Back to resultsPerioperative Cognitive Training in Thoracic Surgery (COFLEX-T)
Primary Purpose
Pain, Postoperative, Cognitive Function Abnormal, Lung Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COFLEX neurocognitive training
Crossword puzzles
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COFLEX training
Crossword group
Arm Description
Neurocognitive training, delivered via a mobile device app
Access to crossword puzzles via a mobile device app
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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
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.
Full Information
NCT ID
NCT04563234
First Posted
September 19, 2020
Last Updated
January 26, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04563234
Brief Title
Perioperative Cognitive Training in Thoracic Surgery
Acronym
COFLEX-T
Official Title
Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Trial not funded.
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Cognitive Function Abnormal, Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COFLEX training
Arm Type
Experimental
Arm Description
Neurocognitive training, delivered via a mobile device app
Arm Title
Crossword group
Arm Type
Active Comparator
Arm Description
Access to crossword puzzles via a mobile device app
Intervention Type
Behavioral
Intervention Name(s)
COFLEX neurocognitive training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Crossword puzzles
Intervention Description
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.
Primary Outcome Measure Information:
Title
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
Description
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
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Brief Pain Inventory pain severity
Description
BPI (brief pain inventory) severity score will be compared between the study arms. BPI severity score ranges from 0 (least) to 10 (worst)
Time Frame
1 and 3 months after surgery
Title
Brief Pain Inventory pain interference
Description
BPI (brief pain inventory) interference score will be compared between the study arms. BPI interference score ranges from 0 (least) to 10 (worst)
Time Frame
1 and 3 months after surgery
Title
PROMIS Anxiety Score
Description
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
Time Frame
3 months after surgery
Title
PROMIS Depression score
Description
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.
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16698416
Citation
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.
Results Reference
background
PubMed Identifier
30586070
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.
Results Reference
background
PubMed Identifier
22395856
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.
Results Reference
background
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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Perioperative Cognitive Training in Thoracic Surgery
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