- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112188
Meaning-Centered Counseling for Chinese Patients Who Are Being Treated for Advanced Cancer
Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer
Study Overview
Status
Conditions
Detailed Description
Phases 1 and 2: Formative Research and Adaptation This is a study to adapt the IMCP intervention to be culturally and linguistically tailored for Chinese cancer patients. This study will be carried out in two phases: 1) formative research and 2) adaptation. Preliminary formative research has begun in our study exploring community needs and priorities through exemption application X13-034. For this application we will continue the formative research (phase 1) by conducting 12 in-depth interviews with Chinese immigrants with advanced cancer to inform the adaptation of the intervention. Results of the patient in-depth interviews will inform how to adapt the IMCP process and session themes to reflect the needs of the community. In the adaptation phase (phase 2) the Breitbart IMCP research team (including Drs. Breitbart, Lichtenthal, and Applebaum), Drs. Leng, Gany, and Ms. Huang will discuss a priori adaptations to the intervention. Potential changes to the process and content will be discussed. Adaptations will be incorporated in a modified IMCP-Ch treatment manual, therapist checklist/outline and Treatment Integrity Coding Manual.
Phase 3: Feasibility Pilot This phase will feature an open feasibility study using a pretest vs. posttest design, with the intervention to be delivered via telehealth in Mandarin Chinese by a bilingual interventionist or by an English-speaking therapist in English (for bilingual Chinese and English-speaking patients who prefer English) or through English-to-Mandarin Remote Simultaneous Medical Interpretation (RSMI), depending on participants' preference
Added a new phase (Phase 4), to more rigorously examine the effects of using remote interpreting modalities to deliver IMCP to Chinese patients with advanced cancer; and (2) to add a minimum distress level for eligibility in order to align trial eligibility criteria with those employed in prior MCP trials, which used a DistressThermometer (DT) cutoff of >4 to identify patients with clinically significant distress (participants who do not meet this criteria will be enrolled in Phase 3). Phase 4 will employ a three-arm pilot randomized controlled trial (RCT) to test the feasibility and acceptability of using (1) Remote Consecutive Medical Interpretation (RCMI), (2) Remote Simultaneous Medical Interpretation (RSMI) and (3) bilingual provider (control/gold standard) in delivering IMCP-Ch.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francesca Gany, MD, MS
- Phone Number: 646-888-8054
Study Contact Backup
- Name: Florence Lui, PhD
- Phone Number: 646-888-8369
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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New York
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Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
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Contact:
- Francesca Gany, MD,MS
- Phone Number: 646-888-8054
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Principal Investigator:
- Florence Lui, PhD
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New York, New York, United States, 10035
- Recruiting
- MSK at Ralph Lauren (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8369
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Phase I participants will be recruited through MSKCC and referrals provided by Qcc, CCHC, ACS Asian Initiatives, CBWCHC, NYHQ and NYCAAMH and the Cheung and Kan Medical Group.
Phase 3 and 4 participants will be recruited through MSKCC and referrals provided by community clinicians/collaborating partners. Flyers (Phase 3, Appendix H) in Chinese announcing the study will be distributed through MSKCC and community organizations and hospitals (e.g., QCC, WCMC, NYP LMH, CCHC, ACS Asian Initiatives, CBWCHC, NYHQ, the Cheung and Kan Medical Group and NYCAAMH).
Description
Inclusion Criteria:
Phases 1 and 2:
Interview Inclusion Criteria (per self-report):
- Non-US born;
- Of Chinese descent;
- Age 21 years through 80 years;
- Language spoken: Mandarin and/or English
- Diagnosis of Stage IV cancer (any type).
Phase 3:
- Stage III or IV cancer (per self-report or on the MSKCC EMR). If traditional staging does not apply (i.e. for leukemia), we can allow patient deemed by provider to have poor prognosis/roughly equivalent to Stage III or IV to be referred.
- Age 18 or older
- Of Chinese descent
- Mandarin-speaking
- Have an estimated life expectancy of at least 6 months (per self-report or on the MSKCC EMR)
- Resides in New York State
Phase 4:
- Stage III or IV cancer (per self-report or on the MSKCC EMR). If traditional staging does not apply (i.e. for leukemia), we can allow patient deemed by provider to have poor prognosis/roughly equivalent to Stage III or IV to be referred.
