Research policy in supportive care and palliative care for cancer dyspnea

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Abstract

Background

Dyspnea is a common and distressing symptom in patients with cancer. To improve its management, multicenter confirmatory studies are necessary. Research policy would be useful in conducting these studies. Here, we propose a new research policy for the management of dyspnea in patients with cancer.

Methods

The first draft was developed by a policy working group of 11 specialists in the field of supportive care or palliative care for dyspnea. Then, a provisional draft was developed after review by a research support group (the Japanese Supportive, Palliative and Psychosocial Care Study Group) and five Japanese scientific societies (Japanese Association of Supportive Care in Cancer, Japanese Society of Medical Oncology, Japanese Society of Palliative Medicine, Japanese Association of Rehabilitation Medicine and Japanese Society of Clinical Oncology), and receipt of public comments.

Results

The policy includes the following components of research policy on dyspnea: (i) definition of dyspnea, (ii) scale for assessment of dyspnea, (iii) reason for dyspnea or factors associated with dyspnea and (iv) treatment effectiveness outcomes/adverse events. The final policy (Ver1.0) was completed on 1 March 2021.

Conclusions

This policy could help researchers plan and conduct studies on the management of cancer dyspnea.

Abstract

We propose a research policy for the management of dyspnea in patients with cancer. This policy could help researchers plan and conduct studies on the management of cancer dyspnea.

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Most cited references 52

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The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

N. Aaronson, S. Ahmedzai, B Bergman … (1993)

In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.

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EQ-5D: a measure of health status from the EuroQol Group.

F de Charro, R A Rabin (2001)

Established in 1987, the EuroQol Group initially comprised a network of international, multilingual and multidisciplinary researchers from seven centres in Finland, the Netherlands, Norway, Sweden and the UK. Nowadays, the Group comprises researchers from Canada, Denmark, Germany, Greece, Japan, New Zealand, Slovenia, Spain, the USA and Zimbabwe. The process of shared development and local experimentation resulted in EQ-5D, a generic measure of health status that provides a simple descriptive profile and a single index value that can be used in the clinical and economic evaluation of health care and in population health surveys. Currently, EQ-5D is being widely used in different countries by clinical researchers in a variety of clinical areas. EQ-5D is also being used by eight out of the first 10 of the top 50 pharmaceutical companies listed in the annual report of Pharma Business (November/December 1999). Furthermore, EQ-5D is one of the handful of measures recommended for use in cost-effectiveness analyses by the Washington Panel on Cost Effectiveness in Health and Medicine. EQ-5D has now been translated into most major languages with the EuroQol Group closely monitoring the process.

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All references

Author and article information

Contributors

Yoshinobu Matsuda:

ORCID: https://orcid.org/0000-0001-5092-9377

Takashi Yamaguchi

Yoshihisa Matsumoto:

ORCID: https://orcid.org/0000-0003-3112-4818

Hiroto Ishiki

Yuko Usui

Jun Kako

Kozue Suzuki

Ryo Matsunuma:

ORCID: https://orcid.org/0000-0002-7110-3264

Masanori Mori

Hiroaki Watanabe

Sadamoto Zenda:

ORCID: https://orcid.org/0000-0002-0421-5805

Journal

Journal ID (nlm-ta): Jpn J Clin Oncol

Journal ID (iso-abbrev): Jpn J Clin Oncol

Journal ID (publisher-id): jjco

Title: Japanese Journal of Clinical Oncology

Publisher: Oxford University Press

ISSN (Print): 0368-2811

ISSN (Electronic): 1465-3621

Publication date Collection: March 2022

Publication date (Electronic): 11 December 2021

Publication date PMC-release: 11 December 2021

Volume: 52

Issue: 3

Pages: 260-265

Affiliations

Department of Psychosomatic Internal Medicine , National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan

Division of Palliative Care , Department of Medicine, Konan Medical Center, Kobe, Japan

Department of Palliative Medicine , Kobe University Graduate School of Medicine , Kobe, Japan

Department of Palliative Medicine , National Cancer Center Hospital East, Kashiwa, Japan

Department of Palliative Medicine , National Cancer Center Hospital, Tokyo, Japan

Division of Palliative Therapy , Cancer Institute Hospital of Japanese Foundation for Cancer Research , Tokyo, Japan

College of Nursing Art and Science , University of Hyogo , Akashi, Japan

Department of Palliative Care , Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital , Tokyo, Japan

Division of Palliative Care , Department of Medicine, Konan Medical Center, Kobe, Japan

Department of Palliative Medicine , Kobe University Graduate School of Medicine , Kobe, Japan

Palliative and Supportive Care Division , Seirei Mikatahara General Hospital , Hamamatsu, Japan

Home Palliative Care Asunaro Clinic , Komaki, Japan

Department of Radiation Oncology , National Cancer Center Hospital East , Kashiwa, Japan

Author notes

For reprints and all correspondence: Yoshinobu Matsuda, Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan. E-mail: matsuda.yoshinobu.tx@ 123456mail.hosp.go.jp

Author information

Yoshinobu Matsuda https://orcid.org/0000-0001-5092-9377

Yoshihisa Matsumoto https://orcid.org/0000-0003-3112-4818

Ryo Matsunuma https://orcid.org/0000-0002-7110-3264

Sadamoto Zenda https://orcid.org/0000-0002-0421-5805

Article

Publisher ID: hyab193

DOI: 10.1093/jjco/hyab193

PMC ID: 8894919

PubMed ID: 34894136

SO-VID: a7388f2c-49aa-4878-9648-8f70b2e9d687

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

History

Date received : 6 September 2021

Date: 18 November 2021

Date accepted : 22 November 2021

Page count

Pages: 6

Funding

Funded by: Japan Agency for Medical Research and Development, DOI 10.13039/100009619;

Research policy in supportive care and palliative care for cancer dyspnea

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Karger: Oncology

Most cited references 52

ATS statement: guidelines for the six-minute walk test.

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

EQ-5D: a measure of health status from the EuroQol Group.

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