CompletedNCT05377749FACTUpdated May 23, 2024Results posted

The Families Addressing Cancer Together Intervention for Parents With Cancer

An interventional study of FACT in Neoplasms, Cancer and Parenting, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study summary

The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence and ability to talk about their cancer with their minor children. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition.

Read the detailed description

Parents with cancer are encouraged to be "honest and open" with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way.

The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.

Conditions studied

Neoplasms
Cancer
Parenting
Communication
Parents
Parent-Child Relations

In context

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Informed consent reviewed and signed;
Age equal to or above 18 years;
Ability to understand and comply with study procedures;
Able to complete all study measures and visits in English;
Be a parent (defined as biological, adoptive, foster, or step-parent), kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child age 3 to 17 years of age who can speak and understand English;
Have a diagnosis of Stage II-IV (or equivalent) invasive solid tumor not in surveillance or survivorship

Exclusion criteria

Exclusion Criteria:

Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
Prior participation in the pilot trial or development and user testing protocol preliminary to this study;
No current or expected contact with their child; or
Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 47 participants (actual)

Study arms

Experimental
FACT intervention
Families Addressing Cancer Together (FACT) intervention plus questionnaires
Behavioral: FACT
No intervention
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.

Interventions

BehavioralFACT
Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.

What researchers measure

Primary outcomes

Families Addressing Cancer Together (FACT) Satisfaction Scale
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.
Time frame: 3 weeks
Acceptability as Measured by FACT Satisfaction Scale
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.
Time frame: 6 weeks
Acceptability as Assessed by a Semi-structured, Post-intervention Interview
Satisfaction 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.
Time frame: 6 weeks

Secondary outcomes

Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study.
Time frame: 6 weeks
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete 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.
Time frame: 3 weeks
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.
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,
Time frame: 6 weeks
Change From Baseline Communication Self-efficacy Using the CSES
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.
Time frame: Baseline, 3 weeks
Change From Baseline Communication Self-efficacy Using the CSES
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.
Time frame: Baseline, 6 weeks

Results

Posted Feb 1, 2024

Participant flow

Participants were recruited from 07/05/2022 through 02/22/2023 at one cancer center in North Carolina.

Baseline Assessments

Participant flow — Baseline Assessments
Milestone	Families Addressing Cancer Together (FACT) Intervention	Wait-list Control Condition
Started	24	23
Completed	24	23
Not completed	0	0

3 Weeks

Participant flow — 3 Weeks
Milestone	Families Addressing Cancer Together (FACT) Intervention	Wait-list Control Condition
Started	24	23
Completed	21	18
Not completed	3	5
Withdrew: Lost to follow-up	2	4
Withdrew: Withdrawal by subject	1	1

Outcome measures

PrimaryFamilies Addressing Cancer Together (FACT) Satisfaction Scale

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.

Time frame:: 3 weeks
Reported as:: Mean · score on a scale

Families Addressing Cancer Together (FACT) Satisfaction Scale
score on a scale	Families Addressing Cancer Together (FACT) Intervention
Families Addressing Cancer Together (FACT) Satisfaction Scale	16.24 ± 2.48

PrimaryAcceptability as Measured by FACT Satisfaction Scale

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.

Time frame:: 6 weeks
Reported as:: Mean · score on a scale

Acceptability as Measured by FACT Satisfaction Scale
score on a scale	Families Addressing Cancer Together (FACT) Intervention
Acceptability as Measured by FACT Satisfaction Scale	13.15 ± 1.83

PrimaryAcceptability as Assessed by a Semi-structured, Post-intervention Interview

Satisfaction 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.

Time frame:: 6 weeks
Reported as:: Count of participants · Participants

Acceptability as Assessed by a Semi-structured, Post-intervention Interview
Participants	Positive	Beneficial	Recommended	Shortcomings
Yes	11	11	7	4
No	0	0	5	8
Not reported	1	1	0	0

SecondaryRecruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation

Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study.

Time frame:: 6 weeks
Reported as:: Count of participants · Participants

Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
Participants	All Subjects Approaced
Number of Eligible Participants for Screening	93
Number of Participants Consented and Started	47

SecondaryFeasibility of Participant Retention as Measured by Percentage of Participants Who Complete 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.

Time frame:: 3 weeks
Reported as:: Count of participants · Participants

Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey
Participants	Families Addressing Cancer Together (FACT) Intervention	Wait-list Control Condition
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey	21	18

SecondaryFeasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.

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,

Time frame:: 6 weeks
Reported as:: Count of participants · Participants

Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.
Participants	FACT Intervention	Wait-list Control Condition
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.	23	17

SecondaryChange From Baseline Communication Self-efficacy Using the CSES

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.

Time frame:: Baseline, 3 weeks
Reported as:: Mean · score on a scale

Change From Baseline Communication Self-efficacy Using the CSES
score on a scale	Families Addressing Cancer Together (FACT) Intervention	Wait-list Control Condition
Change From Baseline Communication Self-efficacy Using the CSES	6.46 ± 14.40	2.85 ± 9.28

SecondaryChange From Baseline Communication Self-efficacy Using the CSES

Time frame:: Baseline, 6 weeks
Reported as:: Mean · score on a scale

Change From Baseline Communication Self-efficacy Using the CSES
score on a scale	FACT Intervention	Wait-list Control Condition
Change From Baseline Communication Self-efficacy Using the CSES	9.47 ± 16.08	0.96 ± 14.10

Adverse events

Collected over Not available. The protocol does not require adverse event assessment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FACT Intervention	—	—	—
Wait-list Control Condition	—	—	—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	FACT Intervention	Wait-list Control Condition	Total
<=18 years	0	0	0
Between 18 and 65 years	24	23	47
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	FACT Intervention	Wait-list Control Condition	Total
Female	18	20	38
Male	6	3	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	FACT Intervention	Wait-list Control Condition	Total
Hispanic or Latino	0	2	2
Not Hispanic or Latino	24	21	45
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	FACT Intervention	Wait-list Control Condition	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	7	4	11
White	15	15	30
More than one race	1	2	3
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(participants)	FACT Intervention	Wait-list Control Condition	Total
United States	24	23	47

Study locations

1 site

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 31, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05377749
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: May 17, 2022
Start date: Jul 5, 2022
Primary completion: Feb 22, 2023
Completion: Feb 22, 2023
Results posted: Feb 1, 2024
Last update: May 23, 2024

Study contacts

Zev M Nakamura, MD

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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