Diminish Chemotherapy Related Side Effects Through Patient Education (D-CRSE)

D-CRSE: Diminish Chemotherapy Related Side Effects Through Patient Education in Patients With Breast OR Gastrointestinal Cancer Who Are Undergoing Cytotoxic Chemotherapy

Currently, there is a lack of patient education materials regarding cytotoxic chemotherapy side effects, research supported treatments, and the utilization of CAM by cancer patients at Penn State Cancer Institute. The investigators aim to develop an educational brochure, which educates patients about the chemotherapy side effects they may experience, and provide them with the tools to address the problem themselves, know when to contact their medical oncologist, and understand when it is appropriate to go to the Emergency Department. By educating patients regarding these problems, patient anxiety may decrease, the number of calls into the oncologist office may decrease, and Emergency Department visits may decrease, which would decrease costs for the patient, the hospital, and the health system. If this intervention is found to be useful and impactful, it can be further utilized within the Cancer Institute by other disease teams, by other Penn State institutions, or by other institutions across the country.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect; Chemotherapeutic Toxicity; Chemotherapeutic Agent Toxicity
• Intervention / Treatment: Other: Educational Brochure

Detailed Description

The diagnosis of cancer is a life-altering event which can cause a large amount of distress in patients. One of the several factors that impacts a patient's level of distress, is their fear of the diagnosis and their lack of information in the beginning their cancer journey. Understandably, many patients turn to easily accessible but disreputable resources, such as the internet, to learn and mentally prepare themselves for this journey. Friends and family members may also provide advice or recommendations which may not always be scientifically supported. Disreputable resources often have incorrect information that can scare or mislead a patient, which can severely impact their health and fight against cancer. In order to help patients fight these fears and become properly equipped for the cancer journey, care teams must address the education of patients, especially the education about the chemotherapy treatment process and potential side effects.

The primary purpose of this pilot study is to determine the utility of a brochure to educate breast and gastrointestinal cancer patients undergoing cytotoxic chemotherapy about the side effects of treatment, in addition to providing them with tools and recommendations to lessen the impact of these side effects on their quality of life. A questionnaire-based approach and the Patient Education Material Assessment Tool (PEMAT) will be employed to evaluate participant's responses in a variety of domains, such as understandability, actionability, and utility of the brochure. The Memorial Symptom Assessment Scale (MSAS) will be used to capture the specific chemotherapy side effects that each patient is experiencing throughout their treatment. Emotional Thermometer Scales (ETS) will be utilized to assess patients' feelings of depression, anxiety, anger, and distress at the beginning and end of their treatment. Survey questions will be utilized at interval time points (baseline plus 6 and 12 weeks) to evaluate the overall impact of the brochure on their quality of life and symptom management. All patients will receive the brochure and fill out the associated assessment scales and tools. The investigator's hypothesis is that a brochure providing information and tools to address the side effects of breast and gastrointestinal cancer cytotoxic chemotherapy will have utility in cancer clinics and allow patients to improve their quality of life by following the scientifically supported recommendations within the brochure.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with a diagnosis of breast or gastrointestinal cancer, at any stage or progression, who are cytotoxic chemotherapy treatment naïve and initiating treatment or have newly begun cytotoxic chemotherapy within the last 6 weeks. Patients receiving multiple therapy forms, such as immune or humoral, can be included if they are also receiving cytotoxic chemotherapy as a part of their regimen. All patients will receive the brochure, therefore, there will not be a control arm in this study.

  1. Adult >20 year of age
  2. Ability to understand and read written English without any functional difficulty
  3. ECOG performance status 0-3
  4. May be involved with other cancer trials being offered at the Penn State Cancer Institute

Exclusion Criteria

1. Inability to give informed consent
2. Pregnant females
3. Inability to understand or read written English
4. Patients who have previously undergone cytotoxic chemotherapy at any point in their lifetime or began chemotherapy for their breast or gastrointestinal cancer greater than 6 weeks from the initiation of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Single arm, interventional. All participants will be administered Educational Brochure to educate them regarding management of side effects experienced during chemotherapy treatment	Other: Educational Brochure; Participants will be provided with Education Brochure developed by the study team to provide information to patients about managing side effects related to chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of Educational Brochure assessment	• Assessment of the utility of a brochure which educates breast and gastrointestinal cancer patients about the potential side effects of cytotoxic chemotherapy, as measured by the validated PEMAT survey score mean and standard deviation from baseline compared to 6 and 12 weeks post baseline assessment. The Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P) scale used for above outcome ranges from minimum of score 0 percent to maximum score of 100 percent. Higher values indicate better outcome.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Assessment	• Assessment of participant symptoms during cytotoxic chemotherapy treatment utilizing the MSAS. Memorial Symptom Assessment Scale used for above outcome ranges from minimum of score 0 to maximum score of 364. Higher values indicate presence of more and severe symptoms thus indicating worse outcome.	12 weeks
Emotional Assessment	• Assessment of participant emotions at the beginning and end of the study by comparing ETS scores. The Emotional Thermometer Scale used for above outcome ranges from minimum of score 0 to maximum score of 50. Higher values indicate presence of more and severe symptoms thus indicating worse outcome.	12 weeks
Baseline Educational Assessment	• Identification of participants with immediate family member (child, spouse, parent) who underwent cytotoxic chemotherapy and participant's education level through questionnaire.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Assessment	• Measure of participant withdraw rate from study as a representation of feasibility.	12 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Monali Vasekar, MD, Penn State Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): March 19, 2023
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PSCI-19-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information will be collected in De identified manner . IPD will not be shared with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No