Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
NCT ID: NCT05840263
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
48 participants
OBSERVATIONAL
2023-05-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Metastatic Colorectal Cancer Patients
We anticipate enrolling up to a total of 18 patients who have been diagnosed with metastatic colorectal cancer; 12 patients will participate in the qualitative interview, and 6 patients will participate in the cognitive interview.
Qualitative interview
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.
Cognitive Interviews
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.
Metastatic Colorectal Cancer Patients Partners
We anticipate enrolling up to a total of 18 partners of patients who have been diagnosed with metastatic colorectal cancer; 12 partners will participate in the qualitative interview, and 6 paartners will participate in the cognitive interview.
Qualitative interview
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.
Cognitive Interviews
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.
Clinicians
We anticipate enrolling 12 clinicians (including physicians, nurse practitioners, physician assistants, mental health providers, other advanced practice clinicians) who treat patients with colorectal cancer at the University of Colorado to participate in qualitative interviews. We seek to enroll a variety of clinicians from advanced practiced clinical roles (physicians, nurse practitioners, and mental health providers) to capture diverse perspectives.
Qualitative interview
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.
Interventions
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Qualitative interview
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.
Cognitive Interviews
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
85 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Lauren Zimmaro
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Cancer Center
Aurora, Colorado, United States
Countries
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Central Contacts
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Other Identifiers
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22-2246.cc
Identifier Type: -
Identifier Source: org_study_id
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