Spanish Meaning-Centered Psychotherapy for Cancer

NCT05197348 | Completed

• 1 other identifier: CEIM:2019-17
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to verify the efficacy of the Spanish adaptation of Meaning-Centered Psychotherapy for Spanish participants with cancer in a randomized control trial.

Conditions

Cancer

Keywords

Meaning Centered Psychotherapy; Cancer survivors; Meaning in Life; Cognitive Behavioral Therapy; Randomized Control Trial

Outcome Measures

Primary Outcomes (2)

• Meaning in Life Questionnaire (MLQ)

  The MLQ is a self-reported questionnaire made up of 10 items, and it was developed to assess the two main dimensions of meaning in life: presence and search for meaning in life. The items are rated on a 7-point scale ranging from 1 (absolutely false) to 7 (absolutely true). The factors of Presence and Search were correlated (r = -.19), and internal consistency was good for Presence (.86) and Search (.87). One-month test-retest reliability coefficients were .70 for Presence and .73 for Search.

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

• The Multidimensional Existential Meaning Scale (MEMS)

  The MEMS assesses the meaning in life dimensions: Comprehension, purpose, and mattering, with a total of 15 items. Likert type responses are given on a 7-point scale (1 = Very strongly disagree; 7 = Very strongly agree). The three MEMS subscales showed adequate internal consistency: Comprehension (ϖ = 91), Purpose (ϖ = 92), and Mattering (ϖ = 86).

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

Secondary Outcomes (8)

• Overall Anxiety Severity and Impairment Scale (OASIS)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

• Overall Depression Severity and Impairment Scale (ODSIS)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

• Hopelessness Scale (HS)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

• The Positive and Negative Affect Schedule (PANAS)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

• Quality of life index-Spanish version (QLI)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

Study Arms (2)

Meaning-Centered Group Psychotherapy (MCP).

EXPERIMENTAL

The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis. The investigators will follow the manualized MCP for patients with advanced cancer.

Behavioral: Meaning-Centered Group Psychotherapy (MCP).

Cognitive Behavioral Psychotherapy (CBT).

ACTIVE COMPARATOR

The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis, with the following sessions. The investigators will follow the manualized CBT or patients with advanced cancer.

Behavioral: Cognitive Behavioral Psychotherapy (CBT).

Interventions

Meaning-Centered Group Psychotherapy (MCP). BEHAVIORAL

The MCP program is divided into eight sessions: Session1: Psychoeducation about Meaning in life, Sources of Meaning, etc. Session 2: Cancer illness and meaning. Session 3: Historical Sources of Meaning (the past) Session 4: Historical Sources of Meaning (present and future). Session 5: Attitudinal Sources of Meaning. Session 6: Creative Sources of Meaning. Session 7: Experimental Sources of Meaning. Session 8: End of psychotherapy, farewell, and facing the future with hope.

Meaning-Centered Group Psychotherapy (MCP).

Cognitive Behavioral Psychotherapy (CBT). BEHAVIORAL

The CBT divided into eight sessions: Session1: Presentation of psychotherapy, establishing the goals of psychotherapy. Presentation of the participants. Updated information about psychological consequences of cancer. Session 2. Increase in enjoyable activities. Behavioral activation. Progressive muscle relaxation training. Slow breathing training. Session 3. Cognitive model of coping with cancer. Psychoeducation on negative thoughts. Training in detecting negative thoughts. Presentation of cognitive distortions Session 4. Training in cognitive restructuring techniques. Session 5. Training in problem-solving skills. Session 6. Being aware of participants needs. Self-care. Assertiveness skills training. Session 7. Setting goals for the future. Session 8. Summary, relapse prevention, and end of psychotherapy.

Cognitive Behavioral Psychotherapy (CBT).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy).
• Participants will have to express a need for psychological care.
• Participants will have low meaning in life.

You may not qualify if:

• Participants who are currently receiving another psychological or psychiatric treatment.
• Diagnosis of a serious mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (10)

• Marco JH, Alonso S, Banos R. Meaning-making as a mediator of anxiety and depression reduction during cognitive behavioral therapy intervention in participants with adjustment disorders. Clin Psychol Psychother. 2021 Mar;28(2):325-333. doi: 10.1002/cpp.2506. Epub 2020 Sep 10.

