UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051707
Receipt number R000059011
Scientific Title Online Survey Analysis of Healthcare Providers' Experiences and Responses to Complementary and Alternative Medicine Consultations in Oncology
Date of disclosure of the study information 2023/08/01
Last modified on 2023/07/25 12:29:41

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Basic information

Public title

Healthcare Experience and Response to Oncological Complementary and Alternative Medicine

Acronym

HERO-CAM study

Scientific Title

Online Survey Analysis of Healthcare Providers' Experiences and Responses to Complementary and Alternative Medicine Consultations in Oncology

Scientific Title:Acronym

HERO-CAM study

Region

Japan


Condition

Condition

Healthcare professionals who deal with cancer.

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Geriatrics Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Obstetrics and Gynecology
Pediatrics Ophthalmology Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Radiology Oral surgery
Neurosurgery Plastic surgery Rehabilitation medicine
Nursing Adult Child

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to collect information about the consultations received by healthcare professionals from cancer patients regarding complementary and alternative therapies and to clarify the current situation by examining how these professionals respond to such inquiries.

Basic objectives2

Others

Basic objectives -Others

This study will investigate the following research questions:


1. What types of consultations regarding complementary and alternative therapies are healthcare professionals receiving from cancer patients?
2. How are healthcare professionals responding to these consultations?
3. What knowledge do healthcare professionals have about complementary and alternative therapies, and how are they handling them?

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The proportion of healthcare professionals who have received consultations about complementary and alternative therapies from cancer patients.

Key secondary outcomes

1. The content and proportion of consultations received regarding complementary and alternative therapies, folk remedies, health foods, and supplements.
2. The correlation between the responses after the consultation and the participants' background factors (age, gender, professional classification, years of experience, and education).
3. The correlation between how the participants felt when they received the consultation and their background factors (age, gender, professional classification, years of experience, and education).
4. The correlation between the subsequent treatment policy and the participants' background factors (age, gender, professional classification, years of experience, and education).
5. The correlation between the participants' views on complementary and alternative therapies or folk remedies and their background factors (age, gender, professional classification, years of experience, and education).


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Being a healthcare professional.
2) Directly or indirectly involved with cancer patients.

Key exclusion criteria

1) Multiple survey entries by the same person (excluded systematically).
2) Not currently working as a healthcare professional.
3) Not involved in cancer care.

Target sample size

2500


Research contact person

Name of lead principal investigator

1st name Michio
Middle name
Last name Nakamura

Organization

Sapporo City General Hospital

Division name

Department of Gastroenterology

Zip code

060-8604

Address

1-1, Kita 11-jo Nishi 13-chome, Chuo-ku, Sapporo, JAPAN

TEL

81-11-726-2211

Email

michio.nakamura@doc.city.sapporo.jp


Public contact

Name of contact person

1st name Michio
Middle name
Last name Nakamura

Organization

Sapporo City General Hospital

Division name

Department of Gastroenterology

Zip code

060-8604

Address

1-1, Kita 11-jo Nishi 13-chome, Chuo-ku, Sapporo, JAPAN

TEL

81-11-726-2211

Homepage URL


Email

michio.nakamura@doc.city.sapporo.jp


Sponsor or person

Institute

Non-Profit Organization: Hokkaido Association of Supportive Care in Cancer Patients (HASCAP)

Institute

Department

Personal name



Funding Source

Organization

Non-Profit Organization: Hokkaido Association of Supportive Care in Cancer Patients (HASCAP)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo City General Hospital Ethics Committee

Address

1-1, Kita 11-jo Nishi 13-chome, Chuo-ku, Sapporo, JAPAN

Tel

81-11-726-2211

Email

ho.shomu@city.sapporo.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

NPO法人北海道がんサポーティブケア協会(北海道)


Other administrative information

Date of disclosure of the study information

2023 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2023 Year 07 Month 13 Day

Date of IRB

2023 Year 07 Month 20 Day

Anticipated trial start date

2023 Year 08 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry

2023 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information

Currently preparing for the start of the trial.


Management information

Registered date

2023 Year 07 Month 25 Day

Last modified on

2023 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name