The Families Addressing Cancer Together Intervention for Parents With Cancer

Study Overview
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Brief Summary
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The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence and ability to talk about their cancer with their minor children. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition.

Detailed Description
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Parents with cancer are encouraged to be honest and open with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way. The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.

Official Title
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Families Addressing Cancer Together (FACT): A Pilot Randomized Trial

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

Intervention / Treatment
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* Behavioral: FACT


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; Able to complete all study measures and visits in English; Be a parent (defined as biological, adoptive, foster, or step-parent), kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child age 3 to 17 years of age who can speak and understand English; Have a diagnosis of Stage II-IV (or equivalent) invasive solid tumor not in surveillance or survivorship Exclusion Criteria: Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes; Prior participation in the pilot trial or development and user testing protocol preliminary to this study; No current or expected contact with their child; or Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FACT intervention<br>Families Addressing Cancer Together (FACT) intervention plus questionnaires | Behavioral: FACT<br>* Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.<br>|
| No Intervention: Wait-list control condition<br>Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability as measured by FACT satisfaction scale | Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction. | 3 weeks | 
| Acceptability as measured by FACT satisfaction scale | Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction. | 6 weeks | 
| Acceptability as assessed by a semi-structured, post-intervention interview | Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews and analyzed via content analysis. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment feasibility as measured by percentage of eligible patients who consent to study participation | Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study. | 6 weeks | 
| Feasibility of participant retention as measured by percentage of participants who complete survey assessments at 3 weeks. | Percentage of enrolled participants who complete at least one study survey (any) at the 3-week time point. | 3 weeks | 
| Feasibility of participant retention as measured by percentage of participants who complete survey assessments at 6 weeks. | Percentage of enrolled participants who complete at least one study survey (any) at the 6-week time point. | 6 weeks | 
| Change from baseline communication self-efficacy using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Baseline, 3 weeks | 
| Change from baseline communication self-efficacy using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Baseline, 6 weeks |