Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
Overview
- Phase
- Not Applicable
- Intervention
- Qualitative interview
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- University of Colorado, Denver
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Identify the preferences of mCRC patients' partners for intervention content
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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).
Investigators
Eligibility Criteria
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
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
Arms & Interventions
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.
Intervention: Qualitative interview
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.
Intervention: Cognitive Interviews
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.
Intervention: Qualitative interview
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.
Intervention: Cognitive Interviews
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.
Intervention: Qualitative interview
Outcomes
Primary Outcomes
Identify the preferences of mCRC patients' partners for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention format (eg, session length)
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients partners for intervention format
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the needs of mCRC patients' partners for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Extract key themes to integrate into preliminary drafts
Time Frame: 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).
Identify the needs of mCRC patients for intervention content
Time Frame: 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)
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews