Clinical trial NCT05197348: Spanish Meaning-Centered Psychotherapy for Cancer
Official title: Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: a Protocol Study of a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Meaning Centered Psychotherapy
Cancer survivors
Meaning in Life
Cognitive Behavioral Therapy
Randomized Control Trial
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial, efficacy Study
Primary purpose: TREATMENT

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.

Detailed description: Meaning-Centered Psychotherapy (MCP) is effective in improving meaning in life, hope, optimism, self-efficacy, well-being, and quality of life, and in reducing stress in people with cancer. However, all the studies on the application of MCP in cancer patients have been carried out in Anglo-Saxon samples. Therefore, it is necessary to adapt and verify the efficacy of MCP in populations that speak languages other than English, such as Spanish. Moreover, to expand the data supporting the efficacy of MCP for cancer patients, it would be necessary to compare MCP to other active therapies such as Cognitive Behavioral Therapy (CBT). The study has several aims: The first objective is to verify the efficacy of the MCP intervention for Spanish participants with cancer in a randomized control trial (RCT) comparing it to CBT. The second objective is to analyze the feasibility and acceptance of MCP in Spanish participants with cancer. The third objective is to analyze whether the changes produced in the Meaning in Life dimensions (presence, search, comprehension, purpose, and mattering) will predict changes in anxiety, depression, quality of life, etc.

The investigators adapted MCP for Spanish participants with cancer. The Spanish MCP is an adaptation of the MCP developed by Breitbart as an eight-session group therapy for patients with advanced cancer. This paper presents the study protocol. The study design consists of a two-arm RCT with two conditions: MCP and CBT, where participants will be randomized to one of the two groups. Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Meaning in Life Questionnaire (MLQ)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: The Multidimensional Existential Meaning Scale (MEMS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Secondary outcomes:
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Hopelessness Scale (HS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Quality of life index-Spanish version (QLI)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Opinion and Expectations of Treatment Scale (OTSM)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Mini-Mental Adjustment to Cancer Scale.
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: The Posttraumatic Growth Inventory (PTGI)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Valencian Institute of Oncology Foundation (IVO)
name: Pilar Llombart, Ph.D.Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Sandra Perez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Veronica Guillen Botella, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquin Garcia-Alandete, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Rosa Baños, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Jose Heliodoro Marco Salvador, Ph. D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.