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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
53
Customized communication guidance to help parents with cancer talk about their cancer with their children.
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
Feasibility of Screening
The number of subjects who were screened, recruited, and retained in the study were reported.
Time frame: Baseline
Feasibility of Recruitment
Number of patients who enroll in the study
Time frame: 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.
Time frame: Baseline, 14 days, 84 days
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