Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Schenectady, New York, Estados Unidos, 12308
- Ellis Medicine/Roswell Park Medical Oncology
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
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.
Exclusion Criteria:
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Survivorship Visit Intervention
Participants will receive a single structured survivorship visit during active cancer treatment.
The visit will be guided by responses to the NCCN Distress Thermometer and Problem List and will address physical, emotional, social, practical, and spiritual concerns identified during distress screening.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
Prazo: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
|
Psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer and Problem List, a validated self-report measure in which participants rate their overall distress on a scale from 0 (no distress) to 10 (extreme distress).
Change in distress scores from baseline to follow-up assessments will be evaluated.
|
Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Quality of Life as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G)
Prazo: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
|
Quality of life will be assessed using the FACT-G, a 27 item validated measure of cancer-related quality of life.
Total scores range from 0 to 108, with higher scores indicating better quality of life.
Change in FACT-G total scores from baseline to follow-up assessments will be evaluated.
|
Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- 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.
- 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.
- Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
- 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.
- 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.
- 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.
- 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.
- 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.
- Carlson LE, Zelinski EL, Toivonen KI, Sundstrom L, Jobin CT, Damaskos P, Zebrack B. Prevalence of psychosocial distress in cancer patients across 55 North American cancer centers. J Psychosoc Oncol. 2019 Jan-Feb;37(1):5-21. doi: 10.1080/07347332.2018.1521490. Epub 2018 Dec 28.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 00008111-04302026-MAH
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .