CancerNCT05268315
A Brief Parental Intervention on Learning and Education in Childhood Cancer
A study testing Brief Psychoeducational Intervention in people with Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Brief Psychoeducational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- parent(s) or legal guardian(s) of children with cancer
- preferred language for oral and written communication is English
- 18 years of age or older
- 1 or 2 parents or legal guardians can participate for each child
- The child must also meet the following for the parent(s)/legal guardian(s) to participate:
- diagnosis of cancer
Show all 10Show fewer
- child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
- child is between the age of 3 and 14
- child resides in New Mexico
- Exclusion Criteria: Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth \& Families Department).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
About this study
Official title: Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer
The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.
Read the detailed description
After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.
- Conditions
- Cancer
- Being tested
- Brief Psychoeducational Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Psychoeducational InterventionBehavioural
The 1-session psychoeducational intervention is divided into three brief modules. Topics that are covered include thinking, learning, emotional, and behavioral functioning as they relate to childhood cancer, educational and school supports, and the role of neuropsychological and school-based assessments.
| Study group | Role | What they receive |
|---|---|---|
| Brief Psychoeducational Intervention | Experimental | Parents of children with cancer who complete the study participate in a brief, 1-session psychoeducational intervention. Receives: Behavioral: Brief Psychoeducational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment and enrollment
Among qualifying families, the number receiving recruitment information about the study, identifying interest, scheduling, and completing procedures. Note, for each qualifying family, one or two parents or legal guardians are able to enroll in the study. This is a parental intervention and the child with cancer does not participate in the study.
Measured: Through study completion, up to 2 years
Fidelity to the intervention protocol
Interventions are audio-recorded. Percent adherence to the intervention protocol per a fidelity form, developed for this study, is assessed by an independent rater of fidelity.
Measured: at time of intervention (day 1)
Acceptability of the intervention
Ratings are provided on intervention acceptability as part of the Program Evaluation Form, a questionnaire developed for this study.
Measured: immediately post-intervention (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start24 Feb 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Responsible party
- Principal investigator, Eric Zimak, University of New Mexico
- Investigators
- Eric Zimak, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268315
- Sponsor's protocol ID
- 20-224
- Status last verified
- Jul 2024
- First submitted
- 2 Feb 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
Zimak EH, Davis L, Quattlebaum JA, Madrid J, Cruickshank A. Feasibility and Acceptability of a Brief Psychoeducational Intervention for Parents of Children with Childhood Cancer. Pediatr Blood Cancer. 2026 Jul;73(7):e70298. doi: 10.1002/1545-5017.70298. Epub 2026 Apr 30.
PubMed 42063258
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer
- ClinicalTrials.gov ID
- NCT05268315
- Acronym / sponsor ID
- 20-224
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.
Detailed description
After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Psychoeducational Intervention | Experimental | Behavioral: Brief Psychoeducational InterventionParents of children with cancer who complete the study participate in a brief, 1-session psychoeducational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- parent(s) or legal guardian(s) of children with cancer
- preferred language for oral and written communication is English
- 18 years of age or older
- 1 or 2 parents or legal guardians can participate for each child
- The child must also meet the following for the parent(s)/legal guardian(s) to participate:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Brief Psychoeducational InterventionThe 1-session psychoeducational intervention is divided into three brief modules. Topics that are covered include thinking, learning, emotional, and behavioral functioning as they relate to childhood cancer, educational and school supports, and the role of neuropsychological and school-based assessments. | Behavioural | Brief Psychoeducational Intervention |
Primary outcome
Feasibility of study recruitment and enrollment
Time frame: Through study completion, up to 2 years
Among qualifying families, the number receiving recruitment information about the study, identifying interest, scheduling, and completing procedures. Note, for each qualifying family, one or two parents or legal guardians are able to enroll in the study. This is a parental intervention and the child with cancer does not participate in the study.
Fidelity to the intervention protocol
Time frame: at time of intervention (day 1)
Interventions are audio-recorded. Percent adherence to the intervention protocol per a fidelity form, developed for this study, is assessed by an independent rater of fidelity.
Acceptability of the intervention
Time frame: immediately post-intervention (day 1)
Ratings are provided on intervention acceptability as part of the Program Evaluation Form, a questionnaire developed for this study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 42063258Zimak EH, Davis L, Quattlebaum JA, Madrid J, Cruickshank A. Feasibility and Acceptability of a Brief Psychoeducational Intervention for Parents of Children with Childhood Cancer. Pediatr Blood Cancer. 2026 Jul;73(7):e70298. doi: 10.1002/1545-5017.70298. Epub 2026 Apr 30.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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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.
Eric Zimak, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Psychoeducational Intervention in people with Cancer, run by University of New Mexico 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 10 inclusion and 0 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 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of study recruitment and enrollment (time frame: Through study completion, up to 2 years). 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?
On the ClinicalTrials.gov record for NCT05268315, 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 Jul 2024.