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

NCT04342871 | Completed Results DMC

• 1 other identifier: LCCC2030
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

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

  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.

  14 days

• Acceptability of the Intervention Assessed Via Semi-structured Interviews

  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.

  14 days

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

  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.

  14 days

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

  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.

  14 days

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

  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.

  14 days

Secondary Outcomes (3)

• Feasibility of Screening

  Baseline

• Feasibility of Recruitment

  Baseline

• Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale

  Baseline, 14 days, 84 days

Study Arms (1)

FACT

EXPERIMENTAL

Patients will receive access to intervention materials.

Behavioral: FACT

Interventions

FACT BEHAVIORAL

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

FACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (2)

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

Chapel Hill, North Carolina, 27599, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Park EM, Deal AM, Heiling HM, Jung A, Yopp JM, Bowers SM, Hanson LC, Song MK, Valle CG, Yi B, Cassidy A, Won H, Rosenstein DL. Families Addressing Cancer Together (FACT): feasibility and acceptability of a web-based psychosocial intervention for parents with cancer. Support Care Cancer. 2022 Oct;30(10):8301-8311. doi: 10.1007/s00520-022-07278-x. Epub 2022 Jul 13.

  PMID: 35831719 DERIVED

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Eliza Park
• Organization: UNC Lineberger

leeza_park@med.unc.edu

919-966-3494

Study Officials

• Eliza Park, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Because this is a pilot study, all participants will receive the same intervention and no blinding will take place

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 13, 2020
• Study Start: October 5, 2020
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)