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Completed

NCT Number: NCT04342871

An Evaluation of the Families Addressing Cancer Together (FACT) Intervention

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.

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Key information

Age range

18 year and older

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, United States

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About this study

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.

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;
  • 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 malignancy within the past 6 months or have a solid tumor cancer diagnosis with disease that is either stage IV or equivalent;
  • 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.

Treatment and study plan

FACT

Behavioral

Customized communication guidance to help parents with cancer talk about their cancer with their children.

Primary outcomes

  1. Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful

    Time frame: 14 days

    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.

  2. Acceptability of the Intervention Assessed Via Semi-structured Interviews

    Time frame: 14 days

    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.

  3. Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful

    Time frame: 14 days

    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.

  4. Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important

    Time frame: 14 days

    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.

  5. Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction

    Time frame: 14 days

    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.

Secondary outcomes

  1. Feasibility of Screening

    Time frame: Baseline

    The number of subjects who were screened, recruited, and retained in the study were reported.

  2. Feasibility of Recruitment

    Time frame: Baseline

    Number of patients who enroll in the study

  3. Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale

    Time frame: Baseline, 14 days, 84 days

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention

Acronym: FACT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2020
Registry last updated
Aug 15, 2024

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

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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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