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Recruiting NCT07454330

Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors

No phase Interventional Cancer Survivorship

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cancer Education, Meaning-Centered Counseling, Peer Support, Enhanced Standard Care.
Who it may be relevant to
Registry conditions: Cancer, Survivorship. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multicomponent Support Program to Enhance Quality of Life in Chinese Cancer Patients and Survivors (MSP-CCS): Pilot Optimization Trial and Implementation Outcomes

Overview

The purpose of this study is to evaluate different combinations of cancer education sessions, counseling sessions, and peer support meetings developed for Chinese cancer patients and survivors. The researchers will look at whether the combinations are practical and effective, and how they impact participants' quality of life.

Interventions

  • Other Cancer Education
    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.
  • Other Meaning-Centered Counseling
    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.
  • Other Peer Support
    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.
  • Other Enhanced Standard Care
    enhanced standard care ( written cancer information materials in Chinese and referral to counseling)

Primary outcome measures

  • Proportion of eligible participants who enroll in the trial. [Time frame: 2 years]
  • Proportion of participants who complete treatment [Time frame: 24 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT07454330 · 26-025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