Psychotherapy Intervention for Latinos With Advanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. Cancer affects patients and their loved ones. Latinos often experience greater challenges due to the cancer. However, few studies and interventions focus on Latinos. We are interested in understanding what affects Latino patients' quality of life, and how to improve it
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with stages III or IV solid tumor cancer *(as per self report for ICCAN patients)
Age 18 or older
As per self report, Latino/a or Hispanic ethnicity
As per self report, fluent in oral Spanish (monolingual) or fluent in oral Spanish and English (bilingual)
Disqualifiers
In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
In the judgment of the consenting professional, significant or major disabling medical or psychiatric condition sufficient to preclude meaningful informed consent, interview, or completion of assessment measures (patients whose psychiatric disorder is well controlled by treatment will be eligible)
In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
In the judgment of the consenting professional, significant or major disabling medical or psychiatric condition sufficient to preclude meaningful informed consent, interview, or completion of assessment measures (patients whose psychiatric disorder is well controlled by treatment will be eligible)
Trial design
Design model
Parallel
Treatments tested in this trial
Meaning Centered Psychotherapy for Latinos
BehavioralMCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span ot 7-14 weeks.
Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale
BehavioralDetermines the degree of spiritual well-being
Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients
BehavioralWaitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.
Pre-assessment questionnaire
BehavioralWhich includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Meaning Centered Psychotherapy for Latinos (MCP-L)Experimental treatment 4 interventions
Group B: ControlActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale
FACIT Spiritual Well-Being Scale is a brief self-report measure designed to assess the nature and extent of individual spiritual well-being. This measure, which generates two sub-scales, one corresponding to Faith (the importance of faith and spirituality) and a second assessing Meaning-Peace (one sense of meaning and purpose in life), has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha equals .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). In additional, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations.
Time frame
Change from baseline to post assessment 7-14 weeks afterSecondary outcomes
1
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a validated scale used to measure anxiety and depression. This scale has been validated against structured or semi-structured clinical interviews, the gold standard for the assessment of mental disorders, in a significant number of studies. Further strengths of this scale for the assessment of emotional distress in cancer patients stem from the joint assessment of anxiety and depressive symptoms without referring to physical symptoms of anxiety or depression. Given the high comorbidity of anxiety of cancer as well as the systematic exclusion of confounding physical symptoms, the scale seems especially appropriate for use in this patient group. The HADS consists of 14 items which reflect a 7-item anxiety and a 7-item depression subscale. This scale has sound psychometric properties in Spanish.
Time frame
Change from baseline to post assessment 7-14 weeks after2
Hopelessness measured with the Beck Hopelessness Scale
The Beck Hopelessness Scale (BHS) comprises 20 true/false questions that assess degree of pessimism and hopelessness. Several studies have demonstrated a high degree of internal consistency and construct validity. Scores ranging from 4 to 8 typically indicate a "mild" degree of hopelessness, 9 to 12 correspond to "moderate" hopelessness, and scores about 12 reflect "severe" levels of hopelessness.
Time frame
Change from baseline to post assessment 7-14 weeks after3
Quality of life measured with the FACIT Spiritual Well-Being Scale
The FACIT Spiritual Well-Being Scale (FACIT-Sp-12) is a brief self-report measure designed to assess the nature and extent of individual's spiritual well-being. This measure (range 0-48), which generates two sub-scales, Faith (the importance of faith/spirituality, range 0-16) and Meaning /Peace (one's sense of meaning and purpose in life, range 0-32). The total score for the FACIT-Sp scale is the sum of the two subscales Faith and Meaning /Peace. It has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha = .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). Higher scores represent a higher level of spiritual well-being, faith or meaning-peace. In addition, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations. Administration time takes approximately 4 minutes.
Time frame
Change from baseline to post assessment 7-14 weeks afterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Lincoln Medical and Mental Health Center
Collaborator
Source ClinicalTrials.gov