eSyM App Usage for Gastrointestinal Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lifespan, Providence, RI
Gastrointestinal Cancers+4 More
eSyM App Usage - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an electronic symptom tracking system may help improve symptom control for cancer patients.

See full description

Eligible Conditions

  • Gastrointestinal Cancers
  • Gynecologic Cancers
  • Thoracic Cancers
  • Other Cancers

Treatment Effectiveness

Study Objectives

This trial is evaluating whether eSyM App Usage will improve 1 primary outcome and 5 secondary outcomes in patients with Gastrointestinal Cancers. Measurement will happen over the course of 30 days.

1-year medical record abstraction
Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year
Sustainability of ePRO symptom management within a health system
eSyM sustainability at the patient, clinic and health system level
30 days
'Emergency Department - Treat and Release' (EDTR) Rate at 30-days
Day 60
Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage
Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program

Trial Safety

Trial Design

5 Treatment Groups

Activity 2: eSym Build
1 of 5
Activity 1: Stakeholder Feedback
1 of 5
Activity 4: eSyM+ Participants
1 of 5
Activity 3: Pilot Test eSyM App
1 of 5
Activity 4: eSyM- Participants
1 of 5
Active Control
Experimental Treatment

This trial requires 18000 total participants across 5 different treatment groups

This trial involves 5 different treatments. ESyM App Usage is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Activity 4: eSyM+ ParticipantsThese patients (and/or proxy) will report their symptoms in eSyM A subset of these patients will be asked to complete a research questionnaire called the "SASS Questionnaire (eSyM+ version)" A medical record abstraction will be completed for ALL eSyM+ patients
Activity 3: Pilot Test eSyM App
Other
Pilot testing of the eSyM app will include: Activity 3a (eSyM app usage by patients) Activity 3b (User acceptability testing) Activity 3c (Medical record abstraction)
Activity 4: eSyM- Participants
Other
These patients (and/or proxy) will NOT report their symptoms in eSyM A subset of these patients will be asked to complete a research questionnaire called the "SASS Questionnaire (eSyM- version)" A medical record abstraction will be completed for ALL eSyM- patients
Activity 2: eSym BuildBuild and deploy eSyM Finalize training materials based on findings from stakeholder engagement
Activity 1: Stakeholder FeedbackObtain stakeholder feedback to inform eSyM finalization and implementation from: patient advisory councils health system leaders clinicians clinic support staff/administration IT/Informatics

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-year medical record abstraction
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1-year medical record abstraction for reporting.

Who is running the study

Principal Investigator
M. H.
Michael Hassett, Principal Investigator
Dana-Farber Cancer Institute

Closest Location

Lifespan - Providence, RI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who are at least 18 years old. show original
, and other researchers The potential stakeholders for this study are patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff, and other researchers. show original
Suspected lung cancer that is inpatient following thoracic surgery. show original
The person has been admitted to the hospital following surgery for a suspected gynecologic cancer (ovary, uterus, or cervix). show original
The person has been diagnosed with gastrointestinal cancer and is scheduled to start a new treatment plan for the condition. show original
The patient has been diagnosed with gynecologic cancer [ovary, uterus, or cervix] and is scheduled to start a new treatment plan for gynecologic cancer. show original
Patients at any one of the participating sites. show original
who completed the study received all experimental treatments Any patient who completed the study at any participating site received all experimental treatments. show original
The patient has suspected gastrointestinal cancer and is inpatient following gastrointestinal surgery. show original
The person has been diagnosed with thoracic cancer and is scheduled to start a new treatment plan for the condition. show original

Patient Q&A Section

Can gastrointestinal neoplasms be cured?

"The study revealed the absence of cures for certain gastrointestinal neoplasms and confirmed a lack of standardization regarding patient selection and criteria for endoscopic and biologic therapy used in clinical trials: this fact can influence the extrapolation of findings from previous studies. Future studies focused on standardized protocols and randomized controlled trials may improve the scientific basis for the development of new therapeutic modalities for these neoplasms in the future." - Anonymous Online Contributor

Unverified Answer

What are the signs of gastrointestinal neoplasms?

