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Oesophageal CancerNCT05035602

Google Location History Following Oesophagectomy and/or Gastrectomy

An observational study of Oesophageal Cancer and Gastric Cancer, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Oesophageal Cancer, Gastric Cancer, Survivorship
What is being tested?
Physical activity assessment
How many people
3 participants
Where
1 siteUnited Kingdom
Study dates
24 Mar 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Imperial College London

    London, W2 1NY

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Physical activity assessment
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity assessmentOther

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

Study groups in NCT05035602
Study groupRoleWhat they receive
OesophagectomyPatients who have undergone oesophageal cancer resection.
Receives: Other: Physical activity assessment
GastrectomyPatients who have undergone gastric cancer resection.
Receives: Other: Physical activity assessment
Control groupA cohort consisting of healthy controls who have not been diagnosed with, or have undergone treatment for oesophageal or gastric cancer.
Receives: Other: Physical activity assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity pattern

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

    Measured: 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)
  1. 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.

    Measured: Thirty-day postoperative morbidity will be collected.

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start24 Mar 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035602
Sponsor's protocol ID
20SM6492
Status last verified
Mar 2024
First submitted
21 Apr 2021
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All identifiable data will be anonymised. No data will be shared to other researchers outside the research team for the study.

Publications

  • 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.

    PubMed 30802158
  • 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.

    PubMed 21109491
  • 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.

    PubMed 30625052
  • 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.

    PubMed 21309920
  • 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.

    PubMed 32306081
  • 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.

    PubMed 27508099
  • 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.

    PubMed 26573424
  • 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.

    PubMed 26286199
  • 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.

    PubMed 16688969
  • 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.

    PubMed 31299920
  • 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.

    PubMed 17582628
  • 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.

    PubMed 24697876

Questions about this trial

What is this clinical trial studying?

An observational study of Oesophageal Cancer and Gastric Cancer, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05035602, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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