NCT05268315

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

February 2, 2022

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    immediately post-intervention (day 1)

Study Arms (1)

Brief Psychoeducational Intervention

EXPERIMENTAL

Parents of children with cancer who complete the study participate in a brief, 1-session psychoeducational intervention.

Behavioral: Brief Psychoeducational Intervention

Interventions

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.

Brief Psychoeducational Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • parent(s) or legal guardian(s) of children with cancer
  • preferred language for oral and written communication is English
  • years of age or older
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Eric Zimak, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 7, 2022

Study Start

February 24, 2021

Primary Completion

June 28, 2022

Study Completion

June 28, 2022

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available.

Locations