Perioperative Cognitive Training in Thoracic Surgery

NCT04563234 | Withdrawn

• 1 other identifier: 202007033
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Cognitive Function Abnormal; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Brief Pain Inventory pain severity

  1 and 3 months after surgery

• Brief Pain Inventory pain interference

  1 and 3 months after surgery

• PROMIS Anxiety Score

  3 months after surgery

• PROMIS Depression score

  3 months after surgery

Study Arms (2)

COFLEX training

EXPERIMENTAL

Neurocognitive training, delivered via a mobile device app

Behavioral: COFLEX neurocognitive training

Crossword group

ACTIVE COMPARATOR

Access to crossword puzzles via a mobile device app

Behavioral: Crossword puzzles

Interventions

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.

COFLEX training

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.

Crossword group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to complete cognitive testing
• Color blindness assessed via self-report
• Participants who do not speak or read English

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related 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.

  PMID: 16698416 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.

  PMID: 30586070 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.

  PMID: 22395856 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative; Cognition Disorders; Lung Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Simon Haroutounian, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 24, 2020
• Study Start: June 30, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share