evidence of severe psychiatric disorder; diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
- Reports only preexisting pain conditions deemed unrelated to CIPN (e.g., migraine headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
- Has symptoms of preexisting neuropathy prior to treatment with neurotoxic chemotherapy (i.e., self-reported or documented history of unresolved or pre- existing peripheral neuropathy due to diabetes, HIV, or other conditions known to be unrelated to chemotherapy treatment).
- Has a known or suspected diagnosable substance use disorder (according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria) or is actively receiving treatment for one, per patient report or documented in the medical record.
- Currently being prescribed buprenorphine or suboxone.
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 |
|---|---|---|
| Internet delivered pain coping skills trainingAlso: PCSTParticipants in the intervention group will complete 8 weeks of pain coping skills training delivered online | Behavioural | Internet delivered pain coping |
Primary outcome
Adherence Rate
Time frame: Week 12
Participant adherence in the pilot trial will be measured individually based on the number of modules completed, of the 8 possible modules, during the 12 week intervention period. Participants who complete 6 of the 8 modules will be considered "completers" of the program, though the percent adherence to the program would be 75%.
Retention Rate
Time frame: Week 12
Participant retention in the pilot trial will be based on the percentage of all participants that are retained in the trial overtime. If 100% of participants complete 100% of the modules, this would equate to a 100% retention rate.
Acceptability of the Intervention
Time frame: Week12
Acceptability will be assessed based on two indicators: the ability to recruit the desired number of participants into the trial during the specified recruitment period (26 total participants) and based on assessments of participant satisfaction with the program. Participant satisfaction will be assessed via satisfaction surveys developed specifically for the online pain coping skills training intervention, with questions scored on a likert scale ranging from "not at all satisfied" to "very satisfied" for each unique aspect of the program.
Pain Interference Score
Time frame: baseline
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Pain Interference Score
Time frame: Week 12
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Pain Interference Score
Time frame: Week 24
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Pain Interference Score
Time frame: Week 36
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
8 secondary outcomes
Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Medication and substance amount use
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - PROMIS Cognitive Function scale
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - Patient Health Questionnaire (PHQ 8)
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Coping
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Spirituality
Time frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
Donald B Penzien, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Internet delivered pain coping skills training in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Wake Forest University Health Sciences.
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 11 inclusion and 9 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: withdrawn, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adherence Rate (time frame: Week 12). The study lists 7 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 6 Apr 2025.