Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention (NCT04092816) | Clinical Trial Compass
TerminatedNot Applicable
Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
Stopped: The study was stopped prematurely due to difficulty meeting accrual and retention goals, exacerbated by the COVID-19 pandemic.
United States15 participantsStarted 2019-10-30
Plain-language 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-parents. In this single-center study, we will recruit ten mothers with metastatic breast cancer and their co-parents as dyads (N=20) to participate in the Fathers and Mothers Invested in the Lives of their Youth (FAMILY) intervention. Patient and co-parent dyads will participate in 2-3 study visits with an intervention facilitator and a post-intervention feedback interview. Participants will also complete baseline and follow-up study surveys. The final products of this study will be the FAMILY intervention manual and training materials, and fidelity assessments.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of the Intervention
Timeframe: 42 Days
2
Acceptability of the Intervention Measured by the Study Visit Assessment Form