Clinical trial · Interventional
Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
NCT03492073CI-TRIAL-00038172completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emotional Supportive Mindfulness-based Program | Behavioral | — | UNRESOLVED |
| Emotional Supportive Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Emotional Supportive Mindfulness-based Program
- description
- 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.
- interventionNames
- Behavioral: Emotional Supportive Mindfulness-based Program
- type
- ACTIVE_COMPARATOR
- label
- Emotional Supportive Program
- description
- 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.
- interventionNames
- Behavioral: Emotional Supportive Program
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDFallowfield 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. PMID 25432407
- BACKGROUNDHewitt 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. PMID 10469749
- BACKGROUNDAlfano 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. PMID 17034679
- BACKGROUNDFors 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. PMID 20821803
- BACKGROUNDLotfi-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. PMID 18981466
- BACKGROUNDCarlson 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. PMID 23762768
- BACKGROUNDGil 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.