Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology

Обзор

The goal of this study is to understand whether providing a structured survivorship care visit at the beginning of cancer treatment is associated with changes in distress and quality of life in adults with cancer receiving treatment in a community oncology clinic. The main questions it aims to answer are: * Is participation in a structured survivorship visit at the start of active treatment associated with changes in psychological distress? * Is participation in the survivorship visit associated with changes in quality of life? Participants will: * Be asked to complete questionnaires about their level of distress and overall quality of life. * Participate in a single survivorship visit with the clinic's Physician Assistant at the Ellis Medical Oncology Clinic. * Complete the same questionnaires again approximately two weeks and one month after the survivorship visit.

Подробное описание

Psychological distress is common among individuals with cancer, and many patients experience emotional, social, physical, and practical challenges throughout treatment. Despite the high prevalence of distress, psychosocial needs often go unrecognized or inadequately addressed in routine oncology care. Unmet psychosocial needs have been associated with poorer quality of life, increased symptom burden, and difficulties coping with cancer and its treatment.

Survivorship care may represent one approach to addressing these needs. Cancer survivorship care focuses on the ongoing physical, emotional, and psychosocial effects of cancer and is designed to promote overall well-being and quality of life. Traditionally, survivorship care has been delivered after completion of active treatment. However, active treatment is often one of the most physically and emotionally demanding phases of the cancer journey. Providing survivorship care earlier may allow concerns to be identified and addressed as they arise rather than waiting until treatment has ended.

This single-arm pilot study aims to evaluate the feasibility and preliminary impact of a structured survivorship visit for patients experiencing clinically significant distress in a community oncology clinic. Patients with a score of ≥4 on the NCCN Distress Thermometer who express interest in participating will be offered a survivorship visit guided by their Distress Thermometer and Problem List responses. 15 adult patients will participate in this pilot. Changes in psychological distress and quality of life will be assessed using the NCCN Distress Thermometer and the Functional Assessment of Cancer Therapy-General (FACT-G) before and after the survivorship visit to explore whether this brief, structured intervention may be associated with improvements in distress and quality of life. Findings from this study will help inform the development of future studies evaluating the role of early survivorship care in improving psychosocial outcomes and quality of life among patients with cancer.

Вмешательства

• Поведенческое Structured Survivorship Visit
  A structured survivorship care visit conducted by a trained Physician Assistant during the beginning of active cancer treatment. The visit uses patient-reported distress screening results to guide discussion of psychosocial, physical, practical, and supportive care needs. Counseling, education, care coordination, and referrals may be provided as appropriate within routine clinical practice.

Первичные конечные точки

• Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List [Срок оценки: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit]

Вторичные конечные точки (1)

• Change in Quality of Life as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit]

Критерии участия

Критерии включения

Patients must fulfill all the following criteria to be included in the study:

• Age 18 years and older.
• Patients with histologically confirmed malignancy, any stage or type.
• Beginning active therapy (either in oral or IV) for cancer at Ellis Medicine/Roswell Park Medical Oncology.
• A score of ≥4 on the NCCN Distress Thermometer at screening.
• Able and willing to provide written informed consent.
• Ability to read and understand English sufficiently to complete study questionnaires.

Критерии исключения

Patients with one or more of the following criteria will be excluded from the study:

• Under the age of 18 years.
• Patient is unable to provide informed consent.
• Currently receiving ongoing therapy or have had treatment for cancer in the past (i.e., not a new start)
• Significant cognitive impairment that would preclude completion of study questionnaires

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Ellis Medicine/Roswell Park Medical Oncology — Schenectady

Публикации

• Yusufov M, Adeyemi O, Flannery M, Bouillon-Minois JB, Van Allen K, Cuthel AM, Goldfeld KS, Ouchi K, Grudzen CR. Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department. J Palliat Med. 2024 Jan;27(1):63-74. doi: 10.1089/jpm.2022.0270. Epub 2023 Sep 6. PMID 37672598
• Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. PMID 20818875
• Penedo FJ, Natori A, Fleszar-Pavlovic SE, Sookdeo VD, MacIntyre J, Medina H, Moreno PI, Crane TE, Moskowitz C, Calfa CL, Schlumbrecht M. Factors Associated With Unmet Supportive Care Needs and Emergency Department Visits and Hospitalizations in Ambulatory Oncology. JAMA Netw Open. 2023 Jun 1;6(6):e2319352. doi: 10.1001/jamanetworkopen.2023.19352. PMID 37342038
• Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1. PMID 31538028
• Mollica MA, Doose M, Reed C, Tonorezos E. Defining concepts in cancer survivorship. Cancer. 2025 Aug 15;131(16):e70039. doi: 10.1002/cncr.70039. PMID 40810248
• Mehari WD, Sun Y, Lei Y, Shine S, Seyoum E, Getu MA. Unmet supportive care need and associated factors among cancer patients. BMC Cancer. 2025 Aug 2;25(1):1260. doi: 10.1186/s12885-025-14607-w. PMID 40753208
• Hong YR, Yadav S, Suk R, Khanijahani A, Erim D, Turner K. Patient-provider discussion about emotional and social needs, mental health outcomes, and benefit finding among U.S. Adults living with cancer. Cancer Med. 2021 Jun;10(11):3622-3634. doi: 10.1002/cam4.3918. Epub 2021 May 7. PMID 33960716
• Halpern MT, Viswanathan M, Evans TS, Birken SA, Basch E, Mayer DK. Models of Cancer Survivorship Care: Overview and Summary of Current Evidence. J Oncol Pract. 2015 Jan;11(1):e19-27. doi: 10.1200/JOP.2014.001403. Epub 2014 Sep 9. PMID 25205779

Идентификаторы

NCT: NCT07673731 · 00008111-04302026-MAH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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