Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
Study Details
Study Description
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.
Detailed Description
PRIMARY OBJECTIVES:
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Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) and mobile platforms for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
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Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
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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
PRIMARY OBJECTIVES:
-
Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) and mobile platforms for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
-
Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
-
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Health Services Research (RT-CAMSS) 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. |
Other: Patient Monitoring System
Receive RT-CAMSS
Other: Questionnaire Administration
Complete questionnaires
Other: Consultation
Receive tailored feedback, including consultation with nurse
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Feasibility of the Real-Time Chemo-Associated side effects Monitoring Support System (RT-CAMSS) [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be measured through study accrual, attrition, and system usage frequencies. The intervention will be considered feasible if attrition does not exceed 30%.
- Engagement of the RT-CAMSS [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be measured through study accrual, attrition, and system usage frequencies. The intervention will be considered feasible if attrition does not exceed 30%.
- Acceptability of the RT-CAMSS [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.
- Quality of life [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be assessed by the Functional Assessment of Cancer Treatment - General scale questionnaire.
- Symptom distress [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be assessed by The Memorial Symptom Assessment Scale.
- Self-efficacy [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be assessed using the Patient Activation Measure for assessing skills, knowledge and self-confidence for self-management.
- Information and support needs [Prior to start of chemotherapy treatment]
Will be assessed using the Cancer Treatment Scale.
- Comorbidities [Up to 2 months or until chemotherapy is discontinued, whichever is earlier]
Will be assessed with the Charlson Co-Morbidity Index.
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer (no limitation on stage)
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Scheduled to start chemotherapy (i.e., leucovorin plus fluorouracil and oxaliplatin [FOLFOX]); fluorouracil (5-FU) plus leucovorin, oxaliplatin and docetaxel (FLOT); 5-FU plus leucovorin, irinotecan and oxaliplatin or standard single-drug treatment plus gemcitabine (FOLFIRINOX); taxol/carboplatin plus radiotherapy) before surgery
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Able to read and understand English
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Able to provide signed and dated informed consent form
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Have a mobile device with TXT capability
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Know or willing to learn how to use TXT
Exclusion Criteria:
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• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
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Have symptoms from cancer itself, other diseases, or surgeries that physicians don't think appropriate for this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Thomas Jefferson University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kuang-Yi Wen, MD, Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20G.090