MIND Programme for Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: MIND programme for cancer patients
* Other: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of breast cancer (stages I-III) Exclusion Criteria: severe psychopathology difficulty in completing self-report measures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIND Programme for cancer<br>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. | Behavioral: MIND programme for cancer patients<br>* Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual<br>Other: Treatment as Usual (TAU)<br>* Standard personalized treatment of cancer<br>|
| Other: Treatment as Usual (TAU)<br>Cancer treatment as usually performed at the Coimbra University Hospital. | Other: Treatment as Usual (TAU)<br>* Standard personalized treatment of cancer<br>|

What is the study measuring?
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Primary Outcome Measures

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