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OpenTrials
Completed

NCT Number: NCT05035602

Google Location History 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Activity Assessment

Other

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

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Presence of postoperative morbidity

    Time frame: Thirty-day postoperative morbidity will be collected.

    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.

  2. 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).

    The health-related quality of life will be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.

Other outcomes

  1. Self-reported physical activity

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

    The self-reported physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ)

  2. Health-related Quality of Life

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

    The Health-related Quality of Life will furthermore be reported using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-OG25 questionnaire.

  3. Health-related Quality of Life

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

    The Health-related Quality of Life will furthermore be reported using the EuroQoL 5 dimensions, 5 level (EQ-5D-5L) questionnaire.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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