Google Location History Following Oesophagectomy and/or Gastrectomy

Quality of Life Clinical Trial

Official title:

Google Location History (GLH) as a Health Tool to Assess Physical Activity Profiles and Patterns Following Oesophagectomy and/or Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035602
• Other study ID #: 20SM6492
• Status: Completed
• Start date: March 24, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Oesophageal Cancer
• Quality of Life
• Survivorship

Intervention

Other:
• Physical activity assessment
Physical activity patterns will be obtained from google location history, using an Android phone

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported physical activity	The self-reported physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ)	Data will be collected at time of study recruitment, up to 5 years after surgery.
Other	Health-related Quality of Life	The Health-related Quality of Life will furthermore be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-OG25 questionnaire.	Data will be collected at time of study recruitment, up to 5 years after surgery.
Other	Health-related Quality of Life	The Health-related Quality of Life will furthermore be reported using the EuroQoL 5 dimensions, 5 level (EQ-5D-5L) questionnaire.	Data will be collected at time of study recruitment, up to 5 years after surgery.
Primary	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	Presence of postoperative morbidity	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.	Thirty-day postoperative morbidity will be collected.
Secondary	Health-related quality of life	The health-related quality of life will be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.	Data will be collected at time of study recruitment, with HRQoL assessed at the time of recruitment (up to 5 years after surgery).