Conexiones
Behavioral5 Conexiones telephone sessions
NCT Number: NCT03951454
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.
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Notify Me18 year–60 year
Female
Interventional
Not applicable
Memorial Medical Center-Cancer Center, Las Cruces, New Mexico, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 Conexiones telephone sessions
1 Taking Time telephone session
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
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)
Time frame: 1 hour
Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so)
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)
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)
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)
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)
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)
Time frame: 1 hour
13 items assessing COVID 19 specific distress among cancer patients/survivors; participants respond on a 5 point Likert type scale (1-Strongly Disagree; 5- Strongly Agree)
Time frame: 1 hour
4 items assess COVID-19 related health care disruptions and concerns among cancer patients/survivors; participants respond on a 5 point Likert type scale (1-Strongly Disagree; 5- Strongly Agree)
Time frame: 1 hour
6 items assess COVID-19 related disruption to daily activities & social interactions among cancer patients/survivors; participants respond on a 5 point Likert type scale (1-Strongly Disagree; 5- Strongly Agree)
Time frame: 1 hour
5 items assess COVID-19 related financial hardships among cancer patients/survivors; participants respond on a 5 point Likert type scale (1-Strongly Disagree; 5- Strongly Agree)
New Mexico State University
Other
Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
Acronym: TTTC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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