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Completed

NCT Number: NCT05377749

The Families Addressing Cancer Together Intervention for Parents With Cancer

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.

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Key information

Conditions

Neoplasms Behavior Cancer Communication Parent-Child Relations Parenting Parents

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FACT

Behavioral

Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.

Primary outcomes

  1. Families Addressing Cancer Together (FACT) Satisfaction Scale

    Time frame: 3 weeks

    Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction.

  2. Acceptability as Measured by FACT Satisfaction Scale

    Time frame: 6 weeks

    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. Acceptability as Assessed by a Semi-structured, Post-intervention Interview

    Time frame: 6 weeks

    Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews.

    Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews.

Secondary outcomes

  1. Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation

    Time frame: 6 weeks

    Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study.

  2. Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey

    Time frame: 3 weeks

    Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point.

  3. Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.

    Time frame: 6 weeks

    Percentage of enrolled participants who complete at least one study survey (any) at the 6-week time point.The number of participants who completed the assessment,

  4. Change From Baseline Communication Self-efficacy Using the CSES

    Time frame: Baseline, 3 weeks

    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.

  5. Change From Baseline Communication Self-efficacy Using the CSES

    Time frame: Baseline, 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: FACT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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