Families Addressing Cancer Together (FACT) intervention plus questionnaires

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.

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

FACT

Zev M Nakamura, MD

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.

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.

The Families Addressing Cancer Together Intervention for Parents With Cancer

Families Addressing Cancer Together (FACT): A Pilot Randomized Trial

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.

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.

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.

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

Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point.

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,

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.

National Institute of Allergy and Infectious Diseases (NIAID)

National Cancer Institute (NCI)

UNC Lineberger Comprehensive Cancer Center

The protocol does not require adverse event assessment. Adverse Event Data was not collected.

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.

FACT Intervention

Wait-list Control Condition

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Zev Nakamura, MD

Families Addressing Cancer Together (FACT) Intervention

Participants who started the intervention and completed the post-intervention survey.

Families Addressing Cancer Together (FACT) Satisfaction Scale

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.

Subjects joined to the study and completed satisfaction survey.

Acceptability as Measured by FACT Satisfaction Scale

Not reported

Positive

Beneficial

Shortcomings

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

Number of Eligible Participants for Screening

Number of Participants Consented and Started

All participants were invited to the study including both arms.

All Subjects Approaced

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

Participants who started the study and completed the post-intervention survey.

Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey

Subjects joined to the study and completed the assessment.

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

Change From Baseline Communication Self-efficacy Using the CSES

Subjects who joined to the study and completed the assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Families Addressing Cancer Together Intervention for Parents With Cancer	NCT05377749	Neoplasms Cancer Parenting Communication Parents Parent-Child Re...	FACT	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
The Families Addressing Cancer Together Intervention for Parents With Cancer	NCT05377749	Neoplasms Cancer Parenting Communication Parents Parent-Child Re...	FACT	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for fact

Every month we try and update this database with for fact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fact

Every month we try and update this database with for fact cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.