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Meaning-Centered Counseling for Chinese Patients Who Are Being Treated for Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112188
Recruitment Status : Recruiting
First Posted : April 11, 2014
Last Update Posted : June 9, 2022
Sponsor:
Collaborators:
Queens Cancer Center of Queens Hospital
Charles B. Wang Community Health Center (CBWCHC)
American Cancer Society - Asian Initiatives
New York Coalition for Asian American Mental Health (NYCAAMH)
New York Hospital Queens
Chinese Christian Herald Crusades (CCHC)
Cheung and Kan Medical Group, PLLC
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of the study is to modify a type of counseling called "Individual Meaning Centered Psychotherapy" to meet the needs of Chinese cancer patients. Many cancer patients use counseling or other resources to help cope with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer.

Condition or disease Intervention/treatment
Advanced Cancer Behavioral: In-depth Patient Interviews Behavioral: Adaptation of IMCP for Chinese Immigrant Cancer Patients Behavioral: Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3)

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer
Actual Study Start Date : April 2014
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2024

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: Conduct feasibility study of IMCP-Ch for Chinese cancer patients
Behavioral: In-depth Patient Interviews
Behavioral: Adaptation of IMCP for Chinese Immigrant Cancer Patients
Behavioral: Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3)
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.




Primary Outcome Measures :
  1. adapt the Individual Meaning-Centered Psychotherapy (IMCP) [ Time Frame: 2 years ]
    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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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 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).

Criteria

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:

  • Advanced cancer (per physician assessment or on the MSKCC EMR)
  • 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

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)

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): NCT02112188


Contacts
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Contact: Jennifer Leng, MD, MPH 646-888-8057
Contact: Francesca Gany, MD, MS 646-888-8054

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jennifer Leng, MD,MPH    646-888-8057      
Contact: Francesca Gany, MD,MS    646-888-8054      
Principal Investigator: Jennifer Leng, MD, MPH         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Queens Cancer Center of Queens Hospital
Charles B. Wang Community Health Center (CBWCHC)
American Cancer Society - Asian Initiatives
New York Coalition for Asian American Mental Health (NYCAAMH)
New York Hospital Queens
Chinese Christian Herald Crusades (CCHC)
Cheung and Kan Medical Group, PLLC
Investigators
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Principal Investigator: Jennifer Leng, MD, MPH Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02112188    
Other Study ID Numbers: 14-076
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Neoplasms