Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K08CA267313 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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 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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative interview | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the needs of mCRC patients for intervention content | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the preferences of mCRC patients for intervention content | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the needs of mCRC patients' partners for intervention content | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the preferences of mCRC patients' partners for intervention content | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the preferences of mCRC patients for intervention format (eg, session length) | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the preferences of mCRC patients' partners for intervention format (eg, session length) | Completed through semi-structured qualitative interviews | During the one-time qualitative interview |
| Identify the preferences of mCRC patients partners for intervention format | Completed through semi-structured qualitative interviews |
Not provided
Not provided
Patient Inclusion Criteria:
Additional patient participant inclusion criteria:
Additional partner participant inclusion criteria:
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
Not provided
Not provided
Metastatic Colorectal Cancer Patients
Metastatic Colorectal Cancer Patients' Partners
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaylee Ortega | Contact | 720-288-0714 | kaylee.ortega@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Zimmaro | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Recruiting | Aurora | Colorado | 80045 | United States |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cognitive Interviews | Behavioral | 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. |
|
| During the one-time qualitative interview |
| Extract key themes to integrate into preliminary drafts | 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). | During the one-time qualitative interview |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |