Clinical trial NCT04092816: Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
Official title: The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Breast Cancer
Parenting
Keywords: Parenting
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the Intervention
timeFrame: 42 Days
measure: Acceptability of the Intervention Measured by the Study Visit Assessment Form
timeFrame: 7 Days
measure: Feasibility of Study Procedures
timeFrame: 14 Days
measure: Feasibility of Recruitment
timeFrame: Baseline
Secondary outcomes:
measure: Feasibility of Completion
timeFrame: Up to 42 Days
measure: Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
measure: Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
measure: Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
measure: The Change in Patient and Co-parent's Illness-related Communication
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
measure: Patient's Health-related Quality of Life
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
measure: Patient and Co-parent's Cancer-related Family Communication
timeFrame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Zev M Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: