A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Acceptability of the Intervention Assessed Via Semi-structured Interviews
- Status
- Completed
- Last Updated
- last year
Overview
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.
Detailed Description
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
Secondary Outcomes
- Feasibility of Screening(Baseline)
- Feasibility of Recruitment(Baseline)
- Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale(Baseline, 14 days, 84 days)