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CancerNCT05197348

Spanish Meaning-Centered Psychotherapy for Cancer

A study testing Meaning-Centered Group Psychotherapy (MCP). and Cognitive Behavioral Psychotherapy (CBT). in people with Cancer, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Meaning-Centered Group Psychotherapy (MCP). and Cognitive Behavioral Psychotherapy (CBT).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSpain
Study dates
2 Jan 2021to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

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

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.

Read the 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

Conditions
Cancer
Being tested
Meaning-Centered Group Psychotherapy (MCP)., Cognitive Behavioral Psychotherapy (CBT).
Keywords
Meaning Centered Psychotherapy, Cancer survivors, Meaning in Life, Cognitive Behavioral Therapy, Randomized Control Trial
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meaning-Centered Group Psychotherapy (MCP).Behavioural

    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.

  • Cognitive Behavioral Psychotherapy (CBT).Behavioural

    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.

Study groups in NCT05197348
Study groupRoleWhat they receive
Meaning-Centered Group Psychotherapy (MCP).ExperimentalThe 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.
Receives: Behavioral: Meaning-Centered Group Psychotherapy (MCP).
Cognitive Behavioral Psychotherapy (CBT).Active comparatorThe 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.
Receives: Behavioral: Cognitive Behavioral Psychotherapy (CBT).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

Secondary outcomes (8)

  1. 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).

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

  2. 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).

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

  3. 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].

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

  4. 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.)

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

  5. 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).

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

  6. 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".

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

  7. 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).

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

  8. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start2 Jan 2021
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial, efficacy Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05197348
Sponsor's protocol ID
CEIM:2019-17
Status last verified
Dec 2022
First submitted
4 Jan 2022
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32881109

  • 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.

    PubMed 11147988

  • 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.

    PubMed 28374663

  • 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.

    PubMed 30246682

  • 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.

    PubMed 22370330

  • 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.

    PubMed 27435603

  • 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.

    PubMed 30683164

  • 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.

    PubMed 34388037

  • 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.

    PubMed 39174266

  • 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.

    PubMed 35873227

Questions about this trial

What is this clinical trial studying?

A study testing Meaning-Centered Group Psychotherapy (MCP). and Cognitive Behavioral Psychotherapy (CBT). in people with Cancer, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Meaning in Life Questionnaire (MLQ) (time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05197348, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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