Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Survivorship
- Sponsor
- New Mexico State University
- Enrollment
- 43
- Locations
- 5
- Primary Endpoint
- Child Behavior Checklist (CBCL)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 (e.g. 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 materials/delivery 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 0.52 for the primary outcome measure of the child's behavioral-emotional adjustment, the investigators need to retain a total sample size of 116 (58/group) 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.
Investigators
Rebecca Palacios
Associate Professor
New Mexico State University
Eligibility Criteria
Inclusion Criteria
- •Hispanic women
- •Diagnosed with primary, non-metastatic cancer (stage 0, I, II, or III) of any type in the past 2 years
- •Has a child 5 to 17 years old living at home and who knows about their mother's cancer
- •Lives in New Mexico or Texas
- •Has ready access to a telephone
- •Can read and write in English or Spanish
Exclusion Criteria
- •Has a secondary and/or recurrent cancer diagnosis
- •Diagnosed with basal or squamous cell carcinoma
- •Not able to read or write in English or Spanish
- •Does not have ready access to a telephone
- •Her child is not aware of the mother's cancer diagnosis
- •Her child has learning challenges that would prevent him/her from engaging in a conversation with their mother
Outcomes
Primary Outcomes
Child Behavior Checklist (CBCL)
Time Frame: 3 months
A mother-reported scale of a broad range of behavior problems in children ages 6-18; Response options range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True
Secondary Outcomes
- Parenting Skills Checklist(1 hour)
- Center for Epidemiological Studies-Depression Scale (CES-D)(7 days)
- Cancer Self-Efficacy Scale (CASE)(1 hour)
- Family-Peer Relationship Scale (FPRQ)(3 months)
- Spielberger State-Trait Anxiety Inventory (STAI)(1 hour)