Trial Outcomes & Findings for Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention (NCT NCT04092816)

NCT ID: NCT04092816

Last Updated: 2023-08-21

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 42 Days
• Results posted on: 2023-08-21

Participant Flow

Participants were recruited from 10/30/2019 through 01/25/2022 at one cancer center in North Carolina.

A total of 15 subjects (8 patients and 7 co-parents) consented and were found eligible for the study.

Participant milestones

Measure	Patients Subjects who are diagnosed with cancer.	Co-parents Subjects who are spouses of patients with cancer.
Overall Study STARTED	5	5
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Patients Subjects who are diagnosed with cancer.	Co-parents Subjects who are spouses of patients with cancer.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient n=8 Participants Subjects who are diagnosed with cancer.	Co-parent n=7 Participants Subjects who are spouses of patients with cancer.	Total n=15 Participants Total of all reporting groups
Age, Continuous	40.75 years STANDARD_DEVIATION 8.65 • n=5 Participants	45.67 years STANDARD_DEVIATION 10.21 • n=7 Participants	42.86 years STANDARD_DEVIATION 9.31 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 Days

Population: The number of total participants who started the intervention and completed post-intervention semi-structured interview.

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Acceptability of the Intervention The patient and co-parent completed a post-intervention interview.	7 Participants	—
Acceptability of the Intervention The patient and co-parent started the study.	10 Participants	—

PRIMARY outcome

Timeframe: 7 Days

Population: 10 Subjects completed the study visit assessment

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Acceptability of the Intervention Measured by the Study Visit Assessment Form Positive emotions	26.6 score on a scale Standard Deviation 5.3	—
Acceptability of the Intervention Measured by the Study Visit Assessment Form Negative emotions	11.7 score on a scale Standard Deviation 2.8	—

PRIMARY outcome

Timeframe: 14 Days

Population: The number of participants (patient and co-parent) who started the intervention.

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.

Outcome measures

Measure	FAMILY n=5 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents n=5 Participants Subjects who are spouses of patients with cancer.
Feasibility of Study Procedures Started	5 Participants	5 Participants
Feasibility of Study Procedures Completed	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All 18 participants/co-parents were approached by the study team.

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

Outcome measures

Measure	FAMILY n=9 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents n=9 Participants Subjects who are spouses of patients with cancer.
Feasibility of Recruitment Eligible	9 Participants	9 Participants
Feasibility of Recruitment Consented	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 42 Days

Population: The number of participants (patient and co-parent) consented and completed study visits.

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.

Outcome measures

Measure	FAMILY n=8 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents n=7 Participants Subjects who are spouses of patients with cancer.
Feasibility of Completion Enrolled	8 Participants	7 Participants
Feasibility of Completion Baseline	6 Participants	5 Participants
Feasibility of Completion 7 days	5 Participants	5 Participants
Feasibility of Completion 14 days	4 Participants	3 Participants
Feasibility of Completion 28 days	2 Participants	2 Participants
Feasibility of Completion 42 days	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Baseline, patient participants only

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.

Outcome measures

Measure	FAMILY n=5 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale 7 days	18.0 units on a scale Standard Deviation 4.5	—
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale 14 days	13.7 units on a scale Standard Deviation 1.2	—
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale 28 days	20.5 units on a scale Standard Deviation 2.1	—
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale Baseline	16.4 units on a scale Standard Deviation 4.3	—

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Numbers analyzed reflect participants at each time point.

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) Baseline Anxiety	8.6 score on a scale Standard Deviation 2.8	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) Baseline Depression	5.1 score on a scale Standard Deviation 3.8	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 7 Days Anxiety	8.1 score on a scale Standard Deviation 2.4	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 7 Days Depression	5.7 score on a scale Standard Deviation 4.3	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 14 Days Anxiety	9.0 score on a scale Standard Deviation 1.7	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 14 Days Depression	6.0 score on a scale Standard Deviation 4.3	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 28 Days Anxiety	9.3 score on a scale Standard Deviation 2.2	—
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) 28 Days Depression	3.3 score on a scale Standard Deviation 2.2	—

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Number analyzed reflects the number of participants at each time point contributing data.

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) Baseline	1.8 score on a scale Standard Deviation 0.6	—
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) 7 Days	1.5 score on a scale Standard Deviation 0.7	—
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) 14 Days	1.5 score on a scale Standard Deviation 0.6	—
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) 28 Days	1.1 score on a scale Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Numbers reflect participants at each time point given flexible duration of intervention.

