An interventional study of Conexiones and Taking Time in Cancer Survivorship, sponsored by New Mexico State University. Completed at 5 sites in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by New Mexico State University · Not applicable, Interventional, and Other
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.
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.
New Mexico State University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks
Behavioral: Conexiones
1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet.
Behavioral: Taking Time
5 Conexiones telephone sessions
1 Taking Time telephone session
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
Time frame: 3 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 hour
Social Support Survey Instrument
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
Brief Cope
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: 3 months
COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- COVID-19 Specific Distress Subscale
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
COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Health Care Disruptions & Concerns Subscale
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
COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Disruption to Daily Activities & Social Interactions Subscale
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
COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- Financial Hardship Subscale
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)
Time frame: 1 hour
Plan to share: Yes — Data obtained on all standardized measures at baseline and post intervention will be shared with investigators both internal and external to New Mexico State University, the University of Washington, and the Fred Hutchinson Cancer Research Center. Prior to sharing the data, Lewis (Co-PI) and Palacios (Co-PI) will request a detailed plan for data analysis, the choice of the study sample, and a rationale and significance for the proposal. Prior to releasing the data, the proposal will be reviewed by Lewis and Palacios. Access levels will be set to protect subject identification and unique identifiers linked to participant identity will be stripped, (i.e., data will be de-identified). Access will be made available as soon as the primary analyses are completed and accepted for publication in a professional journal and secondary analyses are completed by the team's investigators.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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New Mexico State University