Cancer, Communication, Neoplasms, Parent-Child Relations, Parenting, Parents
Conditions
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALFACT
Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Biostatistician
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Families Addressing Cancer Together (FACT) Satisfaction Scale | 3 weeks | 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. |
| Acceptability as Measured by FACT Satisfaction Scale | 6 weeks | 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. |
| Acceptability as Assessed by a Semi-structured, Post-intervention Interview | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation | 6 weeks | Percentage of approached patients who meet study eligibility criteria who enroll (provide informed consent) in the study. |
| Change From Baseline Communication Self-efficacy Using the CSES | Baseline, 3 weeks | 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. |
| Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey | 3 weeks | Feasibility of participant retention as measured by the percentage of participants who complete at least one study survey, at the 3-week time point. |
| Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. | 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, |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 07/05/2022 through 02/22/2023 at one cancer center in North Carolina.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Weeks | Lost to Follow-up | 2 | 4 |
| 3 Weeks | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | FACT Intervention | Wait-list Control Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 21 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 24 participants | 23 participants | 47 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Yes | 11 Participants |
| Families Addressing Cancer Together (FACT) Intervention | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Not reported | 1 Participants |
| Families Addressing Cancer Together (FACT) Intervention | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | No | 0 Participants |
| Beneficial | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Yes | 11 Participants |
| Beneficial | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Not reported | 1 Participants |
| Beneficial | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | No | 0 Participants |
| Recommended | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | No | 5 Participants |
| Recommended | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Yes | 7 Participants |
| Recommended | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Not reported | 0 Participants |
| Shortcomings | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Yes | 4 Participants |
| Shortcomings | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | Not reported | 0 Participants |
| Shortcomings | Acceptability as Assessed by a Semi-structured, Post-intervention Interview | No | 8 Participants |
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.
Time frame: 6 weeks
Population: Subjects joined to the study and completed satisfaction survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Acceptability as Measured by FACT Satisfaction Scale | 13.15 score on a scale | Standard Deviation 1.83 |
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.
Time frame: 3 weeks
Population: Participants who started the intervention and completed the post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Families Addressing Cancer Together (FACT) Satisfaction Scale | 16.24 score on a scale | Standard Deviation 2.48 |
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.
Time frame: Baseline, 6 weeks
Population: Subjects who joined to the study and completed the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Change From Baseline Communication Self-efficacy Using the CSES | 9.47 score on a scale | Standard Deviation 16.08 |
| Beneficial | Change From Baseline Communication Self-efficacy Using the CSES | 0.96 score on a scale | Standard Deviation 14.1 |
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.
Time frame: Baseline, 3 weeks
Population: Participants who started the study and completed the post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Change From Baseline Communication Self-efficacy Using the CSES | 6.46 score on a scale | Standard Deviation 14.4 |
| Beneficial | Change From Baseline Communication Self-efficacy Using the CSES | 2.85 score on a scale | Standard Deviation 9.28 |
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.
Time frame: 3 weeks
Population: Participants who started the study and completed the post-intervention survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey | 21 Participants |
| Beneficial | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey | 18 Participants |
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,
Time frame: 6 weeks
Population: Subjects joined to the study and completed the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. | 23 Participants |
| Beneficial | Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks. | 17 Participants |
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.
Time frame: 6 weeks
Population: All participants were invited to the study including both arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Families Addressing Cancer Together (FACT) Intervention | Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation | Number of Eligible Participants for Screening | 93 Participants |
| Families Addressing Cancer Together (FACT) Intervention | Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation | Number of Participants Consented and Started | 47 Participants |