Cognitively-Based Compassion Training for Breast Cancer Survivors

NCT03305952 | Unknown DMC

• 1 other identifier: CBCT-IVO
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

There is a growing number of evidence of how mindfulness training enhances psychological and physical well-being and coping strategies in patients with oncological illnesses. However, there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast cancer survivors. The goal of this study is to analyze enrollment, participant satisfaction and adherence to program and differences in psychological well-being, health related quality of life, fear of illness recurrence, compassion and self-compassion variables after a Compassion-Based Intervention in a Spanish breast cancer survivor sample. This study is a randomized clinical trial of a secularized intervention called Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT intervention condition were asked to meet weekly for a two (2) hour long session during two months. Pre-post-intervention and six month follow-up measures took place to evaluate: psychological well-being (somatic, depressive, and anxious symptomatology), health related quality of life (physical, social, emotional, and functional); psychological stress, coping strategies and triggering cognitions linked to cancer recurrence fear, self-compassion, compassion and mindfulness and awareness in both intervention and wait list groups. CBCT is a promising and potentially useful intervention to enhance physical and emotional well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and a process of cultural adaptation required.

Conditions

Compassion; Treatment as Usual

Outcome Measures

Primary Outcomes (1)

• Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4)

  Designed to assess health related quality of life in breast cancer. Consists of 37 items and respondents are asked to indicate on a scale from 0 (not at all) through 4 (very much). Composed by five factors: physical quality of life; social / family and social quality of life; emotional quality of life; functional quality of life; and other concerns. FACT-B+4 has shown to have good. (Brady et al., 1997; Belmonte Martinez et al., 2011)

  8 weeks, 6 months

Secondary Outcomes (5)

• Change Brief Symptom Inventory [BSI-18]

  8 weeks, 6 months

• Change Self-Compassion Scale-Short Form (SCS-SF)

  8 weeks, 6 months

• Change in The Compassion Scale (CS)

  8 weeks, 6 months

• Change in Five Facets of Mindfulness Questionnaire - short form (FFMQ-SF)

  8 weeks, 6 months

• Change in Fear of Cancer Recurrence Inventory (FCRI)

  8 weeks to six months

Other Outcomes (8)

• High attendance (6 sessions) with protocol (CBCT® Evaluation Survey)

  8 weeks

• High minutes of home practice (CBCT® Evaluation Survey)

  8 weeks

• High percentage of home practice with recordings (CBCT® Evaluation Survey)

  8 weeks

Study Arms (2)

Compassion

EXPERIMENTAL

CBCT was facilitated in an eight weekly, 2-h sessions format through didactics, class discussion, and guided meditation practice. Topics covered in order were: Week 1: Developing attention stability and mental clarity. Week 2. Open awareness of sensations, feelings, and emotions. Week 3: Self-Compassion. Week 4: Practice in impartiality and cultivation of social connection. Week 5: Practice in appreciation, gratitude, social interconnection, and interdependence. Session 6: Practice in affection (endearment) for developing undifferentiated affection for others. Week 7: Development of the aspirational wish that all beings be happy and free from suffering and its causes. Week 8: Active compassion

Behavioral: CBCT

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual (TAU) consisted of usual periodical visits to psycho oncologist based on hospital's regular calendar. Hospital's standard treatment was applied to participants. The standard treatment consists of counselling interventions, cognitive-behavioural interventions, family interventions, third generation interventions.

Other: TAU

Interventions

CBCT BEHAVIORAL

Compassion

TAU OTHER

Treatment as usual

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged between 35 and 75 years,
• Being able to read and write using the Spanish language,
• History of treated Breast Cancer within the past 15 years,
• Free from oncological illness
• Not receiving any kind of chemotherapy and / or radiotherapy treatment during study.
• Eligible participants were contacted by their personal psychooncologist either by a telephone call or at psychooncology appointment periodical visit to invite them to an explanatory meeting of the study.

You may not qualify if:

• Active severe mental disorders (schizophrenia, bipolar disorder, eating disorders, and major depression),
• Substance use disorders, cognitive impairment,
• Impaired medical condition.
• Past and current psychiatric and medical history was determined by clinician assessment with the Mini International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997) Spanish version (Lobo et al., 1999).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Fundación Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Related Publications (38)

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  BACKGROUND

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• Thewes B, Butow P, Bell ML, Beith J, Stuart-Harris R, Grossi M, Capp A, Dalley D; FCR Study Advisory Committee. Fear of cancer recurrence in young women with a history of early-stage breast cancer: a cross-sectional study of prevalence and association with health behaviours. Support Care Cancer. 2012 Nov;20(11):2651-9. doi: 10.1007/s00520-011-1371-x. Epub 2012 Feb 11.

  PMID: 22328003 RESULT

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  PMID: 24307136 RESULT

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

  PMID: 26742998 RESULT

• Sansó, N., Galiana, L., Cebolla, A., Oliver, A., Benito, E., & Ekman, E. (2017). Cultivating emotional balance in professional caregivers: A pilot intervention. Mindfulness, , 1-9.

  RESULT

• Gonzalez-Hernandez E, Romero R, Campos D, Burychka D, Diego-Pedro R, Banos R, Negi LT, Cebolla A. Cognitively-Based Compassion Training (CBCT(R)) in Breast Cancer Survivors: A Randomized Clinical Trial Study. Integr Cancer Ther. 2018 Sep;17(3):684-696. doi: 10.1177/1534735418772095. Epub 2018 Apr 22.

  PMID: 29681185 DERIVED

Related Links

• Weiss, M. C. (2017). U.S. breast cancer statistics.

Study Officials

• Edgar Gonzalez-Hernandez

  Universitat de València

  PRINCIPAL INVESTIGATOR

• Rebeca Diego Pedro, PhD

  Universitat de València

  PRINCIPAL INVESTIGATOR

• Rocío Romero Retes, PhD

  Fundación Instituto Valenciano de Oncología

  PRINCIPAL INVESTIGATOR

• Daniel Campos Bacas, PhD

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Lobsang Tenzin Negi aka Satya Dev Negi, PhD

  Emory University / Emory-Tibet Partnership

  PRINCIPAL INVESTIGATOR

• Diana Burichka

  Universitat de València

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ausiàs Cebolla Martí, PhD

CONTACT

+34 96 386 44 07; ausias.cebolla@uv.es

Rosa Baños Rivera, PhD

CONTACT

+34 96 386 44 12; Rosa.Banos@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 10, 2017
• Study Start: January 11, 2016
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

ES (1)