NeoplasmsFACTNCT04342871

An Evaluation of the Families Addressing Cancer Together (FACT) Intervention

A study testing FACT in people with Neoplasms and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Cancer, Parenting
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: 53 participants
Where: 2 sitesUnited States
Study dates: 5 Oct 2020to 27 Jul 2021
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 years and older
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;
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.

Who cannot join

Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention

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.

Read the 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.

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
Customized communication guidance to help parents with cancer talk about their cancer with their children.

Study groups in NCT04342871
Study group	Role	What they receive
FACT	Experimental	Patients will receive access to intervention materials. Receives: Behavioral: FACT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days

Secondary outcomes (3)

Feasibility of Screening
The number of subjects who were screened, recruited, and retained in the study were reported.
Measured: Baseline
Feasibility of Recruitment
Number of patients who enroll in the study
Measured: 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.
Measured: Baseline, 14 days, 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202027 Jul 2021

First posted13 Apr 2020
Study start5 Oct 2020
Primary completion27 Jul 2021
Study completion27 Jul 2021

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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Model description: Because this is a pilot study, all participants will receive the same intervention and no blinding will take place
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04342871
Sponsor's protocol ID: LCCC2030
Acronym: FACT
Status last verified: Mar 2024
First submitted: 29 Mar 2020
Last updated: 15 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Park EM, Deal AM, Heiling HM, Jung A, Yopp JM, Bowers SM, Hanson LC, Song MK, Valle CG, Yi B, Cassidy A, Won H, Rosenstein DL. Families Addressing Cancer Together (FACT): feasibility and acceptability of a web-based psychosocial intervention for parents with cancer. Support Care Cancer. 2022 Oct;30(10):8301-8311. doi: 10.1007/s00520-022-07278-x. Epub 2022 Jul 13.
PubMed 35831719

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention
ClinicalTrials.gov ID: NCT04342871
Acronym / sponsor ID: FACT / LCCC2030
Conditions: Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
Study start: 5 Oct 2020 (actual)
Primary completion: 27 Jul 2021 (actual)
Study completion: 27 Jul 2021 (actual)
First posted: 13 Apr 2020 (actual)
Results: Posted 15 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Because this is a pilot study, all participants will receive the same intervention and no blinding will take place

Arm	Type	Receives
FACT	Experimental	Behavioral: FACTPatients will receive access to intervention materials.

Who may qualify

Ages: 18 years and older
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;
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;

Key exclusion criteria (1 listed)

Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.

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
FACTCustomized communication guidance to help parents with cancer talk about their cancer with their children.	Behavioural	FACT

Primary outcome

Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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- Overall Satisfaction
Time frame: 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.

3 secondary outcomes

Feasibility of Screening
Time frame: Baseline
Feasibility of Recruitment
Time frame: Baseline
Communication Self-efficacy Measured by the Adapted Communication Self-Efficacy Scale
Time frame: Baseline, 14 days, 84 days

Results and safety

Results posted to the registry on 15 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FACT	53	29

Primary outcome: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful

Time frame: 14 days. Count of participants. Unit: Participants

Measure	FACT Was Helpful n = 29
Yes	26
No	3

Population analysed: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Primary outcome: Acceptability of the Intervention Assessed Via Semi-structured Interviews

Time frame: 14 days. Count of participants. Unit: Participants

Measure	FACT n = 10
Intervention was satisfactory	10
Intervention was not satisfactory	0

Population analysed: Individuals who received intervention materials and participated in semi-structured feedback interview

Primary outcome: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form-FACT Was Useful

Time frame: 14 days. Count of participants. Unit: Participants

Measure	FACT Was Useful n = 29
Yes	26
No	3

Population analysed: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

Primary outcome: Acceptability of the Intervention Measured by the Study Visit Satisfaction Form Content Was Important

Time frame: 14 days. Count of participants. Unit: Participants

Measure	FACT Was Helpful n = 29
Yes	27
No	2

Population analysed: Participants who completed 2-week satisfaction assessment, reporting acceptability (Somewhat or very helpful) on 4-point scale

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of six months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FACT	0 of 53 (0%)	0 of 53 (0%)	4 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35831719Park EM, Deal AM, Heiling HM, Jung A, Yopp JM, Bowers SM, Hanson LC, Song MK, Valle CG, Yi B, Cassidy A, Won H, Rosenstein DL. Families Addressing Cancer Together (FACT): feasibility and acceptability of a web-based psychosocial intervention for parents with cancer. Support Care Cancer. 2022 Oct;30(10):8301-8311. doi: 10.1007/s00520-022-07278-x. Epub 2022 Jul 13.
UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
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.

Eliza Park, MD principal investigator

University of North Carolina, Chapel Hill

2 sites 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 2 sites 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 1 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 15 Aug 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?

Acceptability of the Intervention Measured by the Study Visit Satisfaction Form FACT Was Helpful (time frame: 14 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342871, which also lists 1 linked publication.

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 15 Aug 2024.