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 range18 Years – 99 Years

SexALL

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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 …

What they're measuring

Acceptability of the Intervention

Timeframe: 42 Days

Acceptability of the Intervention Measured by the Study Visit Assessment Form

Timeframe: 7 Days

Feasibility of Study Procedures

Timeframe: 14 Days

Feasibility of Recruitment

Timeframe: Baseline

Trial details

NCT IDNCT04092816

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-06

Results submitted2023-04-17