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Post-Surgery Walking Program for Lung Cancer (AIRTECH Trial)
N/A
Recruiting
Led By Garrett L Walsh
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ambulatory preoperatively
Patients undergoing at least a lobectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after surgery
Awards & highlights
AIRTECH Trial Summary
This trial looks at how walking and sleeping habits affect surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased complications. This information may help researchers develop interventions to improve outcomes after surgery.
Who is the study for?
This trial is for English-speaking adults over 18 with lung cancer who are ambulatory and scheduled for at least a lobectomy. Participants need a smartphone, internet access, and willingness to use a Fitbit app but shouldn't already be using a device to track steps. Excluded are those with conditions affecting study compliance or understanding, inability to wear an activity monitor at consent time, or pregnancy.Check my eligibility
What is being tested?
The AIRTECH Study is testing whether walking after surgery can improve recovery outcomes in lung cancer patients. It involves monitoring walking and sleeping habits through wearable devices like Fitbits and assessing how these activities relate to post-surgical complications and quality of life.See study design
What are the potential side effects?
Since this trial focuses on non-invasive practices such as walking and sleep tracking rather than medication or surgical interventions, traditional side effects aren't applicable. However, participants may experience discomfort from wearing the device.
AIRTECH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was able to walk on my own before surgery.
Select...
I am having surgery to remove a large part of my lung.
Select...
I own a smartphone and agree to install the Fitbit app.
Select...
I am 18 years old or older.
AIRTECH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clavien-Dindo postoperative morbidity (POM) score
Secondary outcome measures
Change in quality of life
Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])
Fitbit user experience (F0 and FB arm)
+4 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
AIRTECH Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (usual care, Fitbit, Fitbit app)Experimental Treatment5 Interventions
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
Group II: Arm I (usual care)Active Control3 Interventions
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.
Group III: Arm II (usual care, Fitbit)Active Control4 Interventions
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,106 Total Patients Enrolled
Garrett L WalshPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was able to walk on my own before surgery.I am having surgery to remove a large part of my lung.You are not currently using a device to track how many steps you take each day.I own a smartphone and agree to install the Fitbit app.I am able to understand and follow the study's requirements.I am 18 years old or older.You are unable to wear the activity monitor at the time you agree to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (usual care, Fitbit, Fitbit app)
- Group 2: Arm I (usual care)
- Group 3: Arm II (usual care, Fitbit)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently being monitored for this clinical experiment?
"Indeed, the information hosted on clinicaltrials.gov confirms that this medical experiment is actively seeking enrollees. Initially posted in November of 2020 and recently updated in September of 2022, 240 patients will be recruited from a single center for participation."
Answered by AI
Are applicants still being considered for this trial?
"As indicated on clinicaltrials.gov, this study is actively seeking patients - the initial post date was November 30th 2020 and the most recent amendment occurred September 22nd 2022."
Answered by AI
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