Metastatic Colorectal Cancer
Conditions
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.
Detailed 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. The intervention is named "MIND-Together" (Mindfully Navigating Distress Together). MIND-Together will be the first mindfulness-based intervention designed to reduce mCRC couples' distress by targeting their unique psychosocial needs. The intervention is projected to be a 4-session intervention delivered by a trained therapist to individual couples facing mCRC (i.e., a patient and his/her intimate partner) via video-conference (e.g., Zoom).
Interventions
BEHAVIORALQualitative 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.
BEHAVIORALCognitive 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.
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify the needs of mCRC patients for intervention content | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the preferences of mCRC patients for intervention content | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the needs of mCRC patients' partners for intervention content | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the preferences of mCRC patients' partners for intervention content | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the preferences of mCRC patients for intervention format (eg, session length) | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the preferences of mCRC patients' partners for intervention format (eg, session length) | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Identify the preferences of mCRC patients partners for intervention format | During the one-time qualitative interview | Completed through semi-structured qualitative interviews |
| Extract key themes to integrate into preliminary drafts | During the one-time qualitative interview | analyze these qualitative data to extract key themes and will integrate the findings with preliminary drafts of the MIND-Together protocol (e.g., participant handouts, therapist manual). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren Zimmaro
University of Colorado, Denver
Outcome results
None listed