A Study Of Brief Mind-body Intervention For Cancer Related Insomni

Overview

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

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

Clinical Trials