NCT05840263 · University of Colorado, Denver
Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations