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

April 16, 2019 updated by: Instituto de Investigación Hospital Universitario La Paz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotional Supportive Mindfulness-based Program

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
Mindfulness training
Active Comparator: Emotional Supportive Program

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
Narrative-orientated therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness
Time Frame: At day one of the intervention
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
At day one of the intervention
Mindfulness
Time Frame: At the end of the six sessions(each session is every three days)
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.
Time Frame: At day one of the intervention
Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL).
At day one of the intervention
Caregiver emotional burden.
Time Frame: At day one of the intervention
Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations.
At day one of the intervention
Emotional distress
Time Frame: At day one of the intervention
Distress thermometer (DT), scores from 1 to 10. Emotional distress.
At day one of the intervention
Daily life Performance
Time Frame: At day one of the intervention
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
Time Frame: At the end of the six sessions(each session is every three days)
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.
Time Frame: At the end of the six sessions(each session is every three days)
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.
Time Frame: At the end of the six sessions(each session is every three days)
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
Time Frame: At the end of the six sessions(each session is every three days)
Distress thermometer (DT), scores from 1 to 10. Emotional distress.
At the end of the six sessions(each session is every three days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Study Chair: Beatriz Rodriguez Vega, Hospital Universitario La Paz. Universidad Autónoma de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2016

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Emotional Supportive Mindfulness-based Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe