Single arm, interventional. All participants will be administered Educational Brochure to educate them regarding management of side effects experienced during chemotherapy treatment

Participants will be provided with Education Brochure developed by the study team to provide information to patients about managing side effects related to chemotherapy

Educational Brochure

Monali Vasekar, MD

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.

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.

Diminish Chemotherapy Related Side Effects Through Patient Education

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

Information will be collected in De identified manner . IPD will not be shared with any other researchers.

• Measure of participant withdraw rate from study as a representation of feasibility.

• 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.

• 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.

• 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.

• Identification of participants with immediate family member (child, spouse, parent) who underwent cytotoxic chemotherapy and participant's education level through questionnaire.

Milton S. Hershey Medical Center

Assistant Professor of Medicine

Blood and Lymph Conditions

All Conditions

Neoplasms

Digestive System Diseases

Anemia

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician.

Educational brochure

The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.

Standard pamphlet

Kenneth G Schellhase, MD MPH

Alan Mast, MD PHD

Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diminish Chemotherapy Related Side Effects Through Patient Education	NCT04694794	Chemotherapeuti... Chemotherapeuti... Chemotherapy Ef...	Educational Bro...	18 Years -	Milton S. Hershey Medical Center
Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors	NCT00772083	Anemia Colorectal Canc...	Educational bro... Standard pamphl...	18 Years -	Medical College of Wisconsin
Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors	NCT00772083	Anemia Colorectal Canc...	Educational bro... Standard pamphl...	18 Years -	Medical College of Wisconsin
Diminish Chemotherapy Related Side Effects Through Patient Education	NCT04694794	Chemotherapeuti... Chemotherapeuti... Chemotherapy Ef...	Educational Bro...	18 Years -	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for educational brochure