Trial Outcomes & Findings for An Evaluation of the Families Addressing Cancer Together (FACT) Intervention (NCT NCT04342871)

NCT ID: NCT04342871

Last Updated: 2024-08-15

Results Overview

Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-08-15

Participant Flow

Subjects were recruited from October 2020 to April 2021 in one center in North Carolina. Although 53 participants consented, 5 subjects did not complete the baseline assessment, and 2 subjects' clinical conditions did not allow them to complete the study requirements. Forty -six participants received the baseline intervention, 35 out of 46 participants completed the 2-week intervention, and 29 out of 35 participants completed the 12-week intervention.

All participants were assigned to receive the intervention after completing baseline assessments.

Participant milestones

Measure	FACT Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.
Overall Study STARTED	53
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	FACT Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.
Overall Study Death	4
Overall Study Clinical deterioration/illness progression	2
Overall Study Did not complete baseline assessments	5
Overall Study Lost to Follow-up	13

Baseline Characteristics

An Evaluation of the Families Addressing Cancer Together (FACT) Intervention

Baseline characteristics by cohort

Measure	FACT n=53 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.
Age, Continuous	45.87 years STANDARD_DEVIATION 7.14 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants
Race (NIH/OMB) White	39 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.

Outcome measures

Measure	FACT Was Helpful n=29 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful Yes	26 Participants	—	—
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful No	3 Participants	—	—

PRIMARY outcome

Timeframe: 14 days

Population: Individuals who received intervention materials and participated in semi-structured feedback interview

Participants were interviewed about their experiences with the study intervention using semi-structured interviews. Parents' comments on the intervention "helped them feel more comfortable and prepared to talk with their children about their illness" were graded as participants overall intervention satisfaction.

Outcome measures

Measure	FACT Was Helpful n=10 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Acceptability of the Intervention Assessed Via Semi-structured Interviews Intervention was satisfactory	10 Participants	—	—
Acceptability of the Intervention Assessed Via Semi-structured Interviews Intervention was not satisfactory	0 Participants	—	—

PRIMARY outcome

Timeframe: 14 days

Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.

Outcome measures

Measure	FACT Was Helpful n=29 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful Yes	26 Participants	—	—
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful No	3 Participants	—	—

PRIMARY outcome

Timeframe: 14 days

Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.

Outcome measures

Measure	FACT Was Helpful n=29 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important Yes	27 Participants	—	—
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important No	2 Participants	—	—

PRIMARY outcome

Timeframe: 14 days

Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.

Outcome measures

Measure	FACT Was Helpful n=29 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction Yes	27 Participants	—	—
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction No	2 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Number of individuals who were assessed for eligibility and found to eligible

The number of subjects who were screened, recruited, and retained in the study were reported.

Outcome measures

Measure	FACT Was Helpful n=69 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Feasibility of Screening Screened	69 Participants	—	—
Feasibility of Screening Recruited/consented	53 Participants	—	—
Feasibility of Screening Completed baseline intervention	46 Participants	—	—
Feasibility of Screening Completed 2-week intervention	35 Participants	—	—
Feasibility of Screening Completed 12-week intervention	29 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Number of individuals eligible for participation who enrolled in the study.

Number of patients who enroll in the study

Outcome measures

Measure	FACT Was Helpful n=53 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days Number of participants completed at 14 days.	84 Days Number of participants completed at 84 days.
Feasibility of Recruitment Number who consented for participation	53 Participants	—	—
Feasibility of Recruitment Number who completed baseline assessments to receive intervention	46 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, 14 days, 84 days

Population: Participants who completed the Communication self-efficacy scale at baseline, 14 days, and 84 days.

Assess the change in patient's communication self-efficacy. The adapted Communication Self-Efficacy scale is a 9-item Visual Analogue Scale assessing parent's confidence in their ability to tell their child about parental medical illness. The score range is 0 to 100 with higher scores indicating higher confidence.

Outcome measures

Measure	FACT Was Helpful n=46 Participants Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children.	14 Days n=34 Participants Number of participants completed at 14 days.	84 Days n=27 Participants Number of participants completed at 84 days.
Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale	78.8 score on a scale Standard Deviation 20.6	82.8 score on a scale Standard Deviation 20.2	82.8 score on a scale Standard Deviation 23.5

Adverse Events

FACT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eliza Park

UNC Lineberger

Phone: 919-966-3494

Email: leeza_park@med.unc.edu

Results disclosure agreements

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