- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943174
MIND Programme for Cancer Patients
MIND Programme for Cancer Patients: A Group Intervention Programme Based on Third Wave Psychotherapies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of breast cancer (stages I-III)
Exclusion Criteria:
- severe psychopathology
- difficulty in completing self-report measures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIND Programme for cancer
MIND programme for cancer is a manualized acceptance, mindfulness and compassionate-based group intervention for cancer patients. It included 8 weekly group sessions, 2h hours each, run in small groups (ranging from 6 to 12 participants). Participants in this group also receive cancer treatment as usually performed at the Coimbra University Hospital. |
Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual
Standard personalized treatment of cancer
|
|
Other: Treatment as Usual (TAU)
Cancer treatment as usually performed at the Coimbra University Hospital.
|
Standard personalized treatment of cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in psychopathology (namely, depression and anxiety symptoms)
Time Frame: From Baseline to follow-up
|
Measured by DASS-21
|
From Baseline to follow-up
|
|
Changes in Quality of Life
Time Frame: From Baseline to follow-up
|
Measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
|
From Baseline to follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CINEICC-1-IAT
- SFRH/BD/101906/2014 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia)
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