Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8NCT04449679
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
A study testing Patient Monitoring System, Questionnaire Administration and Consultation in people with Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 and Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8
- What is being tested?
- Patient Monitoring System, Questionnaire Administration and Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 24 Feb 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
- Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
- Able to read and understand English
- Able to provide signed and dated informed consent form
- Have a mobile device with text message capability
- Know or willing to learn how to use text messaging
Who cannot join
- < 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress.
OUTLINE:
PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios.
PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse.
After completion of study, patients are followed up at 1 and 2 months.
- Conditions
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
- Being tested
- Patient Monitoring System, Questionnaire Administration, Consultation
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Monitoring SystemOther
Receive RT-CAMSS
Questionnaire AdministrationOther
Complete questionnaires
ConsultationOther
Also called Consult
Receive tailored feedback, including consultation with nurse
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (RT-CAMSS) | Experimental | Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse. Receives: Other: Patient Monitoring System; Other: Questionnaire Administration; Other: Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Engagement
Will be measured through study accrual, attrition, and system usage frequencies. We aim for accrual at a rate of 50% to match our prior study but a rate over 30% will be feasible. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participants reporting their symptoms at least once will be considered adequate.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Acceptability
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score >= 3 on the 1-4 satisfaction scale.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Symptom distress
The Memorial Symptom Assessment Scale (MSAS), a well-validated instrument that will be used to assess common physical symptoms concerning chemotherapy in patients. The MSAS measures the prevalence, frequency, severity, and distress of 25 physical symptoms and seven psychological symptoms.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Self-efficacy
Will be measured using the Patient Activation Measure (PAM) for assessing skills, knowledge and self-confidence for self-management. The scale asks participants concerning their certainty of controlling symptoms caused by chemotherapy to perform daily activities.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Information and support needs
Will be measured using the Cancer Treatment Scale (CaTS). The CaTS assesses patient's preparation prior to the start of their chemotherapy treatment.
Measured: Prior to start of chemotherapy treatment
Medical information
Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Measured: Baseline
Functional Assessment of Cancer Treatment - General scale
Questionnaire will be used to assess patient quality of life. The 27-item FACT-G assesses four specific domains including physical, social, emotional and functional well-being.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Social support
The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support.
Measured: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Post-intervention evaluation
Patient interviews will explore key domains including perceived usefulness, how well the enhanced usual care and the RT-CAMSS address their concerns, whether there are additional issues they would like to see included and the characteristics of the text message.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start15 Apr 2020
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios. PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Yi Wen, MD, Principal investigator, Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449679
- Sponsor's protocol ID
- 20G.090
- Other IDs
- JT 15039
- Status last verified
- May 2025
- First submitted
- 13 May 2020
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
- ClinicalTrials.gov ID
- NCT04449679
- Acronym / sponsor ID
- 20G.090
- Conditions
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress.
OUTLINE:
PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios.
PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse.
After completion of study, patients are followed up at 1 and 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios. PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse.
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (RT-CAMSS) | Experimental | Other: Patient Monitoring System, Other: Questionnaire Administration, Other: ConsultationPatients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
- Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
- Able to read and understand English
- Able to provide signed and dated informed consent form
- Have a mobile device with text message capability
Key exclusion criteria (2 listed)
- < 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Monitoring SystemReceive RT-CAMSS | Other | Health Services Research (RT-CAMSS) |
| Questionnaire AdministrationComplete questionnaires | Other | Health Services Research (RT-CAMSS) |
| ConsultationAlso: ConsultReceive tailored feedback, including consultation with nurse | Other | Health Services Research (RT-CAMSS) |
Primary outcome
Feasibility and Engagement
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through study accrual, attrition, and system usage frequencies. We aim for accrual at a rate of 50% to match our prior study but a rate over 30% will be feasible. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participants reporting their symptoms at least once will be considered adequate.
Acceptability
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score >= 3 on the 1-4 satisfaction scale.
Symptom distress
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Memorial Symptom Assessment Scale (MSAS), a well-validated instrument that will be used to assess common physical symptoms concerning chemotherapy in patients. The MSAS measures the prevalence, frequency, severity, and distress of 25 physical symptoms and seven psychological symptoms.
Self-efficacy
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured using the Patient Activation Measure (PAM) for assessing skills, knowledge and self-confidence for self-management. The scale asks participants concerning their certainty of controlling symptoms caused by chemotherapy to perform daily activities.
Information and support needs
Time frame: Prior to start of chemotherapy treatment
Will be measured using the Cancer Treatment Scale (CaTS). The CaTS assesses patient's preparation prior to the start of their chemotherapy treatment.
Medical information
Time frame: Baseline
Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Functional Assessment of Cancer Treatment - General scale
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Questionnaire will be used to assess patient quality of life. The 27-item FACT-G assesses four specific domains including physical, social, emotional and functional well-being.
Social support
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support.
Post-intervention evaluation
Time frame: Through study completion, an average of 2 months
Patient interviews will explore key domains including perceived usefulness, how well the enhanced usual care and the RT-CAMSS address their concerns, whether there are additional issues they would like to see included and the characteristics of the text message.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuang-Yi Wen, MD principal investigator
Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Monitoring System, Questionnaire Administration and Consultation in people with Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 and Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, run by Thomas Jefferson University at 1 site in United States.
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 6 inclusion and 2 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 15 May 2025. 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 States. 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?
Feasibility and Engagement (time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.