Cancer Clinical Trial
Official title:
Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: a Protocol Study of a Randomized Control Trial
Verified date | December 2022 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 (? = 91), Purpose (? = 92), and Mattering (? = 86). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | |
Secondary | 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 (a= 0.86), convergent and discriminant validity, and sensitivity to change (a= 0.86). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | |
Secondary | 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 (a= 0.93). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | |
Secondary | 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 (a= 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. | |
Secondary | 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, (a = .89) and PANAS-N (a = .91.) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | |
Secondary | 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 (a = .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. | |
Secondary | 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. | |
Secondary | 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 a = .60, helplessness-hopelessness a = .82, anxious preoccupation a = .90, fatalism a = .70, and cognitive avoidance a = .80). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | |
Secondary | 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 (a = .80). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. |
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