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

Metastatic Breast Cancer Clinical Trial

— FAMILY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04092816
• Other study ID #: LCCC1920
• Secondary ID: 5K07CA218167-02
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: June 6, 2022

Study information

• Verified date: August 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Breast Cancer
• Parenting

Intervention

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.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Feasibility of Completion	Feasibility of Completion was evaluated by tracking the number of dyads that complete the study visits and study assessments. Numbers reflect from Baseline through 42 days given a flexible duration of intervention.	Up to 42 Days
Secondary	Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale	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.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Secondary	Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)	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.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Secondary	Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)	Assess the change in patient and co-parent's parenting concerns severity. The PCQ-AD is an investigator-adapted measure of parenting concerns measured on a 4-point scale. Total score range for the PCQ-AD is 0-3 with higher scores indicating greater distress.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Secondary	The Change in Patient and Co-parent's Illness-related Communication	The change in patient and co-parent's illness-related communication was measured by the Couples Illness Communication Scale (CICS).; 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. Total Score Range: 4-20, Higher is better.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Secondary	Patient's Health-related Quality of Life	Patient Health-related Quality of Life was assessed change in the patient's health-related quality of life measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (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. Total Score Range: 0-184; 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.; The numbers analyzed reflect all individuals who contributed data at each time point.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Secondary	Patient and Co-parent's Cancer-related Family Communication	Patient and Co-Parent's Cancer-related Family Communication was assessed 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. For the first 8 items, the score range is on a 4-point scale (1 to 4). The last item is graded on a 3-point scale (1 to 3). For all 9 items, higher is better. Due to the small sample size, each individual score item was reported.	Baseline, 7 Days, 14 Days, 28 Days, 42 Days

External Links

•   UNC Lineberger Comprehensive Cancer Center Clinical Trials