- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05035602
Google Location History Following Oesophagectomy and/or Gastrectomy
Google Location History (GLH) as a Health Tool to Assess Physical Activity Profiles and Patterns Following Oesophagectomy and/or Gastrectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, W2 1NY
- Imperial College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
There will be three cohorts, consisting of post-oesophagectomy patients, post-gastrectomy patients and a third group consisting of healthy controls.
The participants will be eligible if aged 18 years or older, up to 90 years of age.
Participants will be eligible if they can provide informed consent and can walk, run or cycle a short distance, and if they are using an Android phone.
Description
Inclusion Criteria post-oesophagectomy or -gastrectomy group:
- is 18 years or older, and below 90 years of age, AND
- be able to walk, run or cycle a short distance, AND
- has been diagnosed with or already treated for oesophageal or gastric cancer
- if already receiving treatment, any type of treatment is included, either surgical resection for early-stage disease or definitive chemotherapy for advanced disease, AND
- use and Android phone
Inclusion Criteria healthy controls:
- is 18 years or older, and below 90 years of age, AND
- no previous history of upper gastrointestinal cancer, AND
- not diagnosed with or undergoing treatment for active cancer since active cancer or cancer-related treatment might influence physical activity levels and quality of life, AND
- be able to walk, run or cycle a short distance, AND
- use an Android phone
Exclusion Criteria:
- lacks capacity or is unable to provide informed consent, OR
- below 18 years of age or over 90 years of age, OR
- cannot walk, run or cycle a short distance, OR
- is diagnosed with or undergoing treatment for active cancer other than oesophageal or gastric cancer, OR
- is pregnant, OR
- is not using an Android phone, as Google Location History data is only accessible from an Android device
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Oesophagectomy
Patients who have undergone oesophageal cancer resection.
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Physical activity patterns will be obtained from google location history, using an Android phone
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Gastrectomy
Patients who have undergone gastric cancer resection.
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Physical activity patterns will be obtained from google location history, using an Android phone
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Control group
A cohort consisting of healthy controls who have not been diagnosed with, or have undergone treatment for oesophageal or gastric cancer.
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Physical activity patterns will be obtained from google location history, using an Android phone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in physical activity pattern
Time Frame: Data will be collected up to 5 years prior to oesophageal or gastric cancer diagnosis and up to 5 years after oesophagectomy and/or gastrectomy.
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The physical activity pattern will be grouped into light vs moderate vigorous activity
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Data will be collected up to 5 years prior to oesophageal or gastric cancer diagnosis and up to 5 years after oesophagectomy and/or gastrectomy.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence of postoperative morbidity
Time Frame: Thirty-day postoperative morbidity will be collected.
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All types of postoperative morbidity will be assessed, including postoperative pulmonary complications, neurological damage, gastrointestinal symptoms, sepsis, anastomotic leak, cardiac or renal complications, urological complications, wound infection.
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Thirty-day postoperative morbidity will be collected.
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Health-related quality of life
Time Frame: Data will be collected at time of study recruitment, with HRQoL assessed at the time of recruitment (up to 5 years after surgery).
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The health-related quality of life will be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
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Data will be collected at time of study recruitment, with HRQoL assessed at the time of recruitment (up to 5 years after surgery).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported physical activity
Time Frame: Data will be collected at time of study recruitment, up to 5 years after surgery.
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The self-reported physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ)
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Data will be collected at time of study recruitment, up to 5 years after surgery.
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Health-related Quality of Life
Time Frame: Data will be collected at time of study recruitment, up to 5 years after surgery.
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The Health-related Quality of Life will furthermore be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-OG25 questionnaire.
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Data will be collected at time of study recruitment, up to 5 years after surgery.
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Health-related Quality of Life
Time Frame: Data will be collected at time of study recruitment, up to 5 years after surgery.
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The Health-related Quality of Life will furthermore be reported using the EuroQoL 5 dimensions, 5 level (EQ-5D-5L) questionnaire.
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Data will be collected at time of study recruitment, up to 5 years after surgery.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Anandavadivelan P, Lagergren P. Cachexia in patients with oesophageal cancer. Nat Rev Clin Oncol. 2016 Mar;13(3):185-98. doi: 10.1038/nrclinonc.2015.200. Epub 2015 Nov 17.
- Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Maeda S, Haraguchi N, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Prevalence of Malnutrition Among Gastric Cancer Patients Undergoing Gastrectomy and Optimal Preoperative Nutritional Support for Preventing Surgical Site Infections. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S778-85. doi: 10.1245/s10434-015-4820-9. Epub 2015 Aug 19.
- Costas-Chavarri A, Nandakumar G, Temin S, Lopes G, Cervantes A, Cruz Correa M, Engineer R, Hamashima C, Ho GF, Huitzil FD, Malekzadeh Moghani M, Sharara AI, Stern MC, Teh C, Vazquez Manjarrez SE, Verjee A, Yantiss R, Shah MA. Treatment of Patients With Early-Stage Colorectal Cancer: ASCO Resource-Stratified Guideline. J Glob Oncol. 2019 Feb;5:1-19. doi: 10.1200/JGO.18.00214.
- Mariette C, Piessen G, Briez N, Gronnier C, Triboulet JP. Oesophagogastric junction adenocarcinoma: which therapeutic approach? Lancet Oncol. 2011 Mar;12(3):296-305. doi: 10.1016/S1470-2045(10)70125-X. Epub 2010 Nov 23.
- Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.
- Feeney C, Reynolds JV, Hussey J. Preoperative physical activity levels and postoperative pulmonary complications post-esophagectomy. Dis Esophagus. 2011 Sep;24(7):489-94. doi: 10.1111/j.1442-2050.2010.01171.x. Epub 2011 Feb 10.
- Toriumi T, Yamashita H, Kawasaki K, Okumura Y, Wakamatsu K, Yagi K, Aikou S, Nomura S, Seto Y. Preoperative Exercise Habits are Associated with Post-gastrectomy Complications. World J Surg. 2020 Aug;44(8):2736-2742. doi: 10.1007/s00268-020-05493-3.
- Wang L, Wang C, Guan S, Cheng Y. Impacts of physically active and under-active on clinical outcomes of esophageal cancer patients undergoing esophagectomy. Am J Cancer Res. 2016 Jul 1;6(7):1572-81. eCollection 2016.
- Stewart GD, Skipworth RJ, Fearon KC. Cancer cachexia and fatigue. Clin Med (Lond). 2006 Mar-Apr;6(2):140-3. doi: 10.7861/clinmedicine.6-2-140. No abstract available.
- Guinan EM, Bennett AE, Doyle SL, O'Neill L, Gannon J, Foley G, Elliott JA, O'Sullivan J, Reynolds JV, Hussey J. Measuring the impact of oesophagectomy on physical functioning and physical activity participation: a prospective study. BMC Cancer. 2019 Jul 12;19(1):682. doi: 10.1186/s12885-019-5888-6.
- Lagergren P, Avery KN, Hughes R, Barham CP, Alderson D, Falk SJ, Blazeby JM. Health-related quality of life among patients cured by surgery for esophageal cancer. Cancer. 2007 Aug 1;110(3):686-93. doi: 10.1002/cncr.22833.
- Markar SR, Karthikesalingam A, Low DE. Enhanced recovery pathways lead to an improvement in postoperative outcomes following esophagectomy: systematic review and pooled analysis. Dis Esophagus. 2015 Jul;28(5):468-75. doi: 10.1111/dote.12214. Epub 2014 Apr 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20SM6492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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