Trial Outcomes & Findings for The Families Addressing Cancer Together Intervention for Parents With Cancer (NCT NCT05377749)
NCT ID: NCT05377749
Last Updated: 2024-05-23
Results Overview
Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction.
COMPLETED
NA
47 participants
3 weeks
2024-05-23
Participant Flow
Participants were recruited from 07/05/2022 through 02/22/2023 at one cancer center in North Carolina.
During this period, there have been 93 potential subjects who could be approached for screening. In total 47 subjects were found eligible for the study and started.
Participant milestones
| Measure |
Families Addressing Cancer Together (FACT) Intervention
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Wait-list Control Condition
Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention.
|
|---|---|---|
|
Baseline Assessments
STARTED
|
24
|
23
|
|
Baseline Assessments
COMPLETED
|
24
|
23
|
|
Baseline Assessments
NOT COMPLETED
|
0
|
0
|
|
3 Weeks
STARTED
|
24
|
23
|
|
3 Weeks
COMPLETED
|
21
|
18
|
|
3 Weeks
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Families Addressing Cancer Together (FACT) Intervention
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Wait-list Control Condition
Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention.
|
|---|---|---|
|
3 Weeks
Lost to Follow-up
|
2
|
4
|
|
3 Weeks
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
The Families Addressing Cancer Together Intervention for Parents With Cancer
Baseline characteristics by cohort
| Measure |
FACT Intervention
n=24 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Wait-list Control Condition
n=23 Participants
Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Participants who started the intervention and completed the post-intervention survey.
Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=20 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Families Addressing Cancer Together (FACT) Satisfaction Scale
|
16.24 score on a scale
Standard Deviation 2.48
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Subjects joined to the study and completed satisfaction survey.
Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=23 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Acceptability as Measured by FACT Satisfaction Scale
|
13.15 score on a scale
Standard Deviation 1.83
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 weeksSatisfaction with FACT will be assessed via semi-structured, post-intervention interviews. Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=12 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
n=12 Participants
Described specific beneficial components
|
Recommended
n=12 Participants
Recommended changes or suggestions
|
Shortcomings
n=12 Participants
Identified shortcomings
|
|---|---|---|---|---|
|
Acceptability as Assessed by a Semi-structured, Post-intervention Interview
Yes
|
11 Participants
|
11 Participants
|
7 Participants
|
4 Participants
|
|
Acceptability as Assessed by a Semi-structured, Post-intervention Interview
No
|
0 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
|
Acceptability as Assessed by a Semi-structured, Post-intervention Interview
Not reported
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All participants were invited to the study including both arms.
Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=93 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
Number of Eligible Participants for Screening
|
93 Participants
|
—
|
—
|
—
|
|
Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
Number of Participants Consented and Started
|
47 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Participants who started the study and completed the post-intervention survey.
Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=23 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
n=23 Participants
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey
|
21 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Subjects joined to the study and completed the assessment.
Percentage of enrolled participants who complete at least one study survey (any) at the 6-week time point.The number of participants who completed the assessment,
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=24 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
n=23 Participants
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.
|
23 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Participants who started the study and completed the post-intervention survey.
Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=21 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
n=18 Participants
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Change From Baseline Communication Self-efficacy Using the CSES
|
6.46 score on a scale
Standard Deviation 14.40
|
2.85 score on a scale
Standard Deviation 9.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Subjects who joined to the study and completed the assessment.
Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy.
Outcome measures
| Measure |
Families Addressing Cancer Together (FACT) Intervention
n=23 Participants
Families Addressing Cancer Together (FACT) intervention plus questionnaires
FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
|
Beneficial
n=17 Participants
Described specific beneficial components
|
Recommended
Recommended changes or suggestions
|
Shortcomings
Identified shortcomings
|
|---|---|---|---|---|
|
Change From Baseline Communication Self-efficacy Using the CSES
|
9.47 score on a scale
Standard Deviation 16.08
|
0.96 score on a scale
Standard Deviation 14.10
|
—
|
—
|
Adverse Events
FACT Intervention
Wait-list Control Condition
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 Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place