Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02423720
Eligibility Criteria:
Inclusion Criteria:
Eligible patients must:
* Carry a diagnosis of metastatic colon, rectum, or small bowel adenocarcinoma
* Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
* Have life expectancy of at least 6 months
* Have Karnofsky Performance Status ≥60
* Be able to speak and read English
* Have access to a mobile phone
* Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
* Have a distress level of ≥3 on the NCCN Distress Thermometer (DT).\[1, 40\]
* An effort will always be made to recruit patient and caregiver pairs, but unpaired patients are also eligible
Eligible caregivers are a spouse/partner, other family member, or a close friend of a patient with metastatic colon, rectum, or small bowel adenocarcinoma.
Eligible caregivers must:
* Be able to speak and read English
* Have access to a mobile phone
* Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
Exclusion Criteria:
This study is limited the study to patients with metastatic colon, rectum, or small bowel adenocarcinoma, because treatment regimens and disease trajectories for these disease groups are similar.
Deafness, Current meditation practice (\>2 episodes or \>1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because the study is designed as an audio-based introduction to mindfulness meditation.
Patients with a DT level \>7 will be considered on a case-by- case basis. Patients and caregivers who participate in a focus group and meet criteria for the intervention will be given the opportunity to participate: data will be collected, but these patients/participants will not be included in the final analyses so as not to bias the results.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02423720
Study Brief:
Protocol Section:
NCT02423720