Spanish Meaning-Centered Psychotherapy for Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: a Protocol Study of a Randomized Control Trial

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Meaning-Centered Group Psychotherapy (MCP).
* Behavioral: Cognitive Behavioral Psychotherapy (CBT).


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial, efficacy Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meaning-Centered Group Psychotherapy (MCP).<br>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).<br>* 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.<br>|
| Active Comparator: Cognitive Behavioral Psychotherapy (CBT).<br>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).<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Anxiety Severity and Impairment Scale (OASIS) | The OASIS is a five-item instrument that assesses the frequency and intensity of anxiety symptoms during the past week. In addition, it measures interference in work and academic, social, and daily life domains, as well as avoidance behaviors. The items are rated on a Likert-type scale (0-4). The psychometric properties are good in terms of internal consistency (α= 0.86), convergent and discriminant validity, and sensitivity to change (α= 0.86). | 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) | The ODSIS is a six-item questionnaire that assesses the frequency and intensity of depression symptoms during the past week. In addition, it measures interference in work and academic, social, and daily life domains, as well as avoidance behaviors. The items are rated on a Likert-type scale (0-4). The psychometric properties are good in terms of internal consistency (α= 0.93). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Hopelessness Scale (HS) | It is a questionnaire that measures the level of hopelessness. It is made up of 20 items with dichotomous responses (True or False). It presents adequate internal consistency (α= 0.93) and has been validated in the Spanish population [39]. | 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) | The questionnaire includes 20 adjective items, 10 assessing positive affect (PANAS-P) and 10 assessing negative affect (PANAS-N). Respondents are asked to rate the extent to which they experienced each emotion within a specified time period, using a 5-point scale (1 = Very slightly or not at all; 5 = Very much). Both affect subscales showed adequate internal consistency: PANAS-P, (α = .89) and PANAS-N (α = .91.) | 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) | It is a 10-item index of perceived quality of life. It refers to physical and emotional well-being, functioning at work, personal relationships, self-independence, support in the community and from an emotional point of view, spiritual well-being, and overall perceived quality of life. The items are rated on a Likert scale (0-10) where higher scores indicate higher perceived quality of life. The psychometric properties are good for both internal consistency (α = .89) and test-retest reliability (r = 0.87). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Opinion and Expectations of Treatment Scale (OTSM) | This scale was designed and developed by members of the research team, based on an adaptation of another opinion and expectations questionnaire. The constructs this scale assesses are: opinion, acceptance and satisfaction with the skills training program, and changes in the participants after completing each module. The questions refer to the rationale for the intervention, recommendations for the program, satisfaction with the program, and usefulness and expectations of the skills training. The items are rated on a Likert-type scale ranging from 0 Not at all to 10 Very much. | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Mini-Mental Adjustment to Cancer Scale. | This scale evaluates the different ways of coping in cancer patients. It is a self-rating questionnaire made up of 29 items that measure five dimensions of coping: fighting spirit, helplessness-hopelessness, anxious preoccupation, fatalism, and cognitive avoidance. The items are rated on a Likert scale (1-4). The Spanish version of the MINIMAC [46] showed good psychometric properties for all the subscales (fighting spirit α = .60, helplessness-hopelessness α = .82, anxious preoccupation α = .90, fatalism α = .70, and cognitive avoidance α = .80). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| The Posttraumatic Growth Inventory (PTGI) | . The PTGI is a 21-item questionnaire that assesses the perception of personal benefits in survivors of a traumatic event. A Likert response format with six categories is used, with scores ranging from 0 (no change) to 5 (very high degree of change) in a positive sense; the higher the score, the greater the change perceived. The PTGI is composed of five dimensions: Relating to others, New possibilities, Personal strength, Spiritual change and a better understanding of spiritual matters and stronger religious beliefs, and a new appreciation of life. The PTGI shows good internal consistency (α = .80). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meaning Centered Psychotherapy, Cancer survivors, Meaning in Life, Cognitive Behavioral Therapy, Randomized Control Trial