  PMID: 32881109 BACKGROUND

• Breitbart W, Rosenfeld B, Pessin H, Kaim M, Funesti-Esch J, Galietta M, Nelson CJ, Brescia R. Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. JAMA. 2000 Dec 13;284(22):2907-11. doi: 10.1001/jama.284.22.2907.

  PMID: 11147988 BACKGROUND

• van der Spek N, Vos J, van Uden-Kraan CF, Breitbart W, Cuijpers P, Holtmaat K, Witte BI, Tollenaar RAEM, Verdonck-de Leeuw IM. Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. Psychol Med. 2017 Aug;47(11):1990-2001. doi: 10.1017/S0033291717000447. Epub 2017 Apr 4.

  PMID: 28374663 BACKGROUND

• Vos J, Vitali D. The effects of psychological meaning-centered therapies on quality of life and psychological stress: A metaanalysis. Palliat Support Care. 2018 Oct;16(5):608-632. doi: 10.1017/S1478951517000931. Epub 2018 Sep 24.

  PMID: 30246682 BACKGROUND

• Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, Olden M, Pessin H, Lichtenthal W, Sjoberg D, Cassileth BR. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer. J Clin Oncol. 2012 Apr 20;30(12):1304-9. doi: 10.1200/JCO.2011.36.2517. Epub 2012 Feb 27.

  PMID: 22370330 BACKGROUND

• Rosenfeld B, Saracino R, Tobias K, Masterson M, Pessin H, Applebaum A, Brescia R, Breitbart W. Adapting Meaning-Centered Psychotherapy for the palliative care setting: Results of a pilot study. Palliat Med. 2017 Feb;31(2):140-146. doi: 10.1177/0269216316651570. Epub 2016 Jul 21.

  PMID: 27435603 BACKGROUND

• Lichtenthal WG, Catarozoli C, Masterson M, Slivjak E, Schofield E, Roberts KE, Neimeyer RA, Wiener L, Prigerson HG, Kissane DW, Li Y, Breitbart W. An open trial of meaning-centered grief therapy: Rationale and preliminary evaluation. Palliat Support Care. 2019 Feb;17(1):2-12. doi: 10.1017/S1478951518000925. Epub 2019 Jan 26.

  PMID: 30683164 BACKGROUND

• Winger JG, Ramos K, Kelleher SA, Somers TJ, Steinhauser KE, Porter LS, Kamal AH, Breitbart WS, Keefe FJ. Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. J Palliat Med. 2022 Jan;25(1):60-69. doi: 10.1089/jpm.2021.0081. Epub 2021 Aug 12.

  PMID: 34388037 BACKGROUND

• Marco JH, Llombart P, Romero R, Garcia-Conde A, Corral V, Guillen V, Perez S. Meaning-Centered Psychotherapy Versus Cognitive Behavioral Therapy for Cancer Survivors: A Randomized Controlled Trial☆. Behav Ther. 2024 Sep;55(5):1071-1083. doi: 10.1016/j.beth.2024.03.005. Epub 2024 Apr 10.

  PMID: 39174266 DERIVED

• Marco JH, Llombart P, Guillen V, Banos RM, Romero R, Garcia-Conde A, Perez Rodriguez S. Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: Study Protocol of a Randomized Control Trial. Front Psychiatry. 2022 Jul 7;13:892573. doi: 10.3389/fpsyt.2022.892573. eCollection 2022.

  PMID: 35873227 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pilar Llombart, Ph.D.Student

  Valencian Institute of Oncology Foundation (IVO)

  PRINCIPAL INVESTIGATOR

• Sandra Perez, Ph.D.

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Veronica Guillen Botella, Ph.D.

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Joaquin Garcia-Alandete, Ph.D.

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Rosa Baños, Ph.D.

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Jose Heliodoro Marco Salvador, Ph. D.

  University of Valencia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Phychology

Model Details: Randomized Control Trial, efficacy Study

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: January 2, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 26, 2026

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)