- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092816
Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention (FAMILY)
The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FAMILY
Patient-co-parent dyads will participate in the FAMILY intervention in-person.
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The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator.
Study visits are manualized and complemented by patient education materials.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the Intervention
Time Frame: 42 Days
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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.
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42 Days
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Acceptability of the Intervention Measured by the Study Visit Assessment Form
Time Frame: 7 Days
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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.
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7 Days
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Feasibility of Study Procedures
Time Frame: 14 Days
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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.
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14 Days
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Feasibility of Recruitment
Time Frame: Baseline
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Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Completion
Time Frame: Up to 42 Days
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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.
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Up to 42 Days
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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
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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.
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Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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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.
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Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)
Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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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.
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Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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The Change in Patient and Co-parent's Illness-related Communication
Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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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
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Patient's Health-related Quality of Life
Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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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
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Patient and Co-parent's Cancer-related Family Communication
Time Frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zev M Nakamura, MD, University of North Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LCCC1920
- 5K07CA218167-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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