Spots Global Cancer Trial Database for Spanish Meaning-Centered Psychotherapy for Cancer
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Trial Identification
Brief Title: 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 ID: NCT05197348
Conditions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
University of Valencia, Valencia, , Spain
Contact Details
Name: Pilar Llombart, Ph.D.Student
Affiliation: Valencian Institute of Oncology Foundation (IVO)
Role: PRINCIPAL_INVESTIGATOR
Name: Sandra Perez, Ph.D.
Affiliation: University of Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Veronica Guillen Botella, Ph.D.
Affiliation: University of Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Joaquin Garcia-Alandete, Ph.D.
Affiliation: University of Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Rosa Baños, Ph.D.
Affiliation: University of Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Jose Heliodoro Marco Salvador, Ph. D.
Affiliation: University of Valencia
Role: STUDY_CHAIR
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