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Mindfulness may ease distress in breast cancer radiotherapy

NCT ID NCT06025799

Symptom relief Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 17, 2026 · Updated 5 times

Summary

This trial tests whether a four-week mindfulness program, delivered by a nurse, can reduce psychological distress and increase hope and mindfulness in women with breast cancer receiving radiotherapy. One hundred women who had mastectomy and are now undergoing radiotherapy are randomly assigned to either standard care or standard care plus the mindfulness program. The program includes eight face-to-face sessions with breathing exercises, body scans, meditation, and gentle movement, plus home practice. Researchers measure changes in distress, hope, and mindfulness before, right after, and one month after the program ends.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adapted mindfulness-based stress reduction program
What this could lead to
If effective, this program could offer a low-cost, non-drug way to ease emotional distress and improve well-being for women during breast cancer radiotherapy.
What could go wrong
This is a small, early-stage study with 100 participants, so results may not apply to all patients. The program requires time and commitment, and benefits may vary.

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

100 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2023

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

Female participants only

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: Adult women with non-metastatic breast cancer who were receiving post-mastectomy radiotherapy were eligible. Participants had to be within one to six months after mastectomy, able to read and write, able to communicate verbally, available for follow-up, and willing to provide informed consent and undergo randomization. Ability to read and write was required because participants completed self-administered outcome questionnaires and used written intervention materials, home-practice instructions, and weekly practice diaries. Exclusion Criteria: Participants were excluded if they had metastatic disease, current alcohol or drug misuse, serious comorbid conditions such as renal, cardiac, or liver disease, or any condition that limited their ability to complete the study procedures or outcome assessments.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Alexandria Ayadi Al Mostakbal Oncology Center

    Alexandria, Egypt, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.