Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
2 other identifiers
interventional
34
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedMay 15, 2025
May 1, 2025
1.9 years
May 13, 2020
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Through study completion, an average of 2 months
Study Arms (1)
Health Services Research (RT-CAMSS)
EXPERIMENTALPatients 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.
Interventions
Receive tailored feedback, including consultation with nurse
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \< 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuang-Yi Wen, MD
Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
June 29, 2020
Study Start
April 15, 2020
Primary Completion
February 24, 2022
Study Completion
February 24, 2022
Last Updated
May 15, 2025
Record last verified: 2025-05