Cancer Survivorship Clinical Trial
— TTTCOfficial title:
Taking Time to Connect: A Randomized Clinical Trial for Hispanic Mothers Diagnosed With Cancer
NCT number | NCT03951454 |
Other study ID # | 17894 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 16, 2019 |
Est. completion date | September 30, 2022 |
Verified date | February 2023 |
Source | New Mexico State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Hospitals of Providence | El Paso | Texas |
United States | University Medical Center of El Paso | El Paso | Texas |
United States | Memorial Medical Center-Cancer Center | Las Cruces | New Mexico |
United States | New Mexico State University | Las Cruces | New Mexico |
United States | Mays Cancer Center, UT Health San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
New Mexico State University | Fred Hutchinson Cancer Center, University of Washington |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Social Support Survey Instrument | Assesses emotional and informational support, 9 items; 5 point Likert type scale (0-none of the time; 4-all of the time) | 3 months | |
Other | Brief Cope | 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 months | |
Other | COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- COVID-19 Specific Distress Subscale | 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) | 1 hour | |
Other | COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Health Care Disruptions & Concerns Subscale | 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) | 1 hour | |
Other | COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences - Disruption to Daily Activities & Social Interactions Subscale | 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) | 1 hour | |
Other | COVID-19 Impact of the Pandemic in Cancer Patients and Survivors: Psychosocial & Practical Experiences- Financial Hardship Subscale | 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) | 1 hour | |
Primary | 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 | 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) | 7 days | |
Secondary | Spielberger State-Trait Anxiety Inventory (STAI) | Measures maternal anxiety; 20 items; 4 point Likert-type scale (1-Not at all; 4-Very much so) | 1 hour | |
Secondary | 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) | 1 hour | |
Secondary | 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) | 3 months | |
Secondary | 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) | 1 hour |
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