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临床试验/NCT02943174
NCT02943174已完成不适用

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

University of Coimbra0 个研究点目标入组 32 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Changes in Quality of Life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of breast cancer (stages I-III)

排除标准

  • severe psychopathology
  • difficulty in completing self-report measures

研究组 & 干预措施

MIND Programme for cancer

Experimental

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.

干预措施: MIND programme for cancer patients (Behavioral)

Treatment as Usual (TAU)

Other

Cancer treatment as usually performed at the Coimbra University Hospital.

干预措施: Treatment as Usual (TAU) (Other)

MIND Programme for cancer

Experimental

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.

干预措施: Treatment as Usual (TAU) (Other)

结局指标

主要结局

Changes in Quality of Life

时间窗: From Baseline to follow-up

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

Changes in psychopathology (namely, depression and anxiety symptoms)

时间窗: From Baseline to follow-up

Measured by DASS-21

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inês A Trindade

PhD

University of Coimbra

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