"Signs of gastrointestinal neoplasia last for longer than signs of nonneoplastic conditions of the gastro-intestinal tract. Some of these signs include a palpable mass, diarrhea or constipation, nausea and vomiting, abdominal bloating, and loss of appetite. These signs can be evaluated by endoscopy and computed tomography." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gastrointestinal neoplasms?

"There is no general agreement about what to treat for gastrointestinal neoplasms. Some doctors use surgery, while others recommend medical treatment, radiation therapy, or a combination of the above. For gastrointestinal cancer, chemotherapy is recommended by some doctors, while others disagree." - Anonymous Online Contributor

Unverified Answer

How many people get gastrointestinal neoplasms a year in the United States?

"Gastrointestinal neoplasms are relatively more common in the US compared to other developed areas of the world. However, this increase in incidence has not been associated with any increase in mortality or morbidity." - Anonymous Online Contributor

Unverified Answer

What causes gastrointestinal neoplasms?

"Many gastrointestinal neoplasms may be caused by genetic factors present in the person before the development of the neoplasm. However, many cancer cases are due to environmental factors or lifestyle choices. Patients with a positive family history or history of other gastrointestinal malignancies should be evaluated to rule out a hereditary component. Tobacco and alcohol consumption are significant risk factors in acquiring gastric cancer. Lymphoma often has an immunosuppressive cause. Some cancers are associated with certain medications that can cause or accelerate the cancer. Medications that cause bone marrow disorders and a reduction in the number of lymphocytes are considered to be a possible trigger for these cancers." - Anonymous Online Contributor

Unverified Answer

What is gastrointestinal neoplasms?

"Gastrointestinal neoplasm refers to cancers that arise from the epithelium lining in the stomach, intestines, gallbladder or other parts of the digestive system. Most gastrointestinal neoplasms that occur in people in Western countries are due to smoking, alcohol consumption and/or aging. The most common types of gastrointestinal neoplasms that occur in persons in Western countries are\ncolorectal cancer, stomach cancer, hepatocellular cancer, pancreatic cancer, and colon cancer while in Eastern\ncountries the most common are cholangiocarcinoma, biliary tract cancer, intestinal cancer,\nstomach cancer, and pancreatic cancer." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of gastrointestinal neoplasms?

"A strong genetic and environmental risk factor (cancer predisposition) is important. The most important cancers in this study were gastric and colorectal carcinomas. Gastric carcinomas are of the diffuse type and were likely to occur in subjects with a hereditary pattern of cancer predisposition." - Anonymous Online Contributor

Unverified Answer

How serious can gastrointestinal neoplasms be?

"Even with the same location and stage, there are significant differences in survival between patients with different types of gastrointestinal neoplasms. Patients with adenocarcinoma derive the most benefit from treatments that have been proven to be useful in other cancers." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating gastrointestinal neoplasms?

"The only treatments that are known to worsen progression-free survival are [imatinib] and [cetuximab]. There are many therapies [e.g., chemotherapy] that can improve progression-free survival. Trials are warranted to find treatments that have little to no risk of increasing progression-free survival and that have a lower risk of worsening outcome." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for gastrointestinal neoplasms?

"Patients' willingness depends on multiple factors; a significant proportion of patients were not yet familiar with clinical trials, especially those who are on regular medications. They do not have adequate information by a questionnaire on the clinical trials at the time of consultation. The most appropriate clinical trials to evaluate the treatment of gastrointestinal neoplasms were gastro oncology trials." - Anonymous Online Contributor

Unverified Answer

Does gastrointestinal neoplasms run in families?

"Although our data are based on a relatively small number of cases, it appears that genetic testing of gastrointestinal neoplasms may be feasible and beneficial for identifying patients who may develop GI neoplasms." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets gastrointestinal neoplasms?

"The mean age of neoplasms and benign lesions is 56 years old. Gastrointestinal neoplasms are the most frequent gastrointestinal malignancy diagnosed in children (<15 years old). Adenoid adenoma is the most frequent benign gastrointestinal tumor in children (<15 years old)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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