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

NCT ID: NCT04092816

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2022-06-06

Brief 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.

Detailed 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.

Conditions

Metastatic Breast Cancer; Parenting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FAMILY

Patient-co-parent dyads will participate in the FAMILY intervention in-person.

Group Type: EXPERIMENTAL

FAMILY Intervention

Intervention Type: BEHAVIORAL

The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials.

Interventions

FAMILY Intervention

The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zev M Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://unclineberger.org/patientcare/clinical-trials/

UNC Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

5K07CA218167-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1920

Identifier Type: -

Identifier Source: org_study_id