Status:
TERMINATED
Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Breast Cancer
Parenting
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and their co-paren...
Detailed Description
Cancer is the leading disease-specific cause of early parental death in the United States and having dependent children worsens suffering for parents with advanced cancer and their families. The FAMIL...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients:
- Be a woman with metastatic (stage IV) breast cancer who has either: (1) estrogen (ER), progesterone (PR), or HER2 receptor-negative cancer and disease progression beyond first line of therapy, or (2) ER, PR, or HER2 -positive cancer and disease progression beyond two lines of therapy;
- A mother of at least one dependent child, defined as a child \<18 years of age who lives at least half-time in the home;
- Be at least 18 years of age;
- Adequate stamina to complete at least two study visits
- Able to provide informed consent
- Able to complete all study measures and visits in English;
- Be willing to participate in study visits at the North Carolina Cancer Hospital (NCCH) if they live \>75 miles away from NCCH
- Have an identified co-parent who is eligible and willing to participate in the study.
- Inclusion Criteria for Co-parents:
- Be an adult man or woman who is both a partners or spouse of the patient and who would serve as the child(ren)'s primary caregiver if the patient were to become unavailable;
- Able to provide informed consent;
- Able to complete all study measures and visits in English;
- Stated willingness to comply with all study procedures; and
- Be at least 18 years of age.
- Exclusion Criteria for patients and co-parents:
- Unable to participate in study visits due to illiteracy, inability to speak English or other causes.
- Live more than 75-miles away from the North Carolina Cancer Hospital (NCCH) and unable to attend study visits at NCCH (participants who live more than 75-miles away and can attend study visits at NCCH remain eligible for participation).
- Unwilling to be audio-recorded during facilitated study visits and feedback interview.
Exclusion
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04092816
Start Date
October 30 2019
End Date
June 6 2022
Last Update
August 21 2023
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599