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Completed

NCT Number: NCT03492073

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emotional Supportive Mindfulness-based Program

Behavioral

Mindfulness training

Emotional Supportive Program

Behavioral

Narrative-orientated therapy.

Primary outcomes

  1. Mindfulness

    Time frame: At day one of the intervention

    Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.

  2. 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.

Secondary outcomes

  1. Quality of life.

    Time frame: At day one of the intervention

    Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL).

  2. 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.

  3. Emotional distress

    Time frame: At day one of the intervention

    Distress thermometer (DT), scores from 1 to 10. Emotional distress.

  4. 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.

  5. 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

  6. 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).

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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