Taking Time to Connect: A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children (TTTC)
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|ClinicalTrials.gov Identifier: NCT03951454|
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivorship||Behavioral: Conexiones Behavioral: Taking Time||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Outcomes Assessor)|
Participants are not informed as to whether they are in the experimental intervention or the control intervention.
Members of the Data Collection Team at New Mexico State University (NMSU) remain "blind" on the randomization status of study participants. Randomization will be handled centrally by the team's biostatistician, Griffith, at the University of Washington. She will be responsible for centralized random assignment using block randomization [by recruitment sites, language of program delivery, and cancer types] and will communicate that assignment only to Palacios, Lewis and the Project Manager.
|Official Title:||Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks
5 Conexiones telephone sessions
1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet.
Behavioral: Taking Time
1 Taking Time telephone session
- 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
- Center for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: 7 days ]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)
- Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: 1 hour ]Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so)
- Cancer Self-Efficacy Scale (CASE) [ Time Frame: 1 hour ]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)
- Family-Peer Relationship Scale (FPRQ) [ Time Frame: 3 months ]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)
- Parenting Skills Checklist [ Time Frame: 1 hour ]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)
- Social Support Survey Instrument [ Time Frame: 3 months ]Assesses emotional and informational support, 9 items; 5 point Likert type scale (0-none of the time; 4-all of the time)
- Brief Cope [ Time Frame: 3 months ]Measure of strategies used for coping or regulating cognitions in response to stressors; 28 items; 4 point Likert type scale (1-I didn't do this at all; 4-I did this a lot)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951454
|United States, New Mexico|
|New Mexico State University|
|Las Cruces, New Mexico, United States, 88003|
|Memorial Medical Center - Family Medicine Center|
|Las Cruces, New Mexico, United States, 88011|
|Memorial Medical Center-Cancer Center|
|Las Cruces, New Mexico, United States, 88011|
|Principal Investigator:||Rebecca Palacios, PhD||New Mexico State University|
|Principal Investigator:||Frances M Lewis, PhD||University of Washington, Fred Hutchinson Cancer Research Center|