A Study Of Brief Mind-body Intervention For Cancer Related Insomni
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 25-012246
Sponsor Protocol Number: 25-012246
About this study
The purpose of this study is to determine changes in sleep characteristics [insomnia severity (Insomnia Severity Index), total sleep time, sleep onset latency, and sleep efficiency], fatigue, and quality of life at enrollment (T1) one week (T2) and four weeks (T3) and twelve weeks (T4) following completion of the second session of ART. Investigate variation in treatment response by level of insomnia (Insomnia Severity Index) and fatigue, cancer stage, current cancer treatment, and baseline level of emotional distress (PHQ-9, GAD-7) and trauma (PCL-5).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
To be eligible for the study, individuals must be 18 years of age or older; able to read, write and understand English; have a cancer diagnosis; report insomnia with a score of 8 or more on the Insomnia Severity Index (ISI); denial of suicidal ideation or intent, with no evidence of psychotic behavior; willing and able to utilize secure web conferencing software (participants 15-30) or to travel to Mayo Clinic (participants 1-15).
Exclusion Criteria:
Individuals with severe depression (PHQ-9 >20), bipolar disorder, seizure disorders, untreated sleep apnea, untreated restless legs syndrome, narcolepsy, nightshift or rotating shift workers, and those who plan to travel across two or more time zones time zones within the first 6 weeks of enrollment will be excluded.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/23/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Cindy Tofthagen, Ph.D., R.N. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available