Solid Tumor Clinical Trial
Official title:
Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer
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
Status | Recruiting |
Enrollment | 285 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Phase I: Quantitative - 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) Phase 2: Qualitative - Enrolled in the quantitative phase of study (as seen above) - Completes the quantitative phase questionnaire - Scores above or below the threshold for the Distress Thermometer (DT=4 or =3) - In the judgment of the investigator, willing and able to be interviewed in Spanish only - Agrees to be audio- recorded Phase 3: Provider Feedback - Professionals working in the mental health field; - Have a caseload of five or more Latino cancer patients per month - Able to communicate and read in Spanish - Agrees to be audio or video-recorded Phase 4: Patient Feedback - 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 - In the judgment of the investigator, willing and able to be interviewed in Spanish only - Agrees to be audio-recorded Phase 5: Pilot RCT - Diagnosed with stages III or IV solid tumor cancer - Age 18 or older - Latino/a or Hispanic ethnicity - Fluent in oral Spanish (monolingual or bilingual) - Scores above the threshold for the Distress Thermometer (DT=4) - Agrees to be audio-recorded Exclusion Criteria: Phase 1: Quantitative - 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) Phase 2: Qualitative - 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) Phase 4: Patient Feedback - Diagnosed with a major disabling medical or psychiatric condition - Unable to understand the consent procedure - Too ill to participate, all as reported by the patient and/or determined by the investigator's judgment. Phase 5: Pilot RCT - Diagnosed with a major disabling medical - Diagnosed with a major disabling psychiatric condition - Unable to understand the consent procedure - Too ill to participate, all as reported by the patient and/or determined by the investigator's judgment |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Ponce Health Sciences University | Ponce | |
United States | Lincoln Medical and Mental Health Center | Bronx | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | MSK at Ralph Lauren | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Lincoln Medical and Mental Health Center |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from baseline to post assessment 7-14 weeks after | |
Secondary | 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. | Change from baseline to post assessment 7-14 weeks after | |
Secondary | 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. | Change from baseline to post assessment 7-14 weeks after | |
Secondary | 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. | Change from baseline to post assessment 7-14 weeks after |
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