Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
Recruiting · NCT07759921 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Couple-based Mindfulness InterventionHealth and Wellness Education Control Condition
What this trial is about
The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 to 85.
- Fluent in English language. All study materials, including the informed consent form, participant workbooks, and questionnaires, are currently available only in English. Participation requires the ability to independently read and engage with written study materials (including the participant workbook), which are integral to the intervention session content and home practices. Therefore, individuals who are unable to read study materials in English are not eligible to participate. At this time, the intervention has not been translated or validated in other languages, therefore participation is limited to individuals who can read, speak, and understand English to ensure that participants are able to fully engage with study activities.
- Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC) or a partner (e.g., spouse) of someone diagnosed with mCRC.
- Indicates a score \>0 on the Distress Thermometer
- Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
- Additional eligibility criteria include:
- 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. Monogamy is not required for eligibility; however, in cases of polyamorous relationships, the patient will designate a primary partner for participation in the study.
- Additional partner participant inclusion criteria:
- Has been in a committed relationship \>6 months with a patient who meets the above eligibility criteria
- Eligibility for relationship status will be self-reported by participants during recruitment.
Exclusion criteria
- One or both members of the couple has an active or poorly controlled 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.
- The couple is currently in active couples (e.g., marital) therapy together.
- Participants who are physically or mentally too ill to participate or those with major cognitive impairments are excluded because they may not be able to engage with intervention sessions, surveys. No exclusions will be made based on sexual orientation, race, gender, or other sociodemographic features. Because patients with mCRC are living longer, and patients and partners can experience distress at various times since their diagnosis, we do not limit participation by time since diagnosis.
Where it is running
1 location listed across 1 US state.
- University of Colorado Hospital - Aurora, Colorado, United States