Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03951454
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2019-05-13
Brief Title:
Taking Time to Connect A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children
Sponsor:
New Mexico State University
Organization:
New Mexico State University
Study Overview
Official Title:
Taking Time to Connect A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTTC
Brief Summary:
This NCI-funded randomized clinical trial RCT will test the short-term efficacy of Conexiones a culturally adapted cancer education program designed to help Hispanic mothers diagnosed with cancer and their children to cope with cancer
Detailed Description:
The purpose of the proposed study is to test the short-term efficacy of a cancer parenting education program for diagnosed child-rearing Hispanic mothers called Conexiones This program was culturally adapted from a parenting program previously tested for efficacy in a Phase III 6-state randomized clinical trial However the original program was tested on primarily non-Hispanic White NHW mothers with breast cancer The Conexiones program represents a culturally adapted version of the original parenting program and is now ready for testing with Hispanic mothers living in the Border States of New Mexico and Texas Eligible women will be diagnosed within the last 2 years with a primary non-advanced cancer stages 0-III of any type and will be mothers of a child 5-17 years of age Study participants will be recruited from medical providers local channels eg community health agencies Community Health Worker networks social media and through self-referral in the recruitment counties After completing signed informed consent and baseline measures mothers will be randomized to an experimental or control group All program materialsdelivery are available in English and Spanish All program education and data collection is conducted entirely by telephone so that the women can participate within the comfort of their homes and at times convenient for them The experimental group will receive 5 fully scripted telephone-delivered educational sessions every 2 weeks by specially trained patient educators The control group will receive Taking Time a NCI cancer education booklet and 1 scripted telephone-delivered session with a patient educator Assessments will occur at 3 months post-baseline for all participants and at 6 months post-baseline for 66 of participants Post-intervention measures consist of standardized questionnaires with well-established validity and reliability all available in Spanish Linear Mixed Models will be used to analyze outcomes within an intent to treat analysis With an estimated Effect size of 052 for the primary outcome measure of the childs behavioral-emotional adjustment the investigators need to retain a total sample size of 116 58group for efficacy analysis The investigators plan to enroll 156 eligible mothers allowing for an expected 25 attrition rate from all causes Study results will be essential as a next step in testing Conexiones with other Hispanic subgroups in a larger trial and readying the program for wider testing and dissemination to provider and non-profit organizations serving Hispanic parents with cancer throughout the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None