Colorectal CancerNCT07759921
Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
A study testing Couple-based Mindfulness Intervention in people with Colorectal Cancer and Metastatic Colorectal Cancer (CRC), run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for 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
- Colorectal Cancer, Metastatic Colorectal Cancer (CRC)
- What is being tested?
- Couple-based Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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 to 85.
- Fluent in English language. All study materials, including the informed consent form, participant workbooks, and questionnaires, are currently available only in English. Participation requires the ability to independently read and engage with written study materials (including the participant workbook), which are integral to the intervention session content and home practices. Therefore, individuals who are unable to read study materials in English are not eligible to participate. At this time, the intervention has not been translated or validated in other languages, therefore participation is limited to individuals who can read, speak, and understand English to ensure that participants are able to fully engage with study activities.
- Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC) or a partner (e.g., spouse) of someone diagnosed with mCRC.
- Indicates a score >0 on the Distress Thermometer
Show all 15Show fewer
- Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
- Additional eligibility criteria include:
- 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. Monogamy is not required for eligibility; however, in cases of polyamorous relationships, the patient will designate a primary partner for participation in the study.
- Additional partner participant inclusion criteria:
- Has been in a committed relationship >6 months with a patient who meets the above eligibility criteria
- Eligibility for relationship status will be self-reported by participants during recruitment.
Who cannot join
- One or both members of the couple has an active or poorly controlled 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.
- The couple is currently in active couples (e.g., marital) therapy together.
- Participants who are physically or mentally too ill to participate or those with major cognitive impairments are excluded because they may not be able to engage with intervention sessions, surveys. No exclusions will be made based on sexual orientation, race, gender, or other sociodemographic features. Because patients with mCRC are living longer, and patients and partners can experience distress at various times since their diagnosis, we do not limit participation by time since diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Kaylee Ortega, 303-724-8895, kaylee.ortega@cuanschutz.edu
Lauren Zimmaro, PhD
About this study
Official title: Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial
The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.
Read the detailed description
Metastatic colorectal cancer (mCRC) causes significant distress in patients and partners. Mindfulness-based interventions (MBIs) can reduce distress but existing MBIs have limitations for mCRC couples. An MBI tailored to mCRC couples' needs and delivered via video-conferencing could remedy such limitations and reduce distress in this population. This new intervention, called Mindful PaCT, has been preliminarily developed and now needs to be assessed for feasibility, acceptability, and preliminary psychosocial effects.
- Being tested
- Couple-based Mindfulness Intervention, Health and Wellness Education Control Condition
- Keywords
- Couple, Partner, Caregiver
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based Mindfulness InterventionBehavioural
Also called Mindful PaCT
Mindful PaCT is a manualized, couple-based mindfulness intervention designed to reduce distress and strengthen coping among patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Sessions address four core mindfulness competencies: awareness, acceptance, compassion, and connection. Intervention content includes mindfulness-based education, guided experiential exercises, and skill-building activities designed to support individual and relational coping and adjustment in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental audio and video recordings of guided mindfulness practices to support between-session practice and continued skill development.
Health and Wellness Education Control ConditionBehavioural
Also called Wellness PaCT
Wellness PaCT is a manualized, couple-based educational intervention designed as an active, attention-matched control condition for patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Each session focuses on a wellness topic relevant to coping with metastatic colorectal cancer: general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Intervention content includes health education and structured activities intended to support healthy lifestyle behaviors in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental educational resources to support continued learning between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mindful PaCT | Experimental | Patient-partner dyads assigned to this arm receive Mindful PaCT, a couple-based mindfulness program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist. Couples also receive a program workbook and access to supplemental audio and video mindfulness practices for use between sessions. Receives: Behavioral: Couple-based Mindfulness Intervention |
| Wellness PACT | Placebo comparator | Patient-partner dyads assigned to this arm receive Wellness PaCT, a couple-based educational program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist and address general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Couples also receive a program workbook and supplemental educational resources for use between sessions. Receives: Behavioral: Health and Wellness Education Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention through Study Accrual
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer.
Accrual feasibility will be indicated by: Recruitment and accrual efficiency, defined as enrolling >50% of eligible approached couples (i.e., 45 couples after approaching fewer than 90 couples).
Measured: From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility of Intervention through Intervention Retention Rates
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer.
Retention feasibility will be indicated by: Intervention retention rate of > 70% Mindful PaCT couples (i.e., complete assessments at both pre-and post-intervention timepoints).
Measured: From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility of Intervention through Intervention Completion Rates
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer.
Session completion feasibility will be indicated by: Intervention completion rate, defined by attendance of all 4 Mindful PaCT sessions, in > 50% of couples.
Measured: From enrollment through post-intervention assessment at approximately 8 weeks
Secondary outcomes (1)
Participant Satisfaction Score of the PaCT Program
To evaluate acceptability of the Mindful PaCT program, all participants will be asked to complete an 8-item client satisfaction questionnaire to gauge how satisfied they are with the quality of the program and identify areas for improvement.
