Perioperative Cognitive Training in Thoracic Surgery

Lung Cancer Clinical Trial

— COFLEX-T  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04563234
• Other study ID #: 202007033
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Function Abnormal
• Lung Cancer
• Pain, Postoperative

Intervention

Behavioral:
• COFLEX neurocognitive training
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 puzzles
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine