An interventional study of FACT in Neoplasms, Cancer and Parenting, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 53 is close to the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 424 studies on the registry; 96 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive access to intervention materials.
Behavioral: FACT
Customized communication guidance to help parents with cancer talk about their cancer with their children.
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
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
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
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
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
Feasibility of Screening
The number of subjects who were screened, recruited, and retained in the study were reported.
Time frame: Baseline
Feasibility of Recruitment
Number of patients who enroll in the study
Time frame: 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.
Time frame: Baseline, 14 days, 84 days
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.
| Milestone | FACT |
|---|---|
| Started | 53 |
| Completed | 29 |
| Not completed | 24 |
| Withdrew: Death | 4 |
| Withdrew: Clinical deterioration/illness progression | 2 |
| Withdrew: Did not complete baseline assessments | 5 |
| Withdrew: Lost to follow-up | 13 |
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 | FACT Was Helpful |
|---|---|
| Yes | 26 |
| No | 3 |
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.
| Participants | FACT |
|---|---|
| Intervention was satisfactory | 10 |
| Intervention was not satisfactory | 0 |
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 | FACT Was Useful |
|---|---|
| Yes | 26 |
| No | 3 |
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 | FACT Was Helpful |
|---|---|
| Yes | 27 |
| No | 2 |
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 | FACT Was Helpful |
|---|---|
| Yes | 27 |
| No | 2 |
The number of subjects who were screened, recruited, and retained in the study were reported.
| Participants | FACT |
|---|---|
| Screened | 69 |
| Recruited/consented | 53 |
| Completed baseline intervention | 46 |
| Completed 2-week intervention | 35 |
| Completed 12-week intervention | 29 |
Number of patients who enroll in the study
| Participants | FACT |
|---|---|
| Number who consented for participation | 53 |
| Number who completed baseline assessments to receive intervention | 46 |
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.
| score on a scale | Baseline | 14 Days | 84 Days |
|---|---|---|---|
| Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale | 78.8 ± 20.6 | 82.8 ± 20.2 | 82.8 ± 23.5 |
Collected over Through study completion, an average of six months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FACT | 4/53 (7.5%) | 0/53 (0%) | 0/53 (0%) |
Includes participants who provided informed consent and completed baseline assessments
| Age, Continuous(years) | FACT |
|---|---|
| Mean | 45.87 ± 7.14 |
| Sex: Female, Male(Participants) | FACT |
|---|---|
| Female | 35 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | FACT |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 51 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | FACT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 39 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNC Lineberger Comprehensive Cancer Center →