N/A
Completed N=47
The Families Addressing Cancer Together Intervention for Parents With Cancer
Source: ClinicalTrials.gov NCT05377749 ↗Enrolled (actual)
47
Serious AEs
—
Results posted
Feb 2024
Primary outcomePrimary: Families Addressing Cancer Together (FACT) Satisfaction Scale — 16.24 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Families Addressing Cancer Together (FACT) Satisfaction Scale |
16.24 | — |
| PRIMARY Acceptability as Measured by FACT Satisfaction Scale |
13.15 | — |
| PRIMARY Acceptability as Assessed by a Semi-structured, Post-intervention Interview |
11; 11; 7; 4; 0; 0 | — |
| SECONDARY Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation |
93; 47 | — |
| SECONDARY Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey |
21; 18 | — |
| SECONDARY Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. |
23; 17 | — |
| SECONDARY Change From Baseline Communication Self-efficacy Using the CSES |
9.47; 0.96 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05377749). 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.