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Completed

NCT Number: NCT04449679

Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study

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.

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Key information

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 Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage II Gastric Cancer AJCC v8 Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8 Clinical Stage IIA Gastric Cancer AJCC v8 Clinical Stage IIB Gastric Cancer AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IVA Gastric Cancer AJCC v8 Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8 Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IVB Gastric Cancer AJCC v8 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8 Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage 0 Gastric Cancer AJCC v8 Pathologic Stage I Esophageal Adenocarcinoma AJCC v8 Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage I Gastric Cancer AJCC v8 Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IA Gastric Cancer AJCC v8 Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IB Gastric Cancer AJCC v8 Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8 Pathologic Stage II Esophageal Adenocarcinoma AJCC v8 Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage II Gastric Cancer AJCC v8 Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IIA Gastric Cancer AJCC v8 Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IIB Gastric Cancer AJCC v8 Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage III Gastric Cancer AJCC v8 Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IIIA Gastric Cancer AJCC v8 Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IIIB Gastric Cancer AJCC v8 Pathologic Stage IIIC Gastric Cancer AJCC v8 Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IV Gastric Cancer AJCC v8 Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8 Rectal Diseases Stage 0 Colorectal Cancer AJCC v8 Stage 0 Pancreatic Cancer AJCC v8 Stage I Colorectal Cancer AJCC v8 Stage I Pancreatic Cancer AJCC v8 Stage IA Pancreatic Cancer AJCC v8 Stage IB Pancreatic Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage II Pancreatic Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Colorectal Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage IIC Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

PRIMARY OBJECTIVES:

I. 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • < 18 years of age
  • Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)

Treatment and study plan

Patient Monitoring System

Other

Receive RT-CAMSS

Questionnaire Administration

Other

Complete questionnaires

consultation

Other

Receive tailored feedback, including consultation with nurse

Other names: Consult

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Medical information

    Time frame: Baseline

    Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2020
Registry last updated
May 15, 2025

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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