NeoplasmsFACTNCT05377749
The Families Addressing Cancer Together Intervention for Parents With Cancer
A study testing FACT in people with Neoplasms and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- FACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 22 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Families Addressing Cancer Together (FACT): A Pilot Randomized Trial
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.
Read the 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.
- Conditions
- Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations
- Being tested
- FACT
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACTBehavioural
Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
| Study group | Role | What they receive |
|---|---|---|
| FACT intervention | Experimental | Families Addressing Cancer Together (FACT) intervention plus questionnaires Receives: Behavioral: FACT |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks
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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start5 Jul 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zev M Nakamura, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377749
- Sponsor's protocol ID
- LCCC2150
- Other IDs
- 5K07CA218167
- Acronym
- FACT
- Status last verified
- May 2024
- First submitted
- 20 Apr 2022
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Addressing Cancer Together (FACT): A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05377749
- Acronym / sponsor ID
- FACT / LCCC2150
- Conditions
- Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FACT intervention | Experimental | Behavioral: FACTFamilies Addressing Cancer Together (FACT) intervention plus questionnaires |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACTFamilies Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer. | Behavioural | FACT intervention |
Primary outcome
Families Addressing Cancer Together (FACT) Satisfaction Scale
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Recruitment Feasibility as Measured by Rate of Eligible Patients Who Consent to Study Participation
Time frame: 6 weeks
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey
Time frame: 3 weeks
Feasibility of Participant Retention as Measured by Percentage of Participants Who Complete Survey Assessments at 6 Weeks.
Time frame: 6 weeks
Change From Baseline Communication Self-efficacy Using the CSES
Time frame: Baseline, 3 weeks
Change From Baseline Communication Self-efficacy Using the CSES
Time frame: Baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev M Nakamura, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACT in people with Neoplasms and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Families Addressing Cancer Together (FACT) Satisfaction Scale (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.