Google Location History Following Oesophagectomy and/or Gastrectomy

NCT ID: NCT05035602

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2023-12-31

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.

Detailed Description

Surgery is the mainstay of treatment for patients diagnosed 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. Several studies have shown that low physical activity levels are associated with increased risk for respiratory complication. Furthermore, patients with oesophageal or gastric cancer often 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. Moreover, open oesophagectomy involves thoracotomy, thus impairing respiratory mechanics with further deterioration in physical fitness. 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. Enhanced recovery programmes are evidence-based protocols aiming at early recovery after surgery with early mobilisation and physiotherapy, and have been shown to reduce respiratory complication rates. Thus, quantifying physical activity levels in these patients may identify the period in which patients' activity levels are most likely to deteriorate and whether these changes in physical activity are associated with changes in quality of life. Activity levels will be assessed from Google Location History from the patient's phone, providing summary of patterns 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Oesophagectomy

Patients who have undergone oesophageal cancer resection.

Physical activity assessment

Intervention Type: OTHER

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

Gastrectomy

Patients who have undergone gastric cancer resection.

Physical activity assessment

Intervention Type: OTHER

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

Control group

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

Physical activity assessment

Intervention Type: OTHER

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

Interventions

Physical activity assessment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College London

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 30802158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21109491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30625052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21309920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32306081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27508099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26573424 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26286199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16688969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31299920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17582628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24697876 (View on PubMed)

Other Identifiers

20SM6492

Identifier Type: -

Identifier Source: org_study_id