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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492073
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: November 14, 2016
• Est. completion date: December 20, 2018

Study information

• Verified date: December 2017
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Emotional Supportive Mindfulness-based Program
Mindfulness training
• Emotional Supportive Program
Narrative-orientated therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

References & Publications (10)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. — View Citation

Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. Review. — View Citation

Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment. 2008 Jun;15(2):204-23. doi: 10.1177/1073191107311467. Epub 2008 Jan 9. — View Citation

Carlson LE. Mindfulness-based interventions for physical conditions: a narrative review evaluating levels of evidence. ISRN Psychiatry. 2012 Nov 14;2012:651583. doi: 10.5402/2012/651583. Print 2012. — View Citation

Fallowfield L, Jenkins V. Psychosocial/survivorship issues in breast cancer: are we doing better? J Natl Cancer Inst. 2014 Nov 27;107(1):335. doi: 10.1093/jnci/dju335. Print 2015 Jan. Review. — View Citation

Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6. Review. — View Citation

Gil F, Grassi L, Travado L, Tomamichel M, Gonzalez JR; Southern European Psycho-Oncology Study Group. Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients. Support Care Cancer. 2005 Aug;13(8):600-6. Epub 2005 Mar 11. — View Citation

Gort AM, March J, Gómez X, de Miguel M, Mazarico S, Ballesté J. [Short Zarit scale in palliative care]. Med Clin (Barc). 2005 May 7;124(17):651-3. Spanish. — View Citation

Hewitt M, Breen N, Devesa S. Cancer prevalence and survivorship issues: analyses of the 1992 National Health Interview Survey. J Natl Cancer Inst. 1999 Sep 1;91(17):1480-6. — View Citation

Lotfi-Jam K, Carey M, Jefford M, Schofield P, Charleson C, Aranda S. Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review. J Clin Oncol. 2008 Dec 1;26(34):5618-29. doi: 10.1200/JCO.2007.15.9053. Epub 2008 Nov 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mindfulness	Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.	At day one of the intervention
Primary	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	Quality of life.	Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL).	At day one of the intervention
Secondary	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
Secondary	Emotional distress	Distress thermometer (DT), scores from 1 to 10. Emotional distress.	At day one of the intervention
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)