An Evaluation of the Families Addressing Cancer Together (FACT) Intervention (FACT)

A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Cancer; Communication; Parent-Child Relations; Parenting; Parents
• Intervention / Treatment: Behavioral: FACT

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FACT; Patients will receive access to intervention materials.	Behavioral: FACT; Customized communication guidance to help parents with cancer talk about their cancer with their children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful	Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.	14 days
Acceptability of the Intervention Assessed Via Semi-structured Interviews	Participants were interviewed about their experiences with the study intervention using semi-structured interviews. Parents' comments on the intervention "helped them feel more comfortable and prepared to talk with their children about their illness" were graded as participants overall intervention satisfaction.	14 days
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful	Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.	14 days
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important	Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.	14 days
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction	Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Families Addressing Cancer Together (FACT) satisfaction scale." Four-items (0=not at all, 3=very), higher scores indicate more satisfaction.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Screening	The number of subjects who were screened, recruited, and retained in the study were reported.	Baseline
Feasibility of Recruitment	Number of patients who enroll in the study	Baseline
Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale	Assess the change in patient's communication self-efficacy. The adapted Communication Self-Efficacy scale is a 9-item Visual Analogue Scale assessing parent's confidence in their ability to tell their child about parental medical illness. The score range is 0 to 100 with higher scores indicating higher confidence.	Baseline, 14 days, 84 days

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Eliza Park, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Helpful Links

• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): July 27, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LCCC2030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No