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
The Change in Patient and Co-parent's Illness-related Communication Baseline	12.5 score on a scale Standard Deviation 3.0	—
The Change in Patient and Co-parent's Illness-related Communication 7 Days	14.1 score on a scale Standard Deviation 2.2	—
The Change in Patient and Co-parent's Illness-related Communication 14 Days	13.6 score on a scale Standard Deviation 4.5	—
The Change in Patient and Co-parent's Illness-related Communication 28 Days	14.3 score on a scale Standard Deviation 4.4	—

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Only patient participants completed the measure.

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.

Outcome measures

Measure	FAMILY n=5 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Patient's Health-related Quality of Life Baseline	122.8 score on a scale Standard Deviation 36.1	—
Patient's Health-related Quality of Life 7 Days	122.8 score on a scale Standard Deviation 44.4	—
Patient's Health-related Quality of Life 14 Days	138.7 score on a scale Standard Deviation 24.1	—
Patient's Health-related Quality of Life 28 Days	162.5 score on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline, 7 Days, 14 Days, 28 Days, 42 Days

Population: Numbers analyzed reflect all participants who contributed data at each time point.

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.

Outcome measures

Measure	FAMILY n=10 Participants Patient-co-parent dyads will participate in the FAMILY intervention in-person. 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.	Co-parents Subjects who are spouses of patients with cancer.
Patient and Co-parent's Cancer-related Family Communication Baseline - comfort talking with children	2.8 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication Baseline - comfort talking with partner	3.7 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication Baseline - comfort talking about children's future needs	3.4 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication Baseline - prepared to talk with children	2.7 score on a scale Standard Deviation 0.9	—
Patient and Co-parent's Cancer-related Family Communication Baseline - prepared to talk with partner	3.5 score on a scale Standard Deviation 0.7	—
Patient and Co-parent's Cancer-related Family Communication Baseline - prepared to talk about children's future needs	3.5 score on a scale Standard Deviation 0.7	—
Patient and Co-parent's Cancer-related Family Communication Baseline - understand partner	1.4 score on a scale Standard Deviation 0.7	—
Patient and Co-parent's Cancer-related Family Communication Baseline - spending time with children	3.6 score on a scale Standard Deviation 1.4	—
Patient and Co-parent's Cancer-related Family Communication Baseline - prior conversations with children	1.9 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - comfort talking with children	2.6 score on a scale Standard Deviation 0.8	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - comfort talking with partner	3.2 score on a scale Standard Deviation 0.4	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - comfort talking about children's future needs	3.5 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - prepared to talk with children	2.5 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - prepared to talk with partner	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - prepared to talk about children's future needs	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - understand partner	1.4 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - spending time with children	4.6 score on a scale Standard Deviation 0.7	—
Patient and Co-parent's Cancer-related Family Communication 7 Days - prior conversations with children	2.0 score on a scale Standard Deviation 0.9	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - comfort talking with children	3.0 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - comfort talking with partner	3.0 score on a scale Standard Deviation 0.6	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - comfort talking about children's future needs	3.0 score on a scale Standard Deviation 0.6	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - prepared to talk with children	3.0 score on a scale Standard Deviation 0.6	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - prepared to talk with partner	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - prepared to talk about children's future needs	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - understand partner	1.1 score on a scale Standard Deviation 0.4	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - spending time with children	4.1 score on a scale Standard Deviation 0.7	—
Patient and Co-parent's Cancer-related Family Communication 14 Days - prior conversations with children	2.1 score on a scale Standard Deviation 0.9	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - comfort talking with children	3.0 score on a scale Standard Deviation 0.8	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - comfort talking with partner	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - comfort talking about children's future needs	3.3 score on a scale Standard Deviation 0.5	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - prepared to talk with children	3.0 score on a scale Standard Deviation 0.8	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - prepared to talk with partner	3.0 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - prepared to talk about children's future needs	3.0 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - understand partner	1.5 score on a scale Standard Deviation 1.0	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - spending time with children	4.5 score on a scale Standard Deviation 0.6	—
Patient and Co-parent's Cancer-related Family Communication 28 Days - prior conversations with children	2.0 score on a scale Standard Deviation 1.2	—

Adverse Events

FAMILY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zev Nakamura, MD

University of North Carolina at Chapel Hill

Phone: 984-974-3829

Email: zev_nakamura@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place