UMIN-ICDS Clinical Trial

Public title

Barriers and Facilitators to Physical Activity Among Adult Women with Breast and Gynecologic Cancer Following Primary Treatment: A Scoping Review Using the COM-B Model

Acronym

Barriers and Facilitators to Physical Activity Among Adult Women with Breast and Gynecologic Cancer Following Primary Treatment: A Scoping Review Using a Behavioral Model

Scientific Title

Barriers and Facilitators to Physical Activity Among Adult Women with Breast and Gynecologic Cancer Following Primary Treatment: A Scoping Review Using the COM-B Model

Scientific Title:Acronym

Barriers and Facilitators to Physical Activity Among Adult Women with Breast and Gynecologic Cancer Following Primary Treatment: A Scoping Review Using the COM-B Model

Region

Japan

Condition

breast and gynecologic cancer (cervical cancer, endometrial cancer, ovarian cancer, etc.)

Classification by specialty

Breast surgery	Obstetrics and Gynecology	Nursing
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This scoping review aims to map existing evidence regarding barriers to and facilitators of physical activity among adult women with breast and gynecologic cancer following primary treatment. Although physical activity is recommended for cancer survivors, maintaining regular activity remains challenging due to various physical, psychological, and social factors. The review will synthesize evidence related to walking and low-intensity resistance training in home and community settings, and categorize identified barriers and facilitators using the COM-B (Capability, Opportunity, Motivation-Behavior) model.

Research question for this review: Established based on the Joanna Briggs Institute (JBI) PCC framework
<Population> Adult women with breast and gynecologic cancer following primary treatment

<Concept> Barriers and facilitators to the maintenance and promotion of walking and low-intensity resistance training

<Context> Home and community settings, with findings mapped onto the COM-B model

Basic objectives2

Others

Basic objectives -Others

Findings from this review will inform the development of future nursing and behavioral interventions to promote physical activity in working-age female cancer survivors.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Barriers and facilitators related to the maintenance and promotion of physical activity, including walking and low-intensity resistance training

Key secondary outcomes

Study type

Observational

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Based on the JBI PCC framework, the following inclusion criteria were established.
<Population>
Adult women survivors with breast cancer or gynecological cancer (e.g., cervical, endometrial, or ovarian cancer) following primary treatment: Patients receiving ongoing endocrine therapy are considered to be post-primary treatment.

<Concept>
Barriers and facilitators related to the maintenance and promotion of walking and low-intensity resistance training (40-60% of 1RM or less, or defined by the authors as low to moderate intensity)

<Context>
Home and community settings: Studies that include facility visits for purposes such as initial instruction will be included, provided that home-based exercise is the primary component of the intervention and factors related to its continuation can be extracted.

Key exclusion criteria

Based on the JBI PCC framework, the following exclusion criteria were established.
<Population>
Participants: Children, adolescents only, men, other cancer types only, receiving palliative care, or in the terminal phase
Proportion of target diseases: Less than 50% of the total participants have the target diseases
Disease stage: Recurrent cancer, metastatic cancer, or Stage IV only

<Concept>
Physical activity and intensity: Exercises other than walking and low-intensity strength training (e.g., yoga, tai chi, swimming, high-intensity strength training)
Duration of physical activity (intervention period): During primary treatment only

<Context>
The primary setting of the exercise is outside the home (e.g., all exercises are conducted in hospitals, facilities, or rehabilitation centers; or exercises are performed 2-3 times a week at a facility with home exercises serving only as a supplement).

Target sample size

0

Name of lead principal investigator

1st name	Minako
Middle name
Last name	Kabasawa

Organization

Niigata College of Nursing

Division name

Faculty of Nursing

Zip code

943-0147

Address

240 Shinnan-cho, Joetsu City, Niigata, Japan

TEL

+81-25-526-2811

Email

minako-k@niigata-cn.ac.jp

Name of contact person

1st name	Minako
Middle name
Last name	Kabasawa

Organization

Niigata College of Nursing

Division name

Faculty of Nursing

Zip code

943-0147

Address

240 Shinnan-cho, Joetsu City, Niigata, Japan

TEL

+81-25-526-2811

Homepage URL

Email

minako-k@niigata-cn.ac.jp

Institute

Niigata College of Nursing

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Takasaki University of Health and Welfare
Gunma University

Name of secondary funder(s)

Organization

Not applicable (Scoping review)

Address

Not applicable (Scoping review)

Tel

-

Email

minako-k@niigata-cn.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

12

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

06

Day

Date of IRB

2026

Year

07

Month

06

Day

Anticipated trial start date

2026

Year

08

Month

10

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

As this study is a scoping review and does not involve human subjects, review and approval by an institutional review board (ethics committee) are not required.

The methods up to data extraction are as follows:

1.Search Strategy
For the literature search, the electronic databases PubMed, MEDLINE and CINAHL (via EBSCOhost), and Ichushi-Web were used. Based on the JBI PCC framework, searches were conducted using keywords such as breast cancer, gynecologic cancer, walking, home-based exercise, low-intensity exercise, barrier, and facilitator. Searching for grey literature and hand searching were not conducted. The search period covered the past 10 years (from January 1, 2016, to July 6, 2026).

2.Screening
The retrieved records will be imported into Rayyan, and duplicates will be removed. Eight reviewers will be organized into four teams of two. All non-duplicated records will be distributed among the four teams, and each reviewer will independently conduct the primary screening by reading the titles and abstracts based on the eligibility criteria. Furthermore, the articles selected in the primary screening will be randomly distributed among the four teams, and each reviewer will independently conduct the secondary screening by reading the full texts based on the eligibility criteria. In the event of any discrepancies between reviewers during the primary or secondary screening, inclusion or exclusion will be determined through discussion within the team. If a consensus cannot be reached, the final decision will be made through discussion with a third reviewer from another team.

3.Data Extraction
From the included studies, data will be extracted. The extracted information will include study characteristics, the content and methods of physical activity, and data representing barriers and facilitators related to the maintenance and promotion of physical activity. Facilitators and barriers will be mapped onto the COM-B model framework.

Registered date

2026

Year

10

Month

11

Day

Last modified on

2026

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072310