MIND Programme for Cancer Patients

NCT ID: NCT02943174

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-04-30

Brief 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.

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MIND programme for cancer patients

Intervention Type: BEHAVIORAL

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

Treatment as Usual (TAU)

Intervention Type: OTHER

Standard personalized treatment of cancer

Treatment as Usual (TAU)

Cancer treatment as usually performed at the Coimbra University Hospital.

Group Type: OTHER

Treatment as Usual (TAU)

Intervention Type: OTHER

Standard personalized treatment of cancer

Interventions

MIND programme for cancer patients

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

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Standard personalized treatment of cancer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of breast cancer (stages I-III)

Exclusion Criteria

• severe psychopathology
• difficulty in completing self-report measures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Inês A Trindade

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SFRH/BD/101906/2014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CINEICC-1-IAT

Identifier Type: -

Identifier Source: org_study_id