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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotional Supportive Mindfulness-based Program | Experimental | 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. |
|
| Emotional Supportive Program | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional Supportive Mindfulness-based Program | Behavioral | Mindfulness training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness | Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance. | At day one of the intervention |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life. | Quality of life in advanced-cancer patients. (EORTC QLQ - C15-PAL). | At day one of the intervention |
| Caregiver emotional burden. | Zarit. Emotional burden of the main caregiver. Impact of caring, interpersonal relationship and self-efficacy expectations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz Rodriguez Vega | Hospital Universitario La Paz. Universidad Autónoma de Madrid | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25432407 | Background | 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. | |
| 10469749 | Background | 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. doi: 10.1093/jnci/91.17.1480. |
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| Emotional Supportive Program | Behavioral | Narrative-orientated therapy. |
|
| At day one of the intervention |
| Emotional distress | Distress thermometer (DT), scores from 1 to 10. Emotional distress. | At day one of the intervention |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 17034679 | Background | Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012. |
| 20821803 | Background | 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. |
| 18981466 | Background | 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. |
| 23762768 | Background | 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. |
| 15761700 | Background | 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. doi: 10.1007/s00520-005-0780-0. Epub 2005 Mar 11. |
| 8433390 | Background | 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. doi: 10.1093/jnci/85.5.365. |
| 15882512 | Background | Gort AM, March J, Gomez X, de Miguel M, Mazarico S, Balleste J. [Short Zarit scale in palliative care]. Med Clin (Barc). 2005 May 7;124(17):651-3. doi: 10.1157/13074742. Spanish. |
| 18187399 | Background | 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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