An Evaluation of the Fathers and Mothers With Cancer Communication Tool

Cancer Clinical Trial

— Fam-CT  

Official title:

A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Fathers and Mothers With Cancer Communication Tool (Fam-CT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342871
• Other study ID #: LCCC2030
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: July 27, 2021

Study information

• Verified date: October 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-arm, single center pilot study using a pretest-posttest design to evaluate the feasibility and acceptability of a novel psychosocial intervention, Fathers and Mothers with cancer Communication Tool (Fam-CT). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or hematologic malignancy within the past four weeks;
• 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.

Related Conditions & MeSH terms

• Cancer
• Communication
• Neoplasms
• Parent-Child Relations
• Parenting
• Parents

Intervention

Behavioral:
• Fam-CT
Customized communication guidance to help parents with cancer talk about their cancer with their children.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the intervention assessed via semi-structured interviews	Participants will be interviewed about their experiences with the study intervention	14 days
Primary	Acceptability of the intervention measured by the study visit satisfaction form	Acceptability of the intervention will be assessed through participants' satisfaction ratings used a study-specific satisfaction scale, "Fathers and Mothers with cancer - Communication Tool (Fam-CT) satisfaction scale." Higher scores indicate more satisfaction with a total score range of 0-12.	14 days
Secondary	Feasibility of screening	Number of patients who eligible for the study	Baseline
Secondary	Feasibility of recruitment	Number of patients who enroll in the study	Baseline
Secondary	Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS)	Assess the change in patient's anxiety symptom severity. The HADS consists of two 7-item subscales assessing depression and anxiety symptoms. Scor range for each subscale is 0-21, higher scores indicate greater symptoms.	Baseline, 14 days, 84 days
Secondary	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 900 with higher scores indicating higher confidence.	Baseline, 14 days, 84 days
Secondary	Communication Behaviors measured by the Parental Cancer Communication Questionnaire	Assess the change in patient's communication behaviors using a study-specific communication instrument, the Parental Cancer Communication Questionnaire. The two items that will be used in the measure are: whether the parent discussed their illness with their child (yes/no); and whether the parent had follow-up conversations with their child about their illness (yes/no)	Baseline, 14 days, 84 days

External Links

•   UNC Lineberger Comprehensive Cancer Center