Rare Diseases

All Conditions

Chronic Graft Versus Host Disease

Participants will receive individual logotherapy counseling by the investigator for 8 visits in 4 weeks.

Logotherapy is a method of finding meaning with three basic principles. The first principle is that life is meaningful in every situation , even in the most desperate moments. The second principle is that the main source of motivation is the desire to find meaning in life. The third is that an individual is free to choose his own attitude even in the worst conditions.

Logotherapy

Yasemin Eskigülek

Sultan Kav

The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.

Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow

The Effect of Logotherapy Counseling Programme on Dignity and Chronic Sorrow in Palliative Care Patients Experiencing Chronic Sorrow

Meaning in life scale is a validated, 7-points Likert type scale with 2 dimensions. Possible scores range from 5 to 35 for each dimensions. Change= score of present meaning subscale\> searched meaning subscale (8 week subscale-baseline subscale

The Patient Dignity Inventory is a valid, 5-points Likert type scale with 5 dimensions. Possible scores range from 25-125. Change= Lower score from the patient dignity inventory at the end of intervention compared to baseline.

Prolonged grief disorder scale-patient form is a valid, 5-points Likert type scale. Possible scores range from 12 to 60. Change= Lower score from the scale at the end of intervention compared to baseline.

Baskent University

RN, MSN

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.

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.

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.

Meaning-Centered Group Psychotherapy (MCP).

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.

Cognitive Behavioral Psychotherapy (CBT).

Pilar Llombart, Ph.D.Student

Sandra Perez, Ph.D.

Veronica Guillen Botella, Ph.D.

Joaquin Garcia-Alandete, Ph.D.

Rosa Baños, Ph.D.

Jose Heliodoro Marco Salvador, Ph. D.

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.

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

Spanish Meaning-Centered Psychotherapy for Cancer

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

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.

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).

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).

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).

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 \[39\].

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.)

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).

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".

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).

. 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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow	NCT05129059	Palliative Care Cancer	Logotherapy	18 Years -	Baskent University
Spanish Meaning-Centered Psychotherapy for Cancer	NCT05197348	Cancer	Meaning-Centere... Cognitive Behav...	18 Years -	University of Valencia

Spots Global Cancer Trial Database for meaning in life