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Can a smart digital program restore sleep for cancer survivors?

NCT ID NCT06813235

Symptom relief Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This pilot trial tests an adaptive stepped-care digital intervention to improve sleep in Chinese cancer survivors with mild-to-moderate insomnia. Participants first receive a self-guided web-based CBT-I program or a simple exercise program; those who don't improve may be stepped up to a more intensive multi-component therapy. The study aims to see if this approach is feasible, acceptable, and potentially helpful for improving 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
A stepped-care digital intervention combining web-based cognitive behavioral therapy for insomnia (CBT-I) and an exercise program, with escalation to a more intensive multi-component therapy if needed.
What this could lead to
If successful, this could provide a scalable, personalized digital approach to improve sleep quality in cancer survivors, potentially reducing distress and enhancing recovery.
What could go wrong
This is a small pilot study focused on feasibility, not effectiveness. The intervention may not be acceptable to all participants, and results may not generalize beyond Chinese cancer survivors with mild-to-moderate insomnia.

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 72 people

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

Started

Feb 2025

Expected to finish

Feb 2027

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.

Inclusion Criteria: * Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer * Completed treatment (except endocrine therapy) within two years * Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance Exclusion Criteria: * Diagnosis of metastatic cancer * Current diagnosis of psychiatric disorder * Current diagnosis of another sleep disorder, * Have received psychological treatment specifically for sleep disturbance

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Conditions

The condition(s) this trial relates to.

breast cancer colorectal cancer female reproductive organ cancer insomnia neoplasm Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasm Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • QMH department of surgery

    RECRUITING

    Hong Kong, Hong Kong

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