Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention — FAMILY  

Metastatic Breast Cancer Clinical Trial

Official title: The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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 FAMILY intervention consists of manualized visits with a trained intervention facilitator and psychoeducation materials to help parents cope with cancer-related parenting concerns. The purpose of the intervention is to improve parenting concerns, emotional well-being, and end-of-life (EOL) preparation among participants. This study will evaluate whether a psychosocial intervention to reduce psychological distress and improve EOL preparation for mothers with metastatic breast cancer and their co-parents can be acceptable, feasible, and relevant to the target patient population.

This study is needed in order to generate critical data to: (1) refine the intervention in preparation for a pilot efficacy randomized controlled trial (RCT); and to generate preliminary data demonstrating the feasibility and acceptability of core intervention components. The preliminary data will support future grant applications for a full-scale efficacy RCT. ;

Related Conditions & MeSH terms

• Metastatic Breast Cancer
• Parenting

• NCT number: NCT04092816
• Study type: Interventional
• Source: UNC Lineberger Comprehensive Cancer Center
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2019
• Completion date: June 6, 2022