Ignite Creation Date:
2024-05-06 @ 2:44 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02112188
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2014-04-07
Brief Title:
Meaning-Centered Counseling for Chinese Patients Who Are Being Treated for Advanced Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 checklistoutline 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 controlgold standard in delivering IMCP-Ch
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 controlgold standard in delivering IMCP-Ch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None