Taking Time to Connect: A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer

Conditions
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Cancer Survivorship

Intervention / Treatment
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* Behavioral: Conexiones
* Behavioral: Taking Time


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: Experimental subjects will receive Conexiones, a program designed to help the cancer-diagnosed mother manage her child's cancer-related concerns by improving the mother's mood and anxiety and by equipping the mother with parenting and communication skills to assist the child in coping with the mother's cancer. The program involves 5 fully scripted telephone-delivered educational sessions delivered at 2-week intervals by patient educators. Control group: Control subjects will receive an informational booklet published by NCI called, Taking Time. The booklet contains information on ways to manage emotional issues, including the importance of sharing feelings about the cancer with a trusted adult confidant, learning all you can about your cancer in order to regain control and talking with medical providers, and dealing with a new self-image. This group receives one scripted telephone-delivered session guiding the mother on how to obtain the most from the booklet.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conexiones<br>5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks | Behavioral: Conexiones<br>* 5 Conexiones telephone sessions<br>|
| Other: Taking Time<br>1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet. | Behavioral: Taking Time<br>* 1 Taking Time telephone session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior Checklist (CBCL) | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies-Depression Scale (CES-D) | Measures maternal depressed mood; 15 items measured on a 4 point Likert-type scale (1 -Rarely or none of the time; 4-Most or all of the time) | 7 days | 
| Spielberger State-Trait Anxiety Inventory (STAI) | Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so) | 1 hour | 
| Cancer Self-Efficacy Scale (CASE) | Three subscales (Help Child, Deal & Manage, and Stay Calm) measure parenting self-efficacy; 28 items; 11 point Likert-type scale (0-not at all confident; 10-Very Confident) | 1 hour | 
| Family-Peer Relationship Scale (FPRQ) | Measures parenting quality using 7 items that assess interpersonal communication between the mother and child; includes 2 subscales (Disclosure of Negative Feelings and Disclosure of Bad Things Happening); 5 point Likert-type scale (0-Never talks about it; 4-Always talks about it) | 3 months | 
| Parenting Skills Checklist | Assesses the interactional behaviors mothers used to assist their child to disclose, discuss, and cope with the breast cancer; 2 subscales (Elicitation subscale, Connecting & Coping subscale); 8 items; 6 point Likert-type scale (0-Never; 5-All of the time) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal, non-metastatic, anxiety, depression