Colorectal Cancer, Metastatic Colorectal Cancer (CRC)
Conditions
Keywords
Couple, Partner, Caregiver
Brief 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.
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.
Interventions
BEHAVIORALCouple-based Mindfulness Intervention
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.
BEHAVIORALHealth and Wellness Education Control Condition
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.
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention through Study Accrual | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction Score of the PaCT Program | At post-intervention assessment at approximately 8 weeks | 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 |
Countries
United States
Contacts
CONTACTKaylee Ortega
PRINCIPAL_INVESTIGATORLauren Zimmaro, PhD
University of Colorado, Denver
Outcome results
None listed