Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACT | Experimental | Patients will receive access to intervention materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACT | Behavioral | Customized communication guidance to help parents with cancer talk about their cancer with their children. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Screening | The number of subjects who were screened, recruited, and retained in the study were reported. | Baseline |
| Feasibility of Recruitment | Number of patients who enroll in the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eliza Park, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35831719 | Derived | 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. |
| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All participants were assigned to receive the intervention after completing baseline assessments.
Subjects were recruited from October 2020 to April 2021 in one center in North Carolina. Although 53 participants consented, 5 subjects did not complete the baseline assessment, and 2 subjects' clinical conditions did not allow them to complete the study requirements. Forty -six participants received the baseline intervention, 35 out of 46 participants completed the 2-week intervention, and 29 out of 35 participants completed the 12-week intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FACT | Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes participants who provided informed consent and completed baseline assessments
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FACT | Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale | Posted | Count of Participants | Participants | 14 days |
|
Through study completion, an average of six months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FACT | Patients will receive access to intervention materials. FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliza Park | UNC Lineberger | 919-966-3494 | leeza_park@med.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2021 | Apr 18, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Because this is a pilot study, all participants will receive the same intervention and no blinding will take place
Not provided
Not provided
Not provided
Not provided
| 14 days |
| Baseline |
| Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 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. | Baseline, 14 days, 84 days |
| University of North Carolina Hospital |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Individuals who received intervention materials and participated in semi-structured feedback interview | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Primary | 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. | Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Primary | 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. | Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Primary | 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. | Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Feasibility of Screening | The number of subjects who were screened, recruited, and retained in the study were reported. | Number of individuals who were assessed for eligibility and found to eligible | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Feasibility of Recruitment | Number of patients who enroll in the study | Number of individuals eligible for participation who enrolled in the study. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 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. | Participants who completed the Communication self-efficacy scale at baseline, 14 days, and 84 days. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 14 days, 84 days |
|
|
|
|
| 4 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
Not provided
Not provided
| Title | Measurements |
|---|
|
| Completed 2-week intervention |
|
| Completed 12-week intervention |
|