Clinical trial NCT03951454: Taking Time to Connect: A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children
Official title: Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivorship
Keywords: maternal
non-metastatic
anxiety
depression
Lead sponsor: New Mexico State University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Fred Hutchinson Cancer Center
First posted: 2019-05-15
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: 3 months
Secondary outcomes:
measure: Center for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: 7 days
measure: Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: 1 hour
measure: Cancer Self-Efficacy Scale (CASE)
timeFrame: 1 hour
measure: Family-Peer Relationship Scale (FPRQ)
timeFrame: 3 months
measure: Parenting Skills Checklist
timeFrame: 1 hour
Other outcomes:
measure: Social Support Survey Instrument
timeFrame: 3 months
measure: Brief Cope
timeFrame: 3 months
measure: COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- COVID-19 Specific Distress Subscale
timeFrame: 1 hour
measure: COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Health Care Disruptions & Concerns Subscale
timeFrame: 1 hour
measure: COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Disruption to Daily Activities & Social Interactions Subscale
timeFrame: 1 hour
measure: COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- Financial Hardship Subscale
timeFrame: 1 hour
Locations:
city: Las Cruces
country: United States
facility: New Mexico State University
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center-Cancer Center
state: New Mexico
city: El Paso
country: United States
facility: The Hospitals of Providence
state: Texas
city: El Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: New Mexico State University
name: Rebecca Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington, Fred Hutchinson Cancer Research Center
name: Frances M Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.