Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Parenting
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 10 patient and co-parent dyads (20 participants in total) will participate in the pilot study to evaluate the feasibility and acceptability of the FAMILY intervention. Preliminary effects of the intervention will also be examined.Masking: None (Open Label)Masking Description: Because this is a pilot study, all participant dyads will receive the same intervention and no blinding will take place.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
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 psychoeduca...
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.
Tracking Information
- NCT #
- NCT04092816
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Eliza M Park, MD University of North Carolina
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