Clinical trial NCT02112188: Meaning-Centered Counseling for Chinese Patients Who Are Being Treated for Advanced Cancer
Official title: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Queens Cancer Center of Queens Hospital
name: Charles B. Wang Community Health Center (CBWCHC)
name: American Cancer Society - Asian Initiatives
name: New York Coalition for Asian American Mental Health (NYCAAMH)
name: New York Hospital Queens
name: Chinese Christian Herald Crusades (CCHC)
name: Cheung and Kan Medical Group, PLLC
name: The City College of New York
name: MediSys Health Network
First posted: 2014-04-11
Enrollment: 93
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 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).

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.

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.

Eligibility 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:

* 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

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)

Primary outcomes:
measure: adapt the Individual Meaning-Centered Psychotherapy (IMCP)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: City College of New York (Data Collection AND Data Analysis)
state: New York
city: New York
country: United States
facility: MSK at Ralph Lauren (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Florence Lui, PhD
role: PRINCIPAL_INVESTIGATOR
References: