Cancer Clinical Trial
Official title:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|