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Completed

NCT Number: NCT02943174

MIND Programme for Cancer Patients

This investigation aims to apply and test the acceptability of an acceptance, mindfulness and compassionate-based intervention structured for cancer patients. MIND programme for cancer thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups at an Oncology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase participants' physical and psychosocial quality of life, and attenuate depressed mood and anxiety.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The sample will include diagnosed cancer patients recruited at an Oncology Service at the Coimbra's University Hospital. Patients will be approached by their doctor to assess their level of interest in the investigation. Patients who demonstrate interest will go through a Screening interview conducted by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the patient meets the inclusion criteria for the study. Patients who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent. All ethical requirements for research with humans are guaranteed.

Afterwards, participants will be allocated in two groups (experimental and control group). Both groups will maintain the medical treatment as usual (TAU). Additionally, the experimental group will enroll in the MIND programme for cancer patients, also provided by a licensed psychologist.

Both groups will concurrently complete a protocol of self-report measures and their medical data will be collected by the medical staff of the Hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of breast cancer (stages I-III)

Exclusion criteria

  • severe psychopathology
  • difficulty in completing self-report measures

Treatment and study plan

MIND programme for cancer patients

Behavioral

Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual

Treatment as usual (TAU)

Other

Standard personalized treatment of cancer

Primary outcomes

  1. Changes in psychopathology (namely, depression and anxiety symptoms)

    Time frame: From Baseline to follow-up

    Measured by DASS-21

  2. Changes in Quality of Life

    Time frame: From Baseline to follow-up

    Measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

MIND Programme for Cancer Patients: A Group Intervention Programme Based on Third Wave Psychotherapies

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 24, 2016
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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