Google Location History Following Oesophagectomy and/or Gastrectomy

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05035602
Collaborator
(none)
300
1
8.3
36.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical activity assessment

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Google Location History (GLH) as a Health Tool to Assess Physical Activity Profiles and Patterns Following Oesophagectomy and/or Gastrectomy
Actual Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Oesophagectomy

Patients who have undergone oesophageal cancer resection.

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

Gastrectomy

Patients who have undergone gastric cancer resection.

Other: Physical activity assessment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in physical activity pattern [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 Outcome Measures

  1. Presence of postoperative morbidity [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 [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 Outcome Measures

  1. Self-reported physical activity [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom W2 1NY

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05035602
Other Study ID Numbers:
  • 20SM6492
First Posted:
Sep 5, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 31, 2022