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| ID | Type | Description | Link |
|---|---|---|---|
| 5K07CA218167 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
Parents with cancer are encouraged to be "honest and open" with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way.
The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. 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. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACT intervention | Experimental | Families Addressing Cancer Together (FACT) intervention plus questionnaires |
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| Wait-list control condition | No Intervention | Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACT | Behavioral | Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Families Addressing Cancer Together (FACT) Satisfaction Scale | Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction. | 3 weeks |
| Acceptability as Measured by FACT Satisfaction Scale | Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction. | 6 weeks |
| Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews. Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation | Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study. | 6 weeks |
| Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zev M Nakamura, 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 |
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During this period, there have been 93 potential subjects who could be approached for screening. In total 47 subjects were found eligible for the study and started.
Participants were recruited from 07/05/2022 through 02/22/2023 at one cancer center in North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Families Addressing Cancer Together (FACT) Intervention | Families Addressing Cancer Together (FACT) intervention plus questionnaires FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer. |
| FG001 | Wait-list Control Condition | Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessments |
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| 3 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | FACT Intervention | Families Addressing Cancer Together (FACT) intervention plus questionnaires FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer. |
| BG001 | Wait-list Control Condition |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Families Addressing Cancer Together (FACT) Satisfaction Scale | Acceptability was measured by the FACT satisfaction scale in the intervention group using the study-specific, 6-item FACT satisfaction scale. The total score range is 0-18 with higher scores indicating more satisfaction. | Participants who started the intervention and completed the post-intervention survey. | Posted | Mean | Standard Deviation | score on a scale | 3 weeks |
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Not available. The protocol does not require adverse event assessment.
The protocol does not require adverse event assessment. Adverse Event Data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FACT Intervention | Families Addressing Cancer Together (FACT) intervention plus questionnaires FACT: Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zev Nakamura, MD | University of North Carolina Lineberger Comprehensive Cancer Center | (984) 974-3829 | zev_nakamura@med.unc.edu |
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| 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 | Mar 31, 2023 | Jan 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Biostatistician
Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point. |
| 3 weeks |
| Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. | Percentage of enrolled participants who complete at least one study survey (any) at the 6-week time point.The number of participants who completed the assessment, | 6 weeks |
| Change From Baseline Communication Self-efficacy Using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Baseline, 3 weeks |
| Change From Baseline Communication Self-efficacy Using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Baseline, 6 weeks |
| NOT COMPLETED |
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Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Acceptability as Measured by FACT Satisfaction Scale | Satisfaction with FACT will be measured in the intervention group using the study-specific, 6-item FACT satisfaction scale. Total score range is 0-18 with higher scores indicating more satisfaction. | Subjects joined to the study and completed satisfaction survey. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
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| Primary | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Satisfaction with FACT will be assessed via semi-structured, post-intervention interviews. Regarding n's, these interviews were offered as an optional part of participation among those randomized to the intervention (FACT). 12 participants agreed to participate in the interviews. | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| Secondary | Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation | Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study. | All participants were invited to the study including both arms. | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| Secondary | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey | Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point. | Participants who started the study and completed the post-intervention survey. | Posted | Count of Participants | Participants | 3 weeks |
|
|
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| Secondary | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. | Percentage of enrolled participants who complete at least one study survey (any) at the 6-week time point.The number of participants who completed the assessment, | Subjects joined to the study and completed the assessment. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Change From Baseline Communication Self-efficacy Using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Participants who started the study and completed the post-intervention survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 weeks |
|
|
|
| Secondary | Change From Baseline Communication Self-efficacy Using the CSES | Change in parental communication self-efficacy will be measured using an adapted version of the Communication Self-Efficacy Scale (CSES). The 9-item CSES measures parental communication self-efficacy on a visual analogue scale, with a total score range of 0 to 100, with higher scores meaning more self-efficacy. | Subjects who joined to the study and completed the assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Wait-list Control Condition | Participants assigned to the waitlist control condition only complete questionnaires during the study period. After they have completed their 6-week study activities, they will receive access to the FACT intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| No |
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| Not reported |
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