Clinical trial · Interventional
Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped prematurely due to difficulty meeting accrual and retention goals, exacerbated by the COVID-19 pandemic.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Parenting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAMILY Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FAMILY
- description
- Patient-co-parent dyads will participate in the FAMILY intervention in-person.
- interventionNames
- Behavioral: FAMILY Intervention
Primary outcomes (4)
- measure
- Acceptability of the Intervention
- timeFrame
- 42 Days
- description
- Acceptability of the intervention was defined as the number of participants who completed the study intervention. Participants' experience was assessed qualitatively, using post-intervention interviews.
- measure
- Acceptability of the Intervention Measured by the Study Visit Assessment Form
- timeFrame
- 7 Days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available