Cancer SurvivorshipTTTCNCT03951454
Taking Time to Connect: A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children
A study testing Conexiones and Taking Time in people with Cancer Survivorship, run by New Mexico State University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Conexiones and Taking Time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Apr 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Hospitals of Providence
El Paso, Texas, 79911
University Medical Center of El Paso
El Paso, Texas, 79912
New Mexico State University
Las Cruces, New Mexico, 88003
Memorial Medical Center-Cancer Center
Las Cruces, New Mexico, 88011
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
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.
Read the 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.
- Conditions
- Cancer Survivorship
- Being tested
- Conexiones, Taking Time
- Keywords
- maternal, non-metastatic, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConexionesBehavioural
5 Conexiones telephone sessions
Taking TimeBehavioural
1 Taking Time telephone session
| Study group | Role | What they receive |
|---|---|---|
| Conexiones | Experimental | 5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks Receives: Behavioral: Conexiones |
| Taking Time | Other | 1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet. Receives: Behavioral: Taking Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
Center for Epidemiological Studies-Depression Scale (CES-D)
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)
Measured: 7 days
Spielberger State-Trait Anxiety Inventory (STAI)
Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so)
Measured: 1 hour
Cancer Self-Efficacy Scale (CASE)
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)
Measured: 1 hour
Family-Peer Relationship Scale (FPRQ)
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)
Measured: 3 months
Parenting Skills Checklist
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start16 Apr 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Rebecca Palacios, New Mexico State University
- Investigators
- Rebecca Palacios, PhD, Principal investigator, New Mexico State UniversityFrances M Lewis, PhD, Principal investigator, University of Washington, Fred Hutchinson Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951454
- Sponsor's protocol ID
- 17894
- Acronym
- TTTC
- Status last verified
- Feb 2023
- First submitted
- 13 May 2019
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 16216035
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT03951454
- Acronym / sponsor ID
- TTTC / 17894
- Conditions
- Cancer Survivorship
- Keywords
- maternal, non-metastatic, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- New Mexico State UniversityUniversity, hospital or other
- Collaborators
- University of Washington, Fred Hutchinson Cancer Center
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conexiones | Experimental | Behavioral: Conexiones5 telephone sessions of Conexiones, with each session delivered 2 weeks apart across a total period of 8 weeks |
| Taking Time | Other | Behavioral: Taking Time1 telephone session consisting of a scripted protocol guiding participants through the NCI's Taking Time Booklet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conexiones5 Conexiones telephone sessions | Behavioural | Conexiones |
| Taking Time1 Taking Time telephone session | Behavioural | Taking Time |
Primary outcome
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
5 secondary outcomes
Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: 7 days
Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: 1 hour
Cancer Self-Efficacy Scale (CASE)
Time frame: 1 hour
Family-Peer Relationship Scale (FPRQ)
Time frame: 3 months
Parenting Skills Checklist
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 16216035Lewis 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.
- Complementary and Alternative Medicine QuestionnaireLink provided by the sponsor.
- Center for Epidemiologic Studies - Depression Scale (CES-D)Link provided by the sponsor.
- Child Behavior Checklist for Ages 6-18Link provided by the sponsor.
- Brief COPE InventoryLink provided by the sponsor.
- COVID-19: Impact of the Pandemic and HRQoL in Cancer Patients and Survivors (IPHCPS)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Palacios, PhD principal investigator
New Mexico State University
Frances M Lewis, PhD principal investigator
University of Washington, Fred Hutchinson Cancer Research Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conexiones and Taking Time in people with Cancer Survivorship, run by New Mexico State University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behavior Checklist (CBCL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023; AzTrials last refreshed its copy on 2 Nov 2026.