A Pilot Study of a Triadic Communication Intervention to Improve Supportive Oncology Care Delivery Among Patients and Caregivers Facing Advanced Cancer
Kristin Levoy
Primary Investigator
Brief description of study
What is the purpose of this study?
The purpose of this study is to help test an idea designed to foster more supportive talk between doctors or nurse practitioners, patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies as primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.
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?
- Patient, caregiver, and provider triads in the control group will be recruited and assessed first, followed by the intervention group. The study transpires over the course of three sequential outpatient oncology visits or for up to three months, whichever comes first.
- The gynecologic oncology providers that staff the gynecology oncology clinics at IUSCCC will be consented up front, via verbal, phone-based consent, before patient and caregiver recruitment begins. Only the patients and caregivers of consented gynecologic oncology providers will be recruited to participate in the study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Gynecologic Cancer
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Age: Between 18 Years - 100 Years
-
Gender: Female
Inclusion criteria:
Patients will:
1. Be an adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
2. Not be receiving specialty palliative care or hospice,
3. Read/speak English***, and
4. Be able to provide written informed consent.
5. Anticipated to be seen at least twice during the 3-month study follow-up period (e.g., patients being seen on an every three-month schedule or more frequently)
Caregivers will:
1. Identify as the individual who is primarily involved in the patient’s care,
2. Be able to attend the oncology visits,
3. Read/speak English***, and
4. Be able to provide written informed consent.
Providers will:
1. Specialize in gynecologic oncology, and
2. Provide outpatient care at an IU Health gynecologic oncology clinic.
• In addition, patients and/or caregivers will be excluded if either one or both demonstrate:
1. Cognitive impairment
2. Speech/hearing difficulties precluding participation.
