Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives

Study Overview
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Brief Summary
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The importance of emotional regulation interventions in cancer patients and primary caregivers is clearly established, since it helps them manage their emotions. The aim of the study was to analyze the differential effect between two Emotional Support programs, one of them based on Mindfulness, and the other one Emotional Support as usual, on advanced cancer patients (stage III & IV) admitted to a Madrid Community Hospital La Paz and their relatives.

Detailed Description
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It is clearly demonstrated that Emotional Regulation interventions are very important in cancer patients in any stage of the disease. Great emotional burden has also been described in case of main caregivers and other relatives of the patients. Diagnosis, treatment and survival of cancer patients are related to a complex set of stressors that have their own effects on the results of the treatments: activity daily life changes, social impairment, role changes, thought about the possibility of a relapse and possibility of death… It has been elucidated that psychological interventions, as cognitive therapy or other types of psychotherapy, may improve the psychosocial outcomes (for example, quality of life). During the last years, many researches have assessed the effect of Mindfulness interventions on cancer patients. Mindfulness is defined as the intention of paying full attention, moment to moment, to your experiences, without judgement. Regular Mindfulness practice cultivates an acceptance state, improves emotional regulation strategies, improves quality of life, reduces rumination thinking, anxiety and depression. The general aim of the present investigation is studying the effect of an Emotional Supportive based-mindfulness Program versus an Emotional Supportive Program (without Mindfulness component). Both programs are offered to cancer patients in an advanced stage of disease, admitted in the oncology section of the Hospital Universitario La Paz, and their relatives. The investigator's hypothesis are: Both programs will reduce emotional distress, decreasing from 4 to 5 points out of 10 on average on the Distress thermometer (DT). Both interventions will improve moderately the score on Quality of Life measures (EORTC QLQ-15-PAL), obtaining 10-20 more points than at the initial assessment. Both interventions will reduce the emotional burden of the main caregiver (ZARIT short-form), obtaining a score under 17 points, which indicates no familiar giving-up. Emotional Supportive based-Mindfulness Program will improve the scores on Philadelphia Mindfulness Scale (PHLMS) and acceptance, more than the Emotional Supportive Program will do. The investigators will conduct a Randomized Controlled Trial with two treatment arms in an advanced-cancer patients sample of patients under hospitalization at Hospital Universitario La Paz, Madrid. After all recollection of data is done, the investigators will conduct statistic analysis in order to accept or refuse our hypothesis.

Official Title
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Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Emotional Supportive Mindfulness-based Program
* Behavioral: Emotional Supportive Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old. Being in treatment in one of the Oncology units at Hospital Universitario La Paz. Capable of a minimum level of performance that allows intervention. The doctor responsible of the patient considers that the program will help the cancer patient and that the patient is capable to participate on it. Capable of understanding and giving his or her written informed consent. Exclusion Criteria: Intellectual disability or cognitive impairment or dementia. Insufficient knowledge of the language to understand and participate on the intervention program. Serious mental illness in acute state at the moment of the beginning of the intervention. Autolytic ideas at the moment of the assessment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotional Supportive Mindfulness-based Program<br>The program is based on 15/20 minutes sessions of meditative practices in which can participate only the patients, only his/her caregiver, or both. Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. | Behavioral: Emotional Supportive Mindfulness-based Program<br>* Mindfulness training<br>|
| Active Comparator: Emotional Supportive Program<br>The program is based on 15/20 minutes sessions based on narrative therapy, in which the patient or his/her caregiver or both can talk about their emotions. Number of sessions is an independent outcome, because it depends on the number of days of hospitalization. | Behavioral: Emotional Supportive Program<br>* Narrative-orientated therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindfulness | Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance. | At day one of the intervention | 
| Mindfulness | Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance. | At the end of the six sessions(each session is every three days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. | Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL). | At day one of the intervention | 
| Caregiver emotional burden. | Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations. | At day one of the intervention | 
| Emotional distress | Distress thermometer (DT), scores from 1 to 10. Emotional distress. | At day one of the intervention | 
| Daily life Performance | Karnofsky Performance Status. It gives a measure of the dependency level of the patients, and the level of support that the cancer patient needs. | At day one of the intervention | 
| Number of sessions | number of sessions of emotional support intervention or mindfulness emotional support intervention | At the end of the six sessions(each session is every three days) | 
| Quality of life. | Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL). | At the end of the six sessions(each session is every three days) | 
| Caregiver emotional burden. | Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations. | At the end of the six sessions(each session is every three days) | 
| Emotional distress | Distress thermometer (DT), scores from 1 to 10. Emotional distress. | At the end of the six sessions(each session is every three days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Oncology, Cancer, Emotional distress, Quality of life