Cancer, Communication, Neoplasms, Parent-Child Relations, Parenting, Parents
Conditions
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.
Interventions
BEHAVIORALFACT
Customized communication guidance to help parents with cancer talk about their cancer with their children.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Because this is a pilot study, all participants will receive the same intervention and no blinding will take place
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction | 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 Assessed Via Semi-structured Interviews | 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-FACT Was Useful | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | Baseline | Number of patients who enroll in the study |
| Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | Baseline, 14 days, 84 days | 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. |
| Feasibility of Screening | Baseline | The number of subjects who were screened, recruited, and retained in the study were reported. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All participants were assigned to receive the intervention after completing baseline assessments.
Participants by arm
| Arm | Count |
|---|---|
| FACT Patients will receive access to intervention materials.
FACT: Customized communication guidance to help parents with cancer talk about their cancer with their children. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinical deterioration/illness progression | 2 |
| Overall Study | Death | 4 |
| Overall Study | Did not complete baseline assessments | 5 |
| Overall Study | Lost to Follow-up | 13 |
Baseline characteristics
| Characteristic | FACT |
|---|---|
| Age, Continuous | 45.87 years STANDARD_DEVIATION 7.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
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.
Time frame: 14 days
Population: Individuals who received intervention materials and participated in semi-structured feedback interview
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Acceptability of the Intervention Assessed Via Semi-structured Interviews | Intervention was satisfactory | 10 Participants |
| FACT Was Helpful | Acceptability of the Intervention Assessed Via Semi-structured Interviews | Intervention was not satisfactory | 0 Participants |
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.
Time frame: 14 days
Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important | Yes | 27 Participants |
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important | No | 2 Participants |
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.
Time frame: 14 days
Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful | Yes | 26 Participants |
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful | No | 3 Participants |
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.
Time frame: 14 days
Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful | No | 3 Participants |
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful | Yes | 26 Participants |
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.
Time frame: 14 days
Population: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction | Yes | 27 Participants |
| FACT Was Helpful | Acceptability of the Intervention Measured by the Study Visit Satisfaction Form- Overall Satisfaction | No | 2 Participants |
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.
Time frame: Baseline, 14 days, 84 days
Population: Participants who completed the Communication self-efficacy scale at baseline, 14 days, and 84 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FACT Was Helpful | Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 78.8 score on a scale | Standard Deviation 20.6 |
| 14 Days | Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 82.8 score on a scale | Standard Deviation 20.2 |
| 84 Days | Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 82.8 score on a scale | Standard Deviation 23.5 |
p-value: 0.2t-test, 2 sided
Secondary
Feasibility of Recruitment
Number of patients who enroll in the study
Time frame: Baseline
Population: Number of individuals eligible for participation who enrolled in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Feasibility of Recruitment | Number who consented for participation | 53 Participants |
| FACT Was Helpful | Feasibility of Recruitment | Number who completed baseline assessments to receive intervention | 46 Participants |
Secondary
Feasibility of Screening
The number of subjects who were screened, recruited, and retained in the study were reported.
Time frame: Baseline
Population: Number of individuals who were assessed for eligibility and found to eligible
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FACT Was Helpful | Feasibility of Screening | Screened | 69 Participants |
| FACT Was Helpful | Feasibility of Screening | Recruited/consented | 53 Participants |
| FACT Was Helpful | Feasibility of Screening | Completed baseline intervention | 46 Participants |
| FACT Was Helpful | Feasibility of Screening | Completed 2-week intervention | 35 Participants |
| FACT Was Helpful | Feasibility of Screening | Completed 12-week intervention | 29 Participants |