Metastatic Colorectal CancerNCT05840263
Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Qualitative interview and Cognitive Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- ∙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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
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.
Read the 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).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Qualitative interview, Cognitive Interviews
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewBehavioural
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 InterviewsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Qualitative interview; Behavioral: 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. Receives: Behavioral: Qualitative interview; Behavioral: 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. Receives: Behavioral: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the needs of mCRC patients for intervention content
Completed through semi-structured qualitative interviews
Measured: During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention content
Completed through semi-structured qualitative interviews
Measured: During the one-time qualitative interview
Identify the needs of mCRC patients' partners for intervention content
Completed through semi-structured qualitative interviews
Measured: During the one-time qualitative interview
Identify the preferences of mCRC patients' partners for intervention content
Completed through semi-structured qualitative interviews
Measured: During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention format (eg, session length)
Completed through semi-structured qualitative interviews
Measured: 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
Measured: During the one-time qualitative interview
Identify the preferences of mCRC patients partners for intervention format
Completed through semi-structured qualitative interviews
Measured: 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).
Measured: During the one-time qualitative interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start31 May 2023
- Primary completion20 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lauren Zimmaro, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840263
- Sponsor's protocol ID
- 22-2246.cc
- Other IDs
- K08CA267313
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
- ClinicalTrials.gov ID
- NCT05840263
- Acronym / sponsor ID
- 22-2246.cc
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic Colorectal Cancer Patients | – | Behavioral: Qualitative interview, Behavioral: Cognitive InterviewsWe 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 | – | Behavioral: Qualitative interview, Behavioral: Cognitive InterviewsWe 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 | – | Behavioral: Qualitative interviewWe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- ∙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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewQualitative 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. | Behavioural | Clinicians, Metastatic Colorectal Cancer Patients, Metastatic Colorectal Cancer Patients Partners |
| Cognitive InterviewsThe 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. | Behavioural | Metastatic Colorectal Cancer Patients, Metastatic Colorectal Cancer Patients Partners |
Primary outcome
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 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
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 (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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Zimmaro principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the needs of mCRC patients for intervention content (time frame: During the one-time qualitative interview). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.