UMIN-ICDS Clinical Trial

Public title

Understanding how safe and sustainable oral anticancer therapy management is supported: a realist review

Acronym

Patient, family and healthcare-system interactions in oral anticancer therapy: a realist review to refine a programme theory of safe and sustainable treatment management

Scientific Title

Understanding how safe and sustainable oral anticancer therapy management is supported: a realist review

Scientific Title:Acronym

OAT Management Realist Review

Region

Japan

Condition

Management of oral anticancer therapy in people with cancer, without restriction to a single malignancy, stage, treatment intention or regimen.

Classification by specialty

Hematology and clinical oncology

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To develop and refine an explanatory programme theory of how patients, families and healthcare services accomplish different aspects of oral anticancer therapy management under varying contexts and supportive resources, through iterative comparison and testing of supporting, contrasting and rival evidence.

Basic objectives2

Others

Basic objectives -Others

To distinguish medication-taking from treatment safety and to clarify the evidential boundaries between everyday enactment, concerns becoming available to clinicians, professional appraisal and enacted responses, thereby informing oncology nursing, service design and future empirical testing.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

A refined, evidence-bounded programme theory explaining context-dependent relationships among resources, actions or responses and outcomes in oral

Key secondary outcomes

(1) Supported, challenged and bounded explanatory propositions; (2) distinctions between medication enactment and safety; (3) evidential discontinuities between patient-held experience, clinical appraisal and response; and (4) testable implications for nursing and service design.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Literature addressing treatment management, self-management, medication-taking practices, symptom and adverse-effect management, help-seeking, or healthcare and system-level support among patients receiving oral anticancer therapy (OAT) will be considered.

Eligible evidence may include qualitative, quantitative, mixed-methods, interventional and observational studies, as well as relevant literature contributing to the development, testing or refinement of the programme theory.

Evidence will be selected according to its relevance to the review question and programme theory, with consideration of the richness of explanatory information. Methodological rigour will be appraised to inform the interpretation and weighting of evidence.

Key exclusion criteria

Literature without sufficient relevance to OAT management or the review question, and which does not contribute to the development, testing or refinement of the programme theory, will be excluded.

Evidence providing insufficient information about relevant contexts, supportive resources, patient or professional responses, care processes, or outcomes to inform realist interpretation will be excluded following consideration of its potential theoretical contribution.

Target sample size

Name of lead principal investigator

1st name	Hiroko
Middle name
Last name	Komatsu

Organization

Kindai University

Division name

Faculty of Nursing

Zip code

590-0197

Address

1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka

TEL

+81-72-288-7222

Email

hiroko.koma@med.kindai.ac.jp

Name of contact person

1st name	Hiroko
Middle name
Last name	Komatsu

Organization

Kindai University

Division name

Faculty of Nursing

Zip code

590-0197

Address

1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka

TEL

+81-72-288-7222

Homepage URL

Email

hiroko.koma@med.kindai.ac.jp

Institute

Kindai University

Institute

Department

Personal name

Komatsu Hiroko

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Not applicable

Address

Not applicable

Tel

Not applicable

Email

hiroko.koma@med kindai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2026

Year

07

Month

17

Day

Date of IRB

2026

Year

07

Month

17

Day

Anticipated trial start date

2026

Year

10

Month

29

Day

Last follow-up date

2026

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a realist review of existing published literature and does not involve participant recruitment or the collection of new individual-level data. Literature searching and study selection have been completed, while programme theory refinement and manuscript preparation are ongoing. This registration is retrospective.

As the review is based exclusively on published literature, no research ethics committee approval was obtained. The date of 17 July 2026 was entered in the mandatory IRB approval date field in accordance with guidance provided by the UMIN Centre, using the date of the initial protocol. This administrative entry does not represent actual ethics committee approval.

The initial review objectives and literature search strategy were established on 17 July 2026, when exploratory searching commenced under the initial review protocol (Version 1). By mid-August 2026, the methodological direction of the realist review had been clarified through the identification and preliminary analysis of key studies.

Subsequently, iterative examination of the evidence and the development, testing and refinement of programme theories informed revisions to the review protocol. The revised protocol was finalised on 29 October 2026. Accordingly, this registration is retrospective, as the review had commenced before registration. The date of 17 July 2026 refers to the initial protocol, whereas 29 October 2026 refers to the finalisation of the revised protocol.

Registered date

2026

Year

10

Month

29

Day

Last modified on

2026

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072633