N/A
Completed N=53
An Evaluation of the Families Addressing Cancer Together (FACT) Intervention
Neoplasms · Cancer · Parenting · Communication
Source: ClinicalTrials.gov NCT04342871 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful — 26; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful |
26; 3 | — |
| PRIMARY Acceptability of the Intervention Assessed Via Semi-structured Interviews |
10; 0 | — |
| PRIMARY Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful |
26; 3 | — |
| PRIMARY Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important |
27; 2 | — |
| PRIMARY Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction |
27; 2 | — |
| SECONDARY Feasibility of Screening |
69; 53; 46; 35; 29 | — |
| SECONDARY Feasibility of Recruitment |
53; 46 | — |
| SECONDARY Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale |
78.8; 82.8; 82.8 | 0.2 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04342871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.