- Age 18 or older
- Of Chinese descent
- Mandarin-speaking
- Have an estimated life expectancy of at least 6 months (per referring physician assessment or on the MSKCC EMR)
- Resides in New York State
- Score >or = to 4 on the Distress Thermomete
Exclusion Criteria:
Phases 1 and 2:
- Presence of cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection. The Chinese version of the Mini Mental State Examination (MMSE) (46) will be used as a cognitive screening tool. Patients with MMSE scores below 20 will be excluded. For English speaking patients we will use the English version of the MMSE.
- Has a household member who has already participated (or agreed to participate).
Phase 3:
- Previous participation in Phases 1 or 2 of the study
- Unable/unwilling to use or no access to a telehealth platform (i.e., telephone or videoconference)
- For participants who express interest in RSMI, unable/unwilling to use Zoom videoconferencing platform
- Unable or unwilling to commit to up to 16 weeks to complete 6-session intervention and follow-up assessments
- Major psychiatric illness or cognitive impairment that in the judgment of study investigators or study staff would preclude study participation
- Patients diagnosed with primary brain tumors (per self-report or on the MSKCC EMR), as they may have difficulty completing the intervention and answering questionnaires
- Undergoing hematopoietic stem cell transplantation (HSCT) (per self-report or on the MSKCC EMR)
- Currently in psychotherapeutic treatment (patients being treated with psychotropic medications will not be excluded, as long as they are not in psychotherapy; per self report)
Phase 4:
- Previous participation in Phases 1, 2, or 3 of the study
- Unable/unwilling to use or no access to the Zoom videoconferencing platform (required for RSMI)
- Unable or unwilling to commit to up to 16 weeks to complete 6-session intervention and follow-up assessments
- Major psychiatric illness or cognitive impairment that in the judgment of study investigators or study staff would preclude study participation
- Patients diagnosed with primary brain tumors (per self-report or on the MSKCC EMR), as they may have difficulty completing the intervention and answering questionnaires
- Undergoing hematopoietic stem cell transplantation (HSCT) (per self-report or on the MSKCC EMR)
- Currently in psychotherapeutic treatment (patients being treated with psychotropic medications will not be excluded, as long as they are not in psychotherapy; per self report)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chinese patients with advanced cancer
IMCP intervention to be culturally & linguistically tailored for Chinese cancer patients.
This study will be carried out in 3 phases: 1) formative research & 2) adaptation.
For this application we will continue the formative research (phase 1) by conducting 20 to 30 indepth interviews with Chinese immigrants with advanced cancer to inform the adaptation of the intervention.
Results of the patient in-depth interviews will inform how to adapt the IMCP process & session themes to reflect the needs of the community.
In the adaptation phase (phase 2) the Breitbart IMCP research team (including Drs.
Breitbart, Lichtenthal, & Applebaum), Drs.
Leng, Gany, & Ms. Huang will discuss a priori adaptations to the intervention.
Potential changes to the process & content will be discussed.
Adaptations will be incorporated in a modified IMCP-Ch treatment manual, therapist checklist/outline & Treatment Integrity Coding Manual.
PHASE 3, 4 Conduct feasibility study of IMCP-Ch for Chinese cancer patients.
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The six sessions will be delivered every or every other week over a span of 6-16 weeks, depending on participant and interventionist availability.
Sessions may also be delivered within 2 weeks to accommodate schedules.
Sessions will take place via MSK-approved videoconferencing platforms (e.g.
Zoom) or by telephone, depending on participant preference.
The IMCP-Ch intervention will be delivered via telehealth in Mandarin Chinese by a bilingual interventionist or in English (for bilingual Chinese and English-speaking patients who prefer English) by an English-speaking therapist or through English-to-Mandarin Remote Simultaneous Medical Interpretation (RSMI), depending on participants' preference.
All Phase 4 sessions will be digitally audio-recorded and saved to Zoom cloud.
Cloud recording will be deleted from Zoom after the files have been uploaded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adapt the Individual Meaning-Centered Psychotherapy (IMCP)
Time Frame: 2 years
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through formative research, including in-depth interviews, to be culturally and linguistically tailored for Chinese immigrant cancer patients (IMCP-Ch), using the Ecological Validity Model (EVM) of Bernal et al. (3) and the Cultural Adaptation Process (CAP) model of Domenech-Rodriquez and Weiling (1).
This addresses existential issues using didactics and experiential exercises and has demonstrated efficacy in reducing existential suffering and improving psychosocial functioning among advanced cancer patients.
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2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Florence Lui, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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