Title: Testing the Efficacy of the Culturally-Adapted Conexiones Program for Hispanic Mothers Diagnosed with Cancer Project Leaders: Rebecca Palacios, NMSU; Fran Lewis, Fred Hutch [The content of this Full Proposal is identical in the NMSU and Fred Hutch proposals] PROJECT SUMMARY/ABSTRACT 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 counties of Dona Ana, New Mexico and El Paso, Texas. Eligible women will be diagnosed within 8 months with non-advanced cancer and will be mothers of a child 5-17 years of age. Study participants will be recruited from medical providers, non-profit organizations, and multiple public channels in the recruitment counties. After completing signed informed consent and baseline measures, mothers will be randomized to an experimental or control group. The experimental group will receive 5 fully scripted telephone-delivered educational sessions every 2 weeks by specially trained patient educators. The control group will be mailed ?Taking Time,? a booklet from NCI that describes the importance of patients expressing their feelings, getting emotional support, and taking control over their illness by learning all they can from their medical team. The primary endpoint for efficacy will be assessed at 3 months post- baseline using Linear Mixed Models within an intent to treat analysis on standardized measures of behavioral- emotional adjustment of the child and diagnosed mother. The stability of changes will be assessed on 66% of the study sample 6 months post-baseline using both descriptive and inferential statistics. With an estimated Effect size of 0.52 for the primary outcome measure of the child?s behavioral-emotional adjustment, the retained sample at 3-months will be 116, 58 per group. A total of 155 eligible mothers will be enrolled based on 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.
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