Cognitive Function Abnormal, Lung Cancer, Pain, Postoperative
Conditions
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.
Interventions
BEHAVIORALCOFLEX 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.
BEHAVIORALCrossword 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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. |
Outcome results
None listed