Mind Programme for Women With Breast Cancer (Nationwide Coverage) (MIND(n))

University of Coimbra

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Behavioral: Support Group; Behavioral: Mind Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT06212414

CINEICC-3-IAT(n)

Details and patient eligibility

About

The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial

Enrollment: 153 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age between 18-70;
2. primary diagnosis of BC (stages between I and III);
3. having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in Portugal;
4. able to understand and answer to self-report questionnaires in Portuguese;
5. having access to a computer or tablet with internet.

Exclusion criteria

1. currently undergoing any form of psychological intervention;
2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
3. diagnosis of neurological disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 3 patient groups

Mind programme

Experimental group

Description:

This group will receive the Mind programme. This intervention comprises 8 weekly group sessions, with the duration of 120 minutes each, to be delivered via Zoom. Integration of Acceptance and Commitment Therapy, mindfulness and Compassion Focused Therapy components, adapted to women with breast cancer. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.

Treatment:

Behavioral: Mind Programme

Support group

Active Comparator group

Description:

This group will receive a 8-week support group intervention (weekly sessions, with the duration of 120 minutes each), via Zoom. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.

Treatment:

Behavioral: Support Group

Waiting list (Treatment As Usual / No psychological intervention)

No Intervention group

Description:

This group will receive the (psychological) treatment as usual in Portugal (no treatment), besides the recommended medical treatment for their clinical diagnosis. At the end of this research project, the intervention that proves to be most efficacious will be offered to participants from the waiting list condition.