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Determining the Spiritual Well-Being and Needs of Latino Cancer Patients

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ClinicalTrials.gov Identifier: NCT04015609
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Lincoln Medical and Mental Health Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to determine the extent to which spirituality, including meaning-making and faith, are associated with psychological adjustment (anxiety and depression), as well as the degree of hopelessness, and quality of life in Latinos diagnosed with advanced cancer.

Condition or disease Intervention/treatment
Solid Tumor Solid Tumor, Adult Solid Tumor, Unspecified, Adult Behavioral: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale Behavioral: Hospital Anxiety and Depression Scale Behavioral: Provider Interviews Behavioral: Participants Interviews

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Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Spiritual Well-Being and Needs of Latino Cancer Patients
Actual Study Start Date : April 20, 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Phase 1
Spanish speaking participants with Stage III or Stage IV solid cancer diagnosis
Behavioral: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale
Determines participant's spiritual well-being, including meaning-making and faith
Other Name: FACIT-sp-12

Phase 2
Spanish speaking participants with Stage III or Stage IV solid cancer diagnosis who are psychologically distressed
Behavioral: Hospital Anxiety and Depression Scale
Determines participant's anxiety and depression
Other Name: HADS

Phase 3
Participants are Mental Health Providers of Latino Cancer Patients and who are Spanish speaking
Behavioral: Provider Interviews
Mental health care providers will be interviewed and provide provider feedback to identify needed adaptations for Spanish speaking advanced cancer patients

Phase 4
Participants are Spanish Speaking + Advanced Cancer Diagnosis
Behavioral: Participants Interviews
Participants will be interviewed to assess the comprehensibility and acceptability of the adapted Individual Meaning Centered Psychotherapy (IMCP) manual




Primary Outcome Measures :
  1. Change in spiritual well being scores as measured by the FACIT-SP from baseline [ Time Frame: 1 year ]
    Spiritual well being scores are measured with the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited at MSKCC and LMC. All recruitment at LMC will be done by MSKCC research staff (CRCs) who hold affiliation with the participating site.
Criteria

Inclusion Criteria:

Eligible patients (phase 1 and 4):

  • Diagnosed with staged 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)

Qualitative/Phase 2:

  • Enrolled in the quantitative phase of study (as seen above)
  • Completed the quantitative phase questionnaire package
  • Scored 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

Key Informant Feedback/Phase 3:

Eligible providers are:

  • Professionals working in the mental health field;
  • Have a caseload of fie or more Latino cancer patients per month
  • Able to communicate and read in Spanish
  • Agrees to be audio or video-recorded

Exclusion Criteria:

  • 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 measure (patients whose psychiatric disorder is well controlled by treatment will be eligible)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015609


Contacts
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Contact: Rosario Costas-Muniz, PhD 646-888-8062 costasmr@mskcc.org
Contact: William Breitbart, MD 646-888-0020 breitbaw@mskcc.org

Locations
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United States, New York
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States
Contact: Caroline Hwang, MD    718-579-5000      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Rosario Costas-Muniz, PhD    646-888-8062      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Lincoln Medical and Mental Health Center
Investigators
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Principal Investigator: Rosario Costas-Muniz, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04015609     History of Changes
Other Study ID Numbers: 15-076
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Stage III solid tumor cancer
Stage IV solid tumor cancer
Stage III cancer
Stage IV cancer
Spanish
Memorial Sloan Kettering Cancer Center
15-076

Additional relevant MeSH terms:
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Neoplasms