Clinical trial NCT05377749: The Families Addressing Cancer Together Intervention for Parents With Cancer
Official title: Families Addressing Cancer Together (FACT): A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Cancer
Parenting
Communication
Parents
Parent-Child Relations
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Cancer Institute (NCI)
First posted: 2022-05-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Families Addressing Cancer Together (FACT) Satisfaction Scale
timeFrame: 3 weeks
measure: Acceptability as Measured by FACT Satisfaction Scale
timeFrame: 6 weeks
measure: Acceptability as Assessed by a Semi-structured, Post-intervention Interview
timeFrame: 6 weeks
Secondary outcomes:
measure: Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
timeFrame: 6 weeks
measure: Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey
timeFrame: 3 weeks
measure: Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.
timeFrame: 6 weeks
measure: Change From Baseline Communication Self-efficacy Using the CSES
timeFrame: Baseline, 3 weeks
measure: Change From Baseline Communication Self-efficacy Using the CSES
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Zev M Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: