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

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ClinicalTrials.gov Identifier: NCT03951454
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
University of Washington
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Rebecca Palacios, New Mexico State University

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.

Condition or disease Intervention/treatment Phase
Cancer Survivorship Behavioral: Conexiones Behavioral: Taking Time Not Applicable

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 counties of Doña Ana, New Mexico and El Paso, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participants are not informed as to whether they are in the experimental intervention or the control intervention.

Members of the Data Collection Team at New Mexico State University (NMSU) remain "blind" on the randomization status of study participants. Randomization will be handled centrally by the team's biostatistician, Griffith, at the University of Washington. She will be responsible for centralized random assignment using block randomization [by recruitment sites, language of program delivery, and cancer types] and will communicate that assignment only to Palacios, Lewis and the Project Manager.

Primary Purpose: Other
Official Title: Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Conexiones
5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks
Behavioral: Conexiones
5 Conexiones telephone sessions

Taking Time
1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet.
Behavioral: Taking Time
1 Taking Time telephone session




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only mothers diagnosed with cancer may participate in the trial.
Accepts Healthy Volunteers:   No
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 Doña Ana County, NM or El Paso County, TX
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951454


Locations
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United States, New Mexico
New Mexico State University
Las Cruces, New Mexico, United States, 88003
Memorial Medical Center - Family Medicine Center
Las Cruces, New Mexico, United States, 88011
Memorial Medical Center-Cancer Center
Las Cruces, New Mexico, United States, 88011
Sponsors and Collaborators
New Mexico State University
University of Washington
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Rebecca Palacios, PhD New Mexico State University
Principal Investigator: Frances M Lewis, PhD University of Washington, Fred Hutchinson Cancer Research Center

Additional Information:
Publications:
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Responsible Party: Rebecca Palacios, Associate Professor, New Mexico State University
ClinicalTrials.gov Identifier: NCT03951454     History of Changes
Other Study ID Numbers: 17894
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 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.
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Palacios, New Mexico State University:
maternal
non-metastatic
anxiety
depression