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Completed

NCT Number: NCT04316078

A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.

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Key information

Conditions

Colon Cancer Adenocarcinoma Carcinoma Cholangiocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Small Bowel Cancer Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, 52621, Israel

About this study

Patients will be randomized in a 2:1 ratio.

Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.

A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.

Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
  • Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
  • FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
  • FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
  • FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
  • De Gramont - 5-fluoruracil and leucovorin.
  • Ability to read and comprehend Hebrew language text.
  • Ability to see computer or cell phone screen (i.e., no visual impairment).

Exclusion criteria

  • Eastern Conference Oncology Group (ECOG) performance status greater than 2.
  • Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
  • Inability to read and comprehend Hebrew language text.
  • Current participation in a therapeutic clinical trial.

Treatment and study plan

patient engagement platform

Other
  • Allows patients to receive the action plan as educational videos on demand.
  • Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan.

Primary outcomes

  1. Feasibility of PEP (percent of patients using videos/complete questionnaires)

    Time frame: 3 years

    To assess the feasibility of implementing a PEP in the outpatient gastrointestinal malignancies service, at Sheba Medical Center, for patients undergoing active chemotherapy treatment. This outcome will be measured as percent of patients using the videos and percent of patients that complete the questionnaires.

Secondary outcomes

  1. Secondary clinical outcomes 1 (mean number of referrals)

    Time frame: 3 years

    To monitor mean number of referrals to emergency room and admissions to the inpatient department.

  2. Secondary clinical outcomes 2 (level of chemotoxicity)

    Time frame: 3 years

    To measure level of chemotoxicity - Neuropathy, diarrhea, nausea and vomiting, stomatitis and fever; using total number and percent of patients with side effects in each arm and Common Terminology Criteria for side effects (CTCAE) grading scale.

  3. Secondary clinical outcomes 3 (Quality of Life)

    Time frame: 3 years

    To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).

  4. Secondary clinical outcomes 4 (treatment intensity and continuity)

    Time frame: 3 years

    To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 20, 2020
Registry last updated
Apr 28, 2022

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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