Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
A Multicomponent Support Program to Enhance Quality of Life in Chinese Cancer Patients and Survivors (MSP-CCS): Pilot Optimization Trial and Implementation Outcomes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jennifer Leng, MD, MPH
- Phone Number: 646-888-8057
Study Contact Backup
- Name: Florence Lui, PhD
- Phone Number: 646-888-8375
- Email: luif@mskcc.org
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
East White Plains, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Contact:
- Jennifer Leng, MD, MPH
- Phone Number: 646-888-8057
-
Principal Investigator:
- Florence Lui, PhD
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
Contact:
- Florence Lui, PhD
- Phone Number: 646-888-8375
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with cancer (any type/stage) (per EMR for MSK patients or self-report for external participants) within the last 5 years
- Age ≥ 18 years (per EMR for MSK patients or self-report for external participants)
Self-Report Criteria:
- Of Chinese descent
- Speaks Mandarin "well" or "very well"
- Moderately low HRQOL (<70 FACT-G score)4, 48
- Resides in New York or New Jersey
- Agrees to participate via telehealth (video or phone)
- Agrees to be audio-recorded
Exclusion Criteria:
Self-Report Criteria:
- Per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9,5 they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale. They will be excluded from participation in this study if there is presence of suicidal risk, determined by affirmative response(s) on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
- Cognitive impairment (Montreal Cognitive Assessment 5 Minute - telephone version with a score < 12)
- Per consenting professional determination, unable to understand the informed consent procedure
- Participation in study #14-076: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese immigrant cancer patients)
- Currently receiving/have received psychotherapy/counseling/peer support within the last 6 months (patients being treated solely with psychotropic medications will not be excluded if they are not receiving psychotherapy/counseling/peer support)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
Peer support meetings, will have 3 monthly meetings.
|
Cancer Education on side effects and their management, treatment options, advance care planning, and survivorship.
Each session will last about 30-60 minutes and will be completed over the phone or by video call.
Meaning-centered counseling aims to activate culturally relevant meaning-focused coping strategies in Chinese-speaking patients and survivors (CCS).
Each session will last about 45-60 minutes and will be completed over the phone or by video call.
Peer support aims to increase social support for CCS to decrease cancer stigma, which has been associated with greater psychological distress, especially among less acculturated Chinese immigrant CCS.
The meetings will include up to 6-8 Mandarin-speaking patients and survivors and will last about 90 minutes.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
|
Cancer Education on side effects and their management, treatment options, advance care planning, and survivorship.
Each session will last about 30-60 minutes and will be completed over the phone or by video call.
Meaning-centered counseling aims to activate culturally relevant meaning-focused coping strategies in Chinese-speaking patients and survivors (CCS).
Each session will last about 45-60 minutes and will be completed over the phone or by video call.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Cancer education sessions, will have 3 weekly sessions.
Peer support meetings, will have 3 monthly meetings.
|
Cancer Education on side effects and their management, treatment options, advance care planning, and survivorship.
Each session will last about 30-60 minutes and will be completed over the phone or by video call.
Peer support aims to increase social support for CCS to decrease cancer stigma, which has been associated with greater psychological distress, especially among less acculturated Chinese immigrant CCS.
The meetings will include up to 6-8 Mandarin-speaking patients and survivors and will last about 90 minutes.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 4 - Cancer Education + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Cancer education sessions, will have 3 weekly sessions.
|
Cancer Education on side effects and their management, treatment options, advance care planning, and survivorship.
Each session will last about 30-60 minutes and will be completed over the phone or by video call.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions.
Peer support meetings, will have 3 monthly meetings
|
Meaning-centered counseling aims to activate culturally relevant meaning-focused coping strategies in Chinese-speaking patients and survivors (CCS).
Each session will last about 45-60 minutes and will be completed over the phone or by video call.
Peer support aims to increase social support for CCS to decrease cancer stigma, which has been associated with greater psychological distress, especially among less acculturated Chinese immigrant CCS.
The meetings will include up to 6-8 Mandarin-speaking patients and survivors and will last about 90 minutes.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 6 - Meaning-Centered Counseling- + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Counseling sessions, will have 3 weekly sessions.
|
Meaning-centered counseling aims to activate culturally relevant meaning-focused coping strategies in Chinese-speaking patients and survivors (CCS).
Each session will last about 45-60 minutes and will be completed over the phone or by video call.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Experimental: 7 - Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Peer support meetings, will have 3 monthly meetings
|
Peer support aims to increase social support for CCS to decrease cancer stigma, which has been associated with greater psychological distress, especially among less acculturated Chinese immigrant CCS.
The meetings will include up to 6-8 Mandarin-speaking patients and survivors and will last about 90 minutes.
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
|
Active Comparator: 8 - Enhanced Standard Care
All participants will also receive cancer information materials and resources.
|
enhanced standard care ( written cancer information materials in Chinese and referral to counseling)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of eligible participants who enroll in the trial.
Time Frame: 2 years
|
2 years
|
|
|
Proportion of participants who complete treatment
Time Frame: 24 weeks
|
Pproportion of assessments that are completed, with completion defined as submitting the 24-week assessment with a minimum of the FACT-G completed.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
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)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 26-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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