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

Cancer Survivorship Clinical Trial

— TTTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951454
• Other study ID #: 17894
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: New Mexico State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivorship

Intervention

Behavioral:
• Conexiones
5 Conexiones telephone sessions
• Taking Time
1 Taking Time telephone session

Locations

Country	Name	City	State
United States	The Hospitals of Providence	El Paso	Texas
United States	University Medical Center of El Paso	El Paso	Texas
United States	Memorial Medical Center-Cancer Center	Las Cruces	New Mexico
United States	New Mexico State University	Las Cruces	New Mexico
United States	Mays Cancer Center, UT Health San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
New Mexico State University	Fred Hutchinson Cancer Center, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lewis FM, Casey SM, Brandt PA, Shands ME, Zahlis EH. The enhancing connections program: pilot study of a cognitive-behavioral intervention for mothers and children affected by breast cancer. Psychooncology. 2006 Jun;15(6):486-97. doi: 10.1002/pon.979. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	3 months
Other	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)	3 months
Other	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)	1 hour
Other	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)	1 hour
Other	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)	1 hour
Other	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)	1 hour
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Brief COPE Inventory
•   Center for Epidemiologic Studies - Depression Scale (CES-D)
•   Child Behavior Checklist for Ages 6-18
•   Complementary and Alternative Medicine Questionnaire
•   COVID-19: Impact of the Pandemic and HRQoL in Cancer Patients and Survivors (IPHCPS)
•   Social Support Survey Instrument- Emotional/informational support
•   Spielberger's State Trait Anxiety Inventory