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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

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.

Interventions

  • Behavioral: 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Acceptability of the intervention assessed via semi-structured interview
    • Time Frame: 42 Days
    • Participants will be interviewed about their experiences with the study intervention.
  • Acceptability of the intervention measured by the study visit assessment form
    • Time Frame: 7 Days
    • Acceptability of the intervention will be assessed through participants’ satisfaction with the program. The study visit assessment form contains 14 items assessing satisfaction and experiences with the study visits on a Likert-type scale. Higher scores indicate greater satisfaction.
  • Acceptability of the intervention measured by the study visit assessment form
    • Time Frame: 14 Days
    • Acceptability of the intervention will be assessed through participants’ satisfaction with the program. The study visit assessment form contains 14 items assessing satisfaction and experiences with the study visits on a Likert-type scale. Higher scores indicate greater satisfaction.
  • Feasibility of Recruitment: Number of patient-co-parent dyads that are eligible to participate
    • Time Frame: Baseline
    • Assess how likely patient-co-parent dyads are to join the study through tracking the number of eligible dyads who participate in the study.

Secondary Measures

  • Feasibility of Completion: number of patient-caregiver dyads that complete the study
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess how likely patient-caregivers are to complete the study through tracking the number of dyads that complete the study visits and study assessments.
  • Emotional well-being measured by the Functional Assessment of Chronic Illness Therapy – Palliative Care (FACIT-Pal care) subscale
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess the change in patient’s emotional well-being through the FACIT-Pal Care; a 6-item self-report assessment of emotional well-being that is widely used in palliative care research. Score range is 0-24, higher scores indicate better emotional well-being.
  • Anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess the change in patient and co-parent’s depression and anxiety symptom severity. The HADS consists of two 7-item subscales assessing depression and anxiety symptoms separately. Score range for each subscale is 0-21, higher scores indicate greater symptoms.
  • Parenting concerns measured by the Parenting Concerns Questionnaire-Revised (PCQ-R)
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess the change in patient and co-parent’s parenting concerns severity. The PCQ-R is an investigator-adapted measure of parenting concerns measured on a 4-point scale. Total score range for the PCQ-R is 0-63 with higher scores indicating greater distress.
  • Couples’ communication measured by the Couples Illness Communication Scale (CICS)
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess the change in patient and co-parent’s illness-related communication. The CICS is a brief self-report measure of illness-related couple communication. The CICS consists of 4 items measured on a 5-point Likert-type scale.
  • Patient’s Health-related Quality of Life measured by the Functional Assessment of Chronic Illness Therapy – Palliative Care (FACIT-Pal)
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess change in the patient’s health-related quality of life measured by the FACIT-Pal; the FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life.
  • Patient and Co-parent’s cancer-related family communication measured by investigator-developed scale
    • Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
    • Assess changes in the patient and co-parent’s scores for a nine-item investigator-developed measure. The measure assesses participants’ confidence and preparation to engage in communication about the impact of parental cancer on children. Higher scores indicate greater confidence and preparedness.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UNC Lineberger Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eliza M Park, MD, Principal Investigator, University of North Carolina
  • Overall Contact(s)
    • Eliza M Park, MD, 919-966-3494, leeza_park@med.unc.edu

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