Chemotherapeutic ToxicityD-CRSENCT04694794
Diminish Chemotherapy Related Side Effects Through Patient Education
A study testing Educational Brochure in people with Chemotherapeutic Toxicity and Chemotherapeutic Agent Toxicity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity, Chemotherapy Effect
- What is being tested?
- Educational Brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Being tested
- Educational Brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational BrochureOther
Participants will be provided with Education Brochure developed by the study team to provide information to patients about managing side effects related to chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Single arm, interventional. All participants will be administered Educational Brochure to educate them regarding management of side effects experienced during chemotherapy treatment Receives: Other: Educational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start24 Mar 2021
- Primary completion19 Mar 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic ToxicityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm interventional study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monali Vasekar, Milton S. Hershey Medical Center
- Investigators
- Monali Vasekar, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694794
- Sponsor's protocol ID
- PSCI-19-112
- Acronym
- D-CRSE
- Status last verified
- Aug 2023
- First submitted
- 31 Dec 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information will be collected in De identified manner . IPD will not be shared with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-CRSE: Diminish Chemotherapy Related Side Effects Through Patient Education in Patients With Breast OR Gastrointestinal Cancer Who Are Undergoing Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT04694794
- Acronym / sponsor ID
- D-CRSE / PSCI-19-112
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Educational BrochureSingle arm, interventional. All participants will be administered Educational Brochure to educate them regarding management of side effects experienced during chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational BrochureParticipants will be provided with Education Brochure developed by the study team to provide information to patients about managing side effects related to chemotherapy | Other | Interventional |
Primary outcome
Utility of Educational Brochure assessment
Time frame: 12 weeks
• 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.
3 secondary outcomes
Symptom Assessment
Time frame: 12 weeks
Emotional Assessment
Time frame: 12 weeks
Baseline Educational Assessment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No. Information will be collected in De identified manner . IPD will not be shared with any other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monali Vasekar, MD principal investigator
Penn State Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Brochure in people with Chemotherapeutic Toxicity and Chemotherapeutic Agent Toxicity, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of Educational Brochure assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.