Pain, PostoperativeCOFLEX-TNCT04563234
Perioperative Cognitive Training in Thoracic Surgery
A study testing COFLEX neurocognitive training and Crossword puzzles in people with Pain, Postoperative and Cognitive Function Abnormal, run by Washington University School of Medicine.
Trial summary
More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative, Cognitive Function Abnormal, Lung Cancer
- What is being tested?
- COFLEX neurocognitive training and Crossword puzzles
- 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
- 30 Jun 2023to 31 Jul 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 to 75 undergoing thoracic surgery
- Access to an active email account
- Score <50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score
Who cannot join
- Unable to complete cognitive testing
- Color blindness assessed via self-report
- Participants who do not speak or read English
- The inclusion criteria for the observational cohort will be the same, with the exception of Score ≥50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.
About this study
Official title: Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery
More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. The proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of PPSP in high-risk individuals undergoing thoracic surgery.
- Being tested
- COFLEX neurocognitive training, Crossword puzzles
- Medical subject headings
- Pain, Postoperative, Cognition Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COFLEX neurocognitive trainingBehavioural
The COFLEX training group will then be provided with the cognitive training module and participants will be required to complete a targeted 30-minute daily training until the day of surgery, and then after the surgery, for a total of 6 weeks.
Crossword puzzlesBehavioural
The control (crossword puzzles) group will be given a training module, where they can access crossword puzzles on the same platform, and can do puzzles whenever they desire over the 6-week time period.
| Study group | Role | What they receive |
|---|---|---|
| COFLEX training | Experimental | Neurocognitive training, delivered via a mobile device app Receives: Behavioral: COFLEX neurocognitive training |
| Crossword group | Active comparator | Access to crossword puzzles via a mobile device app Receives: Behavioral: Crossword puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
Participants will be asked about pain at or around their surgical area (dichotomous yes/no answer), and rate the intensity of pain, if present, on 0-10 numerical rating scale, where 0=no pain, and 10=worst imaginable pain. The presence of PPSP will be compared between the intervention arm and the control arm
Measured: 3 months after surgery
Secondary outcomes (4)
Brief Pain Inventory pain severity
BPI (brief pain inventory) severity score will be compared between the study arms. BPI severity score ranges from 0 (least) to 10 (worst)
Measured: 1 and 3 months after surgery
Brief Pain Inventory pain interference
BPI (brief pain inventory) interference score will be compared between the study arms. BPI interference score ranges from 0 (least) to 10 (worst)
Measured: 1 and 3 months after surgery
PROMIS Anxiety Score
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. 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 7 to 35 with higher scores indicating greater severity of anxiety. The score will be compared between the arms
Measured: 3 months after surgery
PROMIS Depression score
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. 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 7 to 35 with higher scores indicating greater severity of depression. The score will be compared between the arms.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start30 Jun 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Why it stopped: Trial not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Haroutounian, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563234
- Sponsor's protocol ID
- 202007033
- Acronym
- COFLEX-T
- Status last verified
- Jan 2023
- First submitted
- 19 Sep 2020
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
PubMed 30586070Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.
PubMed 22395856
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04563234
- Acronym / sponsor ID
- COFLEX-T / 202007033
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 24 Sep 2020 (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.
More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. The proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of PPSP in high-risk individuals undergoing thoracic surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COFLEX training | Experimental | Behavioral: COFLEX neurocognitive trainingNeurocognitive training, delivered via a mobile device app |
| Crossword group | Active comparator | Behavioral: Crossword puzzlesAccess to crossword puzzles via a mobile device app |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 to 75 undergoing thoracic surgery
- Access to an active email account
- Score <50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score
Key exclusion criteria (4 listed)
- Unable to complete cognitive testing
- Color blindness assessed via self-report
- Participants who do not speak or read English
- The inclusion criteria for the observational cohort will be the same, with the exception of Score ≥50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.
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 |
|---|---|---|
| COFLEX neurocognitive trainingThe COFLEX training group will then be provided with the cognitive training module and participants will be required to complete a targeted 30-minute daily training until the day of surgery, and then after the surgery, for a total of 6 weeks. | Behavioural | COFLEX training |
| Crossword puzzlesThe control (crossword puzzles) group will be given a training module, where they can access crossword puzzles on the same platform, and can do puzzles whenever they desire over the 6-week time period. | Behavioural | Crossword group |
Primary outcome
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
Time frame: 3 months after surgery
Participants will be asked about pain at or around their surgical area (dichotomous yes/no answer), and rate the intensity of pain, if present, on 0-10 numerical rating scale, where 0=no pain, and 10=worst imaginable pain. The presence of PPSP will be compared between the intervention arm and the control arm
4 secondary outcomes
Brief Pain Inventory pain severity
Time frame: 1 and 3 months after surgery
Brief Pain Inventory pain interference
Time frame: 1 and 3 months after surgery
PROMIS Anxiety Score
Time frame: 3 months after surgery
PROMIS Depression score
Time frame: 3 months after surgery
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 30 Jan 2023.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 30586070Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
- Background: PubMed 22395856Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Simon Haroutounian, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing COFLEX neurocognitive training and Crossword puzzles in people with Pain, Postoperative and Cognitive Function Abnormal, run by Washington University School of Medicine.
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 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: withdrawn, as of the sponsor's last update on 30 Jan 2023. 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?
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery (time frame: 3 months after surgery). 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 NCT04563234, which also lists 3 linked publications.
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 30 Jan 2023.