NCT03492073

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

April 17, 2019

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

December 4, 2017

Last Update Submit

April 16, 2019

Conditions

Cancer

Keywords

MindfulnessOncologyCancerEmotional distressQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (8)

  • Quality of life.

    At day one of the intervention

  • Caregiver emotional burden.

    At day one of the intervention

  • Emotional distress

    At day one of the intervention

  • Daily life Performance

    At day one of the intervention

  • Number of sessions

    At the end of the six sessions(each session is every three days)

  • +3 more secondary outcomes

Study Arms (2)

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.

Behavioral: Emotional Supportive Mindfulness-based Program

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.

Behavioral: Emotional Supportive Program

Interventions

Emotional Supportive Mindfulness-based ProgramBEHAVIORAL

Mindfulness training

Emotional Supportive Mindfulness-based Program
Emotional Supportive ProgramBEHAVIORAL

Narrative-orientated therapy.

Emotional Supportive Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 25432407BACKGROUND

  • 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.

    PMID: 10469749BACKGROUND

  • 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.

    PMID: 17034679BACKGROUND

  • 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.

    PMID: 20821803BACKGROUND

  • 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.

    PMID: 18981466BACKGROUND

  • 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.

    PMID: 23762768BACKGROUND

  • 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.

    PMID: 15761700BACKGROUND

  • 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.

    PMID: 8433390BACKGROUND

  • 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.

    PMID: 15882512BACKGROUND

  • 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.

    PMID: 18187399BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Beatriz Rodriguez Vega

    Hospital Universitario La Paz. Universidad Autónoma de Madrid

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

April 10, 2018

Study Start

November 14, 2016

Primary Completion

December 15, 2018

Study Completion

December 20, 2018

Last Updated

April 17, 2019

Record last verified: 2017-12