Perioperative Cognitive Training in Thoracic Surgery

Not Applicable

Withdrawn

• Conditions: Cognitive Function Abnormal; Lung Cancer; Pain, Postoperative
• Interventions: Behavioral: COFLEX neurocognitive training; Behavioral: Crossword puzzles

• Registration Number: NCT04563234
• Lead Sponsor: Washington University School of Medicine

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30
• Study Start: 2023-06-30
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COFLEX training	COFLEX neurocognitive training	Neurocognitive training, delivered via a mobile device app
Crossword group	Crossword puzzles	Access to crossword puzzles via a mobile device app

Primary Outcome Measures

Name	Time	Method
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
PROMIS Anxiety Score	3 months after surgery	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
PROMIS Depression score	3 months after surgery	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.
Brief Pain Inventory pain interference	1 and 3 months after surgery	BPI (brief pain inventory) interference score will be compared between the study arms. BPI interference score ranges from 0 (least) to 10 (worst)
Brief Pain Inventory pain severity	1 and 3 months after surgery	BPI (brief pain inventory) severity score will be compared between the study arms. BPI severity score ranges from 0 (least) to 10 (worst)