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

NCT04092816 | Terminated Results DMC

• 2 other identifiers: LCCC19205K07CA218167-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer; Parenting

Keywords

Parenting

Outcome Measures

Primary Outcomes (4)

• Acceptability of the Intervention

  Acceptability of the intervention was defined as the number of participants who completed the study intervention. Participants' experience was assessed qualitatively, using post-intervention interviews.

  42 Days

• Acceptability of the Intervention Measured by the Study Visit Assessment Form

  The acceptability of the intervention was assessed through participants' satisfaction with the program. The Lyon Satisfaction questionnaire consists of 5-point Likert-type items assessing positive (six items) and negative (seven items) emotional reactions to the study visit. Responses were summed and reported for each subscale with higher scores meaning higher emotional reactions, and worse reactions. Positive subscale: 6-30 and negative subscale: 7-35.

  7 Days

• Feasibility of Study Procedures

  Feasibility of study procedures were assessed how likely patient-co-parent dyads are to join the study through tracking the number of eligible dyads who participate in the study.

  14 Days

• Feasibility of Recruitment

  Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study.

  Baseline

Secondary Outcomes (7)

• Feasibility of Completion

  Up to 42 Days

• Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale

  Baseline, 7 Days, 14 Days, 28 Days, 42 Days

• Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline, 7 Days, 14 Days, 28 Days, 42 Days

• Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)

  Baseline, 7 Days, 14 Days, 28 Days, 42 Days

• The Change in Patient and Co-parent's Illness-related Communication

  Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Study Arms (1)

FAMILY

EXPERIMENTAL

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

Behavioral: FAMILY Intervention

Interventions

FAMILY Intervention 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.

FAMILY

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination due to COVID-19 pandemic limiting research enrollment

Results Point of Contact

• Title: Zev Nakamura, MD
• Organization: University of North Carolina at Chapel Hill

zev_nakamura@med.unc.edu

984-974-3829

Study Officials

• Zev M Nakamura, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Because this is a pilot study, all participant dyads will receive the same intervention and no blinding will take place.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 17, 2019
• Study Start: October 30, 2019
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)