Diminish Chemotherapy Related Side Effects Through Patient Education

NCT04694794 | Completed

• 1 other identifier: PSCI-19-112
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapeutic Toxicity; Chemotherapeutic Agent Toxicity; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptom Assessment

  12 weeks

• Emotional Assessment

  12 weeks

• Baseline Educational Assessment

  Baseline

Other Outcomes (1)

• Feasibility Assessment

  12 weeks

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

Educational Brochure OTHER

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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to give informed consent
• Pregnant females
• Inability to understand or read written English
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

• Monali Vasekar, MD

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Single arm interventional study

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: March 24, 2021
• Primary Completion: March 19, 2023
• Study Completion: August 21, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)