Real-Time Monitoring of Patient Centered Outcomes in English And Non-English-Speaking Patients Undergoing Radiation Treatment and its Impact on Overcoming Language Barriers
J
Jordan Holmes
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
126 participants needed
4 Locations
Brief description of study
What is the purpose of this study?
The purpose of this study is to evaluate if asking patients to complete surveys about their symptoms and quality of life during radiation treatment in real time improves management of symptoms and side effects commonly experienced during radiation treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Participants will be randomly put into one of two groups and will be in the study for about 10 months.
- Researchers will collect information about medical history (such as cancer diagnosis, treatments received, and any other medical conditions etc.) and demographics (such as age, gender, ethnicity etc.) from medical records.
- Researchers will collect information from clinic visits with treating physician during the study.
- Participants will answer survey questions about symptoms they areexperiencing and their quality of life; surveys will be completed at the following timepoints:
- within 2 weeks prior to the start of your radiation treatment
- weekly during your radiation treatment
- at the end of radiation treatment
- at 1 month and 6 months after you complete radiation treatment
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: cancer, radiation therapy,
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
1.
Age≥
18 at time of consent.
2.
Ability
to provide written informed consent and HIPAA authorization.
3.
Patients
must be English or Spanish speaking
4.
Pathologically
proven diagnosis of endometrial, cervical, or prostate cancer.
5.
Planning
to receive definitive or adjuvant radiation therapy (≥ 20 fractions of EBRT)
(+/- chemotherapy or hormonal therapy) with curative intent as part of standard
of care.
Exclusion Criteria:
1.
Patients
taking part in other clinical trials involving the completion of extensive
patient reported outcome or quality of life measures
2.
Patients
exhibiting overt psychopathology/cognitive dysfunction in the opinion of the treating
investigator and/or principal investigator.
3.
Prior
invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years.
4.
Prior
radiation to the pelvis
5.
Prior
treatment with platinum-based chemotherapy that is outside of the current
treatment window
6.
Prior
exposure to hormonal treatment that is outside of the current treatment window
Updated on
01 Aug 2024.
Study ID: 13393, CTO-IUSCCC-0765
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