Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
University of Colorado, Denver
48 participants
May 31, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria14
- 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.
- 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
- 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
- ∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.)
Exclusion Criteria1
- ∙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
Interventions
Qualitative interviews will cover four main goals including: (1) key sources of distress in mCRC patients and partners; (2) perceptions of mindfulness, including benefits, definitions, and applications; (3) barriers and facilitators of participation (e.g. home-based and couple-based skills practice, enrollment); and (4) session format preferences, such as session length and frequency.
The objective of the cognitive interviews (60 minutes, led by the PI) is to ensure the comprehensibility and appropriateness of the drafted participant materials. Published guidelines note a sample size of 12 participants (6 mCRC couples) should be sufficient. Participants will be asked to read, review, and mark up the participant materials in order to identify sections that were difficult to understand. They will also be asked to test playing segments of the audio/video recordings to ensure ease of use. A semi-structured interview format will be used to elicit feedback, including a standard verbal survey assessing ease of reading the material, any difficulties experienced, and suggestions they have for improving the ease of material use. Information generated will be used to update materials as necessary.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05840263