Metastatic Breast CancerFAMILYNCT04092816
Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention
A study testing FAMILY Intervention in people with Metastatic Breast Cancer and Parenting, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Breast Cancer, Parenting
- What is being tested?
- FAMILY Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer, Parenting
- Being tested
- FAMILY Intervention
- Keywords
- Parenting
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMILY InterventionBehavioural
The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials.
| Study group | Role | What they receive |
|---|---|---|
| FAMILY | Experimental | Patient-co-parent dyads will participate in the FAMILY intervention in-person. Receives: Behavioral: FAMILY Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Up to 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
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.
Measured: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start30 Oct 2019
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Why it stopped: The study was stopped prematurely due to difficulty meeting accrual and retention goals, exacerbated by the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zev M Nakamura, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092816
- Sponsor's protocol ID
- LCCC1920
- Other IDs
- 5K07CA218167-02
- Acronym
- FAMILY
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2019
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
- ClinicalTrials.gov ID
- NCT04092816
- Acronym / sponsor ID
- FAMILY / LCCC1920
- Conditions
- Metastatic Breast Cancer, Parenting
- Keywords
- Parenting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to difficulty meeting accrual and retention goals, exacerbated by the COVID-19 pandemic.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| FAMILY | Experimental | Behavioral: FAMILY InterventionPatient-co-parent dyads will participate in the FAMILY intervention in-person. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAMILY InterventionThe FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials. | Behavioural | FAMILY |
Primary outcome
Acceptability of the Intervention
Time frame: 42 Days
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.
Acceptability of the Intervention Measured by the Study Visit Assessment Form
Time frame: 7 Days
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.
Feasibility of Study Procedures
Time frame: 14 Days
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.
Feasibility of Recruitment
Time frame: Baseline
Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study.
7 secondary outcomes
Feasibility of Completion
Time frame: Up to 42 Days
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
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
The Change in Patient and Co-parent's Illness-related Communication
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Patient's Health-related Quality of Life
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Patient and Co-parent's Cancer-related Family Communication
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev M Nakamura, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMILY Intervention in people with Metastatic Breast Cancer and Parenting, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention (time frame: 42 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.