Clinical trial NCT04342871: An Evaluation of the Families Addressing Cancer Together (FACT) Intervention
Official title: A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention
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
First posted: 2020-04-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Because this is a pilot study, all participants will receive the same intervention and no blinding will take place
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot feasibility and acceptability study to inform the development and testing of a novel communication intervention to support parents in their communication with children about cancer. The research questions to be answered by this study are whether the intervention being tested can be feasible and acceptable, and provide preliminary estimates of improvement in parental psychological distress.

Detailed description: This is a single-arm, single center pilot study using a pretest-posttest design to evaluate the feasibility and acceptability of a psychosocial intervention, Families Addressing Cancer Together (FACT). The purpose of the intervention is to decrease parental anxiety by facilitating parental communication about cancer with their children. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible, acceptable, and reduce parental psychological distress. Findings from this study will inform a future grant application to further test this intervention in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Informed consent reviewed and signed;
* Age equal to or above 18 years;
* Ability to understand and comply with study procedures;
* Be a parent, primary caregiver, or guardian of at least one child between the ages of 3-19 years old with whom the subject has regular contact. The child must have cognitive ability to understand verbal communication;
* Have a new or recurrent diagnosis of invasive solid tumor malignancy within the past 6 months or have a solid tumor cancer diagnosis with disease that is either stage IV or equivalent;
* Have a cancer diagnosis that is likely to require systemic anti-neoplastic therapy, non-office based surgical intervention, radiation therapy, or palliative care/hospice within the next three months.

Exclusion Criteria:

* Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.

Primary outcomes:
measure: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful
timeFrame: 14 days
measure: Acceptability of the Intervention Assessed Via Semi-structured Interviews
timeFrame: 14 days
measure: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful
timeFrame: 14 days
measure: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important
timeFrame: 14 days
measure: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction
timeFrame: 14 days
Secondary outcomes:
measure: Feasibility of Screening
timeFrame: Baseline
measure: Feasibility of Recruitment
timeFrame: Baseline
measure: Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale
timeFrame: Baseline, 14 days, 84 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Eliza Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park EM, Deal AM, Heiling HM, Jung A, Yopp JM, Bowers SM, Hanson LC, Song MK, Valle CG, Yi B, Cassidy A, Won H, Rosenstein DL. Families Addressing Cancer Together (FACT): feasibility and acceptability of a web-based psychosocial intervention for parents with cancer. Support Care Cancer. 2022 Oct;30(10):8301-8311. doi: 10.1007/s00520-022-07278-x. Epub 2022 Jul 13.