Google Location History Following Oesophagectomy and/or Gastrectomy

NCT05035602 | Completed DMC

• 1 other identifier: 20SM6492
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery is the mainstay of treatment for patients with early-disease esophageal and gastric cancer. Open surgery for oesophageal cancer commonly involves large incisions in the chest, which is associated with a high rate of respiratory complications in the postoperative period. Patients with oesophageal or gastric cancer furthermore commonly present with significant weight loss, affecting both muscle mass and muscle strength. This could further decrease the physical fitness and increase the risk for experiencing complications after treatment. Patients also report a decreased physical functioning in quality of life at least 3 years after surgery, suggesting this is a persistent deficit. Currently, no long-term data is available assessing physical activity levels in oesophageal or gastric cancer survivors. Thus, quantifying physical activity levels in these patients may identify the period in which patients' activity levels are most likely to deteriorate. Activity levels will be assessed from Google Location History from the patient's phone, providing summary of physical activity over time. This information could be used in the future to provide adequate physical therapy intervention which might improve recovery in several aspects, such as physical fitness but also respiratory function and quality of life.

Conditions

Oesophageal Cancer; Gastric Cancer; Survivorship; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in physical activity pattern

  The physical activity pattern will be grouped into light vs moderate vigorous activity

  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.

Secondary Outcomes (2)

• Presence of postoperative morbidity

  Thirty-day postoperative morbidity will be collected.

• Health-related quality of life

  Data will be collected at time of study recruitment, with HRQoL assessed at the time of recruitment (up to 5 years after surgery).

Other Outcomes (3)

• Self-reported physical activity

  Data will be collected at time of study recruitment, up to 5 years after surgery.

• Health-related Quality of Life

  Data will be collected at time of study recruitment, up to 5 years after surgery.

• Health-related Quality of Life

  Data will be collected at time of study recruitment, up to 5 years after surgery.

Study Arms (3)

Oesophagectomy

Patients who have undergone oesophageal cancer resection.

Other: Physical activity assessment

Gastrectomy

Patients who have undergone gastric cancer resection.

Other: Physical activity assessment

Control group

A cohort consisting of healthy controls who have not been diagnosed with, or have undergone treatment for oesophageal or gastric cancer.

Other: Physical activity assessment

Interventions

Physical activity assessment OTHER

Physical activity patterns will be obtained from google location history, using an Android phone

Control group; Gastrectomy; Oesophagectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 30802158 BACKGROUND

• 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.

  PMID: 21109491 BACKGROUND

• 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.

  PMID: 30625052 BACKGROUND

• 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.

  PMID: 21309920 BACKGROUND

• 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.

  PMID: 32306081 BACKGROUND

• 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.

  PMID: 27508099 BACKGROUND

• 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.

  PMID: 26573424 BACKGROUND

• 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.

  PMID: 26286199 BACKGROUND

• 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.

  PMID: 16688969 BACKGROUND

• 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.

  PMID: 31299920 BACKGROUND

• 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.

  PMID: 17582628 BACKGROUND

• 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.

  PMID: 24697876 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: September 5, 2021
• Study Start: March 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)