RecruitingNot applicable

Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Mindful PaCT, a new mindfulness program for couples. It is for people with colorectal cancer that has spread to other parts of the body and their romantic partners. The study asks whether the program is practical to finish, helpful, well-liked, and meets their needs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and no older than 85.
  • Be able to sign and date the consent form, follow study steps, and take part for the whole study.
  • Be able to read study materials on your own in English, and speak and understand English.
  • Be a patient with current colorectal cancer that has spread (stage IV or recurrent), or that patient's romantic partner.
  • Have been in a committed romantic relationship for more than 6 months. Patients with more than one partner must choose one main partner for the study.
  • Have a score above 0 on the Distress Thermometer, a tool that measures distress.
  • Have internet access and a phone, tablet, or computer that supports video calls.
  • For patients: have an ECOG activity score below 2, meaning you can do most daily activities, or have a clinician decide you can take part.

Who can't join

  • Either partner has a serious mental illness that is active or poorly controlled, memory or thinking problems such as dementia, or another health problem that would prevent taking part.
  • Either partner is too physically or mentally ill to join sessions and complete surveys.
  • The couple is currently in couples or marriage therapy together.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 * 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. Exclusion Criteria: * 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.

Study sites (1)

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