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Advanced CancerNCT02112188

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

An observational study of Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Advanced Cancer
What is being tested?
In-depth Patient Interviews, Adaptation of IMCP for Chinese Immigrant Cancer Patients and Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3 and Phase 4)
How many people
84 participants
Where
9 sitesUnited States
Study dates
Apr 2014to 15 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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
Show all 21Show fewer
  • 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 or New Jersey
  • 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 or New Jersey

Who cannot join

  • 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)
Show all 20Show fewer
  • 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)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • City College of New York (Data Collection AND Data Analysis)

    New York, New York, 10031

  • MSK at Ralph Lauren (Limited Protocol Activities)

    New York, New York, 10035

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer

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.

Read the 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: Proof-of-concept" single-arm pilot trial of IMCP-Ch 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 examine the effects of using remote interpreting modalities to deliver IMCP-CH to Mandarin-speaking 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) design 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.

Conditions
Advanced Cancer
Being tested
In-depth Patient Interviews, Adaptation of IMCP for Chinese Immigrant Cancer Patients, Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3 and Phase 4)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-depth Patient InterviewsBehavioural

  • Adaptation of IMCP for Chinese Immigrant Cancer PatientsBehavioural

  • Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3 and Phase 4)Behavioural

    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.

Study groups in NCT02112188
Study groupRoleWhat they receive
Chinese patients with advanced cancerIMCP 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.
Receives: 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 and Phase 4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adapt the Individual Meaning-Centered Psychotherapy (IMCP)

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112188
Sponsor's protocol ID
14-076
Status last verified
May 2026
First submitted
7 Apr 2014
Last updated
22 May 2026
Results posted
No

Publications

  • Lui F, Chen RY, Chang F, Jiang R, Yang K, Zhao C, Gany F, Leng J. Lessons from the field: culturally grounded approaches to recruiting Chinese American immigrant cancer patients to psycho-oncology trials. Support Care Cancer. 2026 Jul 4;34(7):733. doi: 10.1007/s00520-026-10932-3.

    PubMed 42400659

  • Lui F, Gany F, Espinosa A, Riobo C, Chang F, Narang B, Rodriguez A, Gonzalez J, Niu Y, Chen RY, Jiang R, Leng J. INTERPRETing to increase access to PSYcho-oncology care (INTERPRET-PSY) for cancer patients with limited English proficiency: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2026 Jan 29;12(1):31. doi: 10.1186/s40814-026-01770-5.

    PubMed 41612461

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adapt the Individual Meaning-Centered Psychotherapy (IMCP) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112188, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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