CompletedNot Applicable

Nurse-Delivered Adapted MBSR During Breast Cancer Radiotherapy

Egypt100 participantsStarted 2023-09-03

Plain-language summary

This randomized study examined whether adding a condensed mindfulness programme to standard radiotherapy care could improve psychosocial outcomes among women treated for breast cancer. One hundred participants were assigned to routine care alone or routine care together with the nurse-facilitated programme. Emotional distress, hope, and mindfulness were evaluated before the programme, directly after its completion, and approximately one month later.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is completed, would it be possible to see the results showing whether the nurse-delivered mindfulness program actually reduced anxiety, depression, or stress for women going through breast cancer radiotherapy?
2This program was adapted specifically to fit into radiotherapy appointments — how realistic would it be for me to take part in something like this given my own treatment schedule, and is a mindfulness-based approach something my care team could support me with now?
3The trial measured 'hope' using a specific scale alongside distress — does my care team think psychological support like mindfulness training is something I should be pursuing alongside my radiotherapy, or is there a different approach they'd recommend first?
4Since this was delivered by nurses rather than specialist therapists, does that mean a program like this could realistically be offered at the cancer center where I'm being treated, or would I need to seek out a separate referral?
5Are there standard-of-care psychological support options already available to me during radiotherapy that are similar to what was tested in this trial, so I don't have to wait for a research program to access this kind of help?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) total score

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in hope assessed by the Herth Hope Index (HHI)

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Trial details

NCT IDNCT06025799

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-06

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) total score

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in hope assessed by the Herth Hope Index (HHI)

Timeframe: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.