NCT05840263 Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
| NCT ID | NCT05840263 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Metastatic Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2023-05-31 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners.
Eligibility Criteria
Patient Inclusion Criteria: * Provision to sign and date the consent form. * Stated willingness to comply with all study procedures and be available for the duration of the study. * Be aged \> 18 years. * Fluent in English language * Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC), a partner (e.g., spouse) of someone diagnosed with mCRC, or a clinician who treats patients diagnosed with mCRC. Additional patient participant inclusion criteria: * Has a current diagnosis of metastatic (Stage IV, recurrent) colorectal cancer * Has an ECOG status \<2 or otherwise deemed appropriate for study participation by a clinician * Is in a committed relationship with a romantic partner for \>6 months * Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer) * Indicates a score \>0 on the Distress Thermometer Additional partner participant inclusion criteria: * Has been in a committed relationship \>6 months with a patient who meets the above eligibility criteria * Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer) * Indicates a score \>0 on the Distress Thermometer Additional clinician participant inclusion criteria: ∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.) Exclusion Criteria: ∙Has a serious mental illness (e.g., psychotic disorder), cognitive impairment (e.g., dementia), or medical condition (e.g., significant impaired sight/hearing) that would compromise participation
Contact & Investigator
Lauren Zimmaro
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05840263 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05840263 currently recruiting?
Yes, NCT05840263 is actively recruiting participants. Contact the research team at kaylee.ortega@cuanschutz.edu for enrollment information.
Where is the NCT05840263 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05840263 clinical trial?
NCT05840263 is sponsored by University of Colorado, Denver. The principal investigator is Lauren Zimmaro at University of Colorado, Denver. The trial plans to enroll 48 participants.
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