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

Not Applicable

Completed

• Conditions: Parents; Neoplasms; Communication; Cancer; Parenting; Parent-Child Relations
• Interventions: Behavioral: FACT

• Registration Number: NCT04342871
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Study Start: 2020-10-05
• Primary Completion: 2021-07-27
• Study Completion: 2021-07-27
• Results First Submitted: 2022-07-11
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Results First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FACT	FACT	Patients will receive access to intervention materials.

Primary Outcome Measures

Name	Time	Method
Acceptability of the Intervention Assessed Via Semi-structured Interviews	14 days	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.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction	14 days	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.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful	14 days	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.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful	14 days	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.
Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Screening	Baseline	The number of subjects who were screened, recruited, and retained in the study were reported.
Feasibility of Recruitment	Baseline	Number of patients who enroll in the study
Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale	Baseline, 14 days, 84 days	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.

Trial Locations

Locations (2)

University of North Carolina Hospital; 🇺🇸 Chapel Hill, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States