An interventional study of Couple-based Mindfulness Intervention and Health and Wellness Education Control Condition in Colorectal Cancer and Metastatic Colorectal Cancer (CRC), sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
Among 15 studies in Colorectal Neoplasms by University of Colorado, Denver — 3 open to participants now, 5 under way, none of them phase 3. Colorectal Neoplasms · University of Colorado, Denver.
Among the 15 studies in Colorectal Neoplasms by University of Colorado, Denver, this one is the 2nd largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 with no phase, and was the 15th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →3 of the 15 studies in Colorectal Neoplasms by University of Colorado, Denver are open now, in 1 country. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Ages 18–99 · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 45–75 · Healthy volunteers
By country, each count listing its studies:
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 19 across the 11 interventional studies, 200 across the 4 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Colorectal Neoplasms by University of Colorado, Denver, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional eligibility criteria include:
Additional patient participant inclusion criteria:
Additional partner participant inclusion criteria:
Eligibility for relationship status will be self-reported by participants during recruitment.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Couple-based Mindfulness Intervention
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.
Behavioral: Health and Wellness Education Control Condition
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.
Also known as: Mindful 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.
Also known as: Wellness PaCT
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).
Time frame: 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).
Time frame: 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.
Time frame: From enrollment through post-intervention assessment at approximately 8 weeks
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. a. Client Satisfaction Questionnaire-8 item (CSQ-8) mean score \> 28
Time frame: At post-intervention assessment at approximately 8 weeks
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 48 months is above that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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University of Colorado, Denver →