A good Night's sleep after cancer: can tailored Mind-Body training deliver?
NCT ID NCT07800715
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers are testing two behavioral programs to help Hispanic cancer survivors with insomnia. One combines gentle movement, meditation, and breathing. The other uses cognitive behavioral therapy for insomnia. Both are being culturally adapted with input from survivors. The study will check if the programs are practical and acceptable, and whether they improve sleep quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Behavioral interventions: Body-Mind Training and Cognitive Behavioral Therapy for Insomnia, culturally adapted for Hispanic cancer survivors
- What this could lead to
- If these programs work, they could offer Hispanic cancer survivors a practical, culturally fitting way to improve sleep without medication.
- What could go wrong
- This is a small early-stage study focused on feasibility, not proof of effectiveness. The programs may not improve insomnia more than usual care, and results may not apply to all survivors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Aim 1 (Cultural Adaptation): Inclusion Criteria: * Be 18 years of age or older * Be at least 18 years old when received their cancer diagnosis * Self-identify as Hispanic and/or Latino(a) * Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy * Completion of primary cancer treatment in the past 3 months - 5 years (may be on hormonal therapy and/or immunotherapy or other long-term therapies) * Have sleep disturbance (indicated by a response of 3 or more on the MDASI sleep question by using an 11-point scale anchored by 0 \[no sleep disturbance\] and 10 \[worst possible sleep disturbance\] * Be able to read and understand English and/or Spanish Exclusion Criteria: * Inability to speak and read English or Spanish proficiently * Life expectancy \<12 months Aims 2-3 (RCT): Inclusion Criteria: * Be 18 years of age or older * Self-identify as Hispanic and/or Latino(a) * Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy * Completion of primary cancer treatment in the past 3 months - 5years (may be on hormonal therapy and/or immunotherapy or other long-term therapies) Report sleep difficulties ≥3 times per week for ≥3 months consistentwith DSM-5 insomnia criteria4, * Must have a score of ≥10 on the Insomnia Severity Index * Must have a personal mobile device (i.e., mobile smart phone, laptop, desktop computer, tablet) with active internet * Be able to read and understand English and/or Spanish * Physically Inactive (\<150 minutes of vigorous exercise/week within the past 3 months) Exclusion Criteria: * Current or last year practice of TCQ or similar practices; * Current or past CBT-I treatment, * Shift worker, * Life expectancy \<12 months, * Health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems. * Participants with a history of diagnosed sleep apnea or restless leg syndrome (RLS) will be excluded from the study, as both increase the risk for insomnia. All other participants will complete the STOP-Bang Sleep Apnea Screening Tool and a single RLS screening question during screening, as both are underdiagnosed in Hispanics. Those scoring ≥ 5 on the STOP-Bang, indicating high risk for moderate-to-severe sleep apnea, or who respond with 'Yes' on the RLS risk tool, will also be excluded and referred to a sleep medicine specialist for evaluation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
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A doctor treating you
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