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Trial not funded.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COFLEX training | Experimental | Neurocognitive training, delivered via a mobile device app |
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| Crossword group | Active Comparator | Access to crossword puzzles via a mobile device app |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COFLEX neurocognitive training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 and 3 months after surgery |
| Brief Pain Inventory pain interference |
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Inclusion Criteria:
Exclusion Criteria:
The inclusion criteria for the observational cohort will be the same, with the exception of Score ā„50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.
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| Name | Affiliation | Role |
|---|---|---|
| Simon Haroutounian, PhD | Washington University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16698416 | Background | 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. | |
| 30586070 | Background | Schug 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. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D003072 | Cognition Disorders |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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All study team members will be blinded to the subject assignment to either intervention (cognitive flexibility training) or control groups (crossword puzzle training), except one coordinator who will monitor participant adherence with the cognitive flexibility training, and send prompts or contact participants to understand barriers to adherence.
|
| Crossword puzzles | Behavioral | 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. |
|
BPI (brief pain inventory) interference score will be compared between the study arms. BPI interference score ranges from 0 (least) to 10 (worst)
| 1 and 3 months after surgery |
| PROMIS Anxiety Score | PROMISĀ® (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 | 3 months after surgery |
| PROMIS Depression score | PROMISĀ® (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. | 3 months after surgery |
| 22395856 | Background | Smith 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |