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

New Mexico State University

Status

Completed

Conditions

Cancer Survivorship

Treatments

Behavioral: Conexiones

Behavioral: Taking Time

Study type

Interventional

Funder types

Other

Identifiers

NCT03951454

17894

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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