A good Night's sleep after cancer: can tailored Mind-Body training deliver?

NCT ID NCT07800715

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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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As listed by the trial registrant

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