An Evaluation of the Fathers and Mothers With Cancer Communication Tool

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations

Intervention / Treatment
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* Behavioral: Fam-CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Because this is a pilot study, all participants will receive the same intervention and no blinding will take place
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fam-CT<br>Patients will receive access to intervention materials. | Behavioral: Fam-CT<br>* Customized communication guidance to help parents with cancer talk about their cancer with their children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the intervention assessed via semi-structured interviews | Participants will be interviewed about their experiences with the study intervention | 14 days | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of screening | Number of patients who eligible for the study | Baseline | 
| Feasibility of recruitment | Number of patients who enroll in the study | Baseline | 
| 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 | 
| 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 | 
| 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 |