Gynecologic Cancer
Conditions
Brief summary
This study is a prospective longitudinal cohort study with an embedded intervention. It follows participants with gynecologic malignancies and their informal caregivers over a 6-month period to assess caregiver distress, NMDOH, and patient outcomes.
Detailed description
Primary Objectives: Caregivers of patients with gynecologic cancers are at risk for significant distress, which is further impacted by NMDOH. Although caregiver distress affects patient outcomes, it is not routinely measured or addressed in the clinical setting, and little is known about disparities in caregivers' distress and burden in a diverse gynecologic cancer population. We, therefore, propose the following objectives: 1. To measure distress and define the NMDOH needs of caregivers of patients with gynecologic cancers 2. To address unmet needs of gynecologic cancer caregivers through a semi-automated system to navigate caregivers to NMDOH and caregiving resources 3. To evaluate changes over time in caregivers' unmet needs and distress following receipt of a semi-automated, targeted caregiver resource navigation (CRN) system, and to explore associations between changes in caregiver needs/distress and patients' cancer-related outcomes and distress.
Interventions
OTHERSurveys
Study surveys will be administered primarily in REDCap, or with the help of a coordinator (i.e. mailing surveys, over the phone, or with a tablet during clinic visits) if assistance is needed.
Sponsors
M.D. Anderson Cancer Center
Ovarian Cancer Research Alliance (OCRA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will include participants from two categories: Patients: 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator. 4. Patient presenting for initial or recurrence chemotherapy treatment for management of a gynecologic malignancy (cancer of the ovary, uterus, cervix, vulva, vagina, peritoneum, or fallopian tube) 5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement Caregivers: 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator. 4. Must be an identified caregiver of an enrolled patient 5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement The study will include patients with no caregiver, and only one caregiver may enroll per patient.
Exclusion criteria
Patients: 1\. Unwilling or unable to proceed beyond the consent statement step Caregivers 1\. Unwilling or unable to proceed beyond the consent statement step
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTAbigail Smith Zamorano, MD
PRINCIPAL_INVESTIGATORAbigail Smith Zamorano, MD
UT MD Anderson
Outcome results
None listed