Perioperative Cognitive Training in Thoracic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery

Conditions
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Pain, Postoperative, Cognitive Function Abnormal, Lung Cancer

Intervention / Treatment
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* Behavioral: COFLEX neurocognitive training
* Behavioral: Crossword puzzles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COFLEX training<br>Neurocognitive training, delivered via a mobile device app | Behavioral: COFLEX neurocognitive training<br>* 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.<br>|
| Active Comparator: Crossword group<br>Access to crossword puzzles via a mobile device app | Behavioral: Crossword puzzles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 | 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. | 3 months after surgery |