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Completed

NCT Number: NCT03951454

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

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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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Medical Center-Cancer Center, Las Cruces, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conexiones

Behavioral

5 Conexiones telephone sessions

Taking Time

Behavioral

1 Taking Time telephone session

Primary outcomes

  1. Child Behavior Checklist (CBCL)

    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

Secondary outcomes

  1. Center for Epidemiological Studies-Depression Scale (CES-D)

    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)

  2. Spielberger State-Trait Anxiety Inventory (STAI)

    Time frame: 1 hour

    Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so)

  3. Cancer Self-Efficacy Scale (CASE)

    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)

  4. Family-Peer Relationship Scale (FPRQ)

    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)

  5. Parenting Skills Checklist

    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)

Other outcomes

  1. Social Support Survey Instrument

    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)

  2. Brief Cope

    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)

  3. COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- COVID-19 Specific Distress Subscale

    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)

  4. COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Health Care Disruptions & Concerns Subscale

    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)

  5. COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Disruption to Daily Activities & Social Interactions Subscale

    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)

  6. COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- Financial Hardship Subscale

    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)

Sponsors and collaborators

Lead sponsor

New Mexico State University

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • University of Washington

Registry information

Official study title

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

Acronym: TTTC

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 15, 2019
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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