Clinical trial NCT03492073: Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
Official title: Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Mindfulness
Oncology
Cancer
Emotional distress
Quality of life
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mindfulness
timeFrame: At day one of the intervention
measure: Mindfulness
timeFrame: At the end of the six sessions(each session is every three days)
Secondary outcomes:
measure: Quality of life.
timeFrame: At day one of the intervention
measure: Caregiver emotional burden.
timeFrame: At day one of the intervention
measure: Emotional distress
timeFrame: At day one of the intervention
measure: Daily life Performance
timeFrame: At day one of the intervention
measure: Number of sessions
timeFrame: At the end of the six sessions(each session is every three days)
measure: Quality of life.
timeFrame: At the end of the six sessions(each session is every three days)
measure: Caregiver emotional burden.
timeFrame: At the end of the six sessions(each session is every three days)
measure: Emotional distress
timeFrame: At the end of the six sessions(each session is every three days)
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario La Paz. Universidad Autónoma de Madrid
name: Beatriz Rodriguez Vega
role: STUDY_CHAIR
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