NCT03951454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

May 13, 2019

Last Update Submit

February 21, 2023

Conditions

Cancer Survivorship

Keywords

maternalnon-metastaticanxietydepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Center for Epidemiological Studies-Depression Scale (CES-D)

    7 days

  • Spielberger State-Trait Anxiety Inventory (STAI)

    1 hour

  • Cancer Self-Efficacy Scale (CASE)

    1 hour

  • Family-Peer Relationship Scale (FPRQ)

    3 months

  • Parenting Skills Checklist

    1 hour

Other Outcomes (6)

  • Social Support Survey Instrument

    3 months

  • Brief Cope

    3 months

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

    1 hour

  • +3 more other outcomes

Study Arms (2)

Conexiones

EXPERIMENTAL

5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks

Behavioral: Conexiones

Taking Time

OTHER

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

Behavioral: Taking Time

Interventions

ConexionesBEHAVIORAL

5 Conexiones telephone sessions

Conexiones
Taking TimeBEHAVIORAL

1 Taking Time telephone session

Taking Time

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly mothers diagnosed with cancer may participate in the trial.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

New Mexico State University

Las Cruces, New Mexico, 88003, United States

Location

Memorial Medical Center-Cancer Center

Las Cruces, New Mexico, 88011, United States

Location

The Hospitals of Providence

El Paso, Texas, 79911, United States

Location

University Medical Center of El Paso

El Paso, Texas, 79912, United States

Location

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related 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.

    PMID: 16216035BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Rebecca Palacios, PhD

    New Mexico State University

    PRINCIPAL INVESTIGATOR

  • Frances M Lewis, PhD

    University of Washington, Fred Hutchinson Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

April 16, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

US(5)