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Идёт набор NCT07454330

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

Без фазы С лечением Cancer Survivorship

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cancer Education, Meaning-Centered Counseling, Peer Support, Enhanced Standard Care.
Кому может быть актуально
Состояния в реестре: Cancer, Survivorship. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое Enhanced Standard Care
    enhanced standard care ( written cancer information materials in Chinese and referral to counseling)

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 7 центров
  • 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

Идентификаторы

NCT: NCT07454330 · 26-025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