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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02943174
Other study ID # CINEICC-1-IAT
Secondary ID SFRH/BD/101906/2
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date April 2018

Study information

Verified date May 2019
Source University of Coimbra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- diagnosis of breast cancer (stages I-III)

Exclusion Criteria:

- severe psychopathology

- difficulty in completing self-report measures

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MIND programme for cancer patients
Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual
Other:
Treatment as Usual (TAU)
Standard personalized treatment of cancer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Coimbra

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in psychopathology (namely, depression and anxiety symptoms) Measured by DASS-21 From Baseline to follow-up
Primary Changes in Quality of Life Measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) From Baseline to follow-up
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