- Client Satisfaction Questionnaire-8 item (CSQ-8) mean score > 28
Measured: At post-intervention assessment at approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
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, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759921
- Sponsor's protocol ID
- 26-0360.cc
- Other IDs
- K08CA267313
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 14 Aug 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759921
- Acronym / sponsor ID
- 26-0360.cc
- Keywords
- Couple, Partner, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Aug 2026 (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 learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.
Detailed description
Metastatic colorectal cancer (mCRC) causes significant distress in patients and partners. Mindfulness-based interventions (MBIs) can reduce distress but existing MBIs have limitations for mCRC couples. An MBI tailored to mCRC couples' needs and delivered via video-conferencing could remedy such limitations and reduce distress in this population. This new intervention, called Mindful PaCT, has been preliminarily developed and now needs to be assessed for feasibility, acceptability, and preliminary psychosocial effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful PaCT | Experimental | Behavioral: Couple-based Mindfulness InterventionPatient-partner dyads assigned to this arm receive Mindful PaCT, a couple-based mindfulness program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist. Couples also receive a program workbook and access to supplemental audio and video mindfulness practices for use between sessions. |
| Wellness PACT | Placebo comparator | Behavioral: Health and Wellness Education Control ConditionPatient-partner dyads assigned to this arm receive Wellness PaCT, a couple-based educational program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist and address general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Couples also receive a program workbook and supplemental educational resources for use between sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 to 85.
- Fluent in English language. All study materials, including the informed consent form, participant workbooks, and questionnaires, are currently available only in English. Participation requires the ability to independently read and engage with written study materials (including the participant workbook), which are integral to the intervention session content and home practices. Therefore, individuals who are unable to read study materials in English are not eligible to participate. At this time, the intervention has not been translated or validated in other languages, therefore participation is limited to individuals who can read, speak, and understand English to ensure that participants are able to fully engage with study activities.
- Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC) or a partner (e.g., spouse) of someone diagnosed with mCRC.
Key exclusion criteria (3 listed)
- One or both members of the couple has an active or poorly controlled 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.
- The couple is currently in active couples (e.g., marital) therapy together.
- Participants who are physically or mentally too ill to participate or those with major cognitive impairments are excluded because they may not be able to engage with intervention sessions, surveys. No exclusions will be made based on sexual orientation, race, gender, or other sociodemographic features. Because patients with mCRC are living longer, and patients and partners can experience distress at various times since their diagnosis, we do not limit participation by time since diagnosis.
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 |
|---|---|---|
| Couple-based Mindfulness InterventionAlso: Mindful PaCTMindful PaCT is a manualized, couple-based mindfulness intervention designed to reduce distress and strengthen coping among patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Sessions address four core mindfulness competencies: awareness, acceptance, compassion, and connection. Intervention content includes mindfulness-based education, guided experiential exercises, and skill-building activities designed to support individual and relational coping and adjustment in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental audio and video recordings of guided mindfulness practices to support between-session practice and continued skill development. | Behavioural | Mindful PaCT |
| Health and Wellness Education Control ConditionAlso: Wellness PaCTWellness PaCT is a manualized, couple-based educational intervention designed as an active, attention-matched control condition for patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Each session focuses on a wellness topic relevant to coping with metastatic colorectal cancer: general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Intervention content includes health education and structured activities intended to support healthy lifestyle behaviors in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental educational resources to support continued learning between sessions. | Behavioural | Wellness PACT |
Primary outcome
Feasibility of Intervention through Study Accrual
Time frame: From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Accrual feasibility will be indicated by: Recruitment and accrual efficiency, defined as enrolling >50% of eligible approached couples (i.e., 45 couples after approaching fewer than 90 couples).
Feasibility of Intervention through Intervention Retention Rates
Time frame: From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Retention feasibility will be indicated by: Intervention retention rate of > 70% Mindful PaCT couples (i.e., complete assessments at both pre-and post-intervention timepoints).
Feasibility of Intervention through Intervention Completion Rates
Time frame: From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Session completion feasibility will be indicated by: Intervention completion rate, defined by attendance of all 4 Mindful PaCT sessions, in > 50% of couples.
1 secondary outcome
Participant Satisfaction Score of the PaCT Program
Time frame: At post-intervention assessment at approximately 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
Lauren Zimmaro, PhD 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?
A study testing Couple-based Mindfulness Intervention in people with Colorectal Cancer and Metastatic Colorectal Cancer (CRC), 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 15 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Aug 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaylee Ortega (3037248895, kaylee.ortega@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention through Study Accrual (time frame: From enrollment through post-intervention assessment at approximately 8 weeks). The study lists 3 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 Aug 2026.