UMIN-CTR Clinical Trial

Public title

A Multigroup Comparative Study on Changes in Mood States among Cancer Survivors

Acronym

Changes in the mood of cancer survivors

Scientific Title

A Multigroup Comparative Study of Changes in Mood States among Cancer Survivors

Scientific Title:Acronym

Changes in the mood of cancer survivors

Region

Japan

Condition

Cancer survivors within 5 years of diagnosis

Classification by specialty

Not applicable

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to examine changes in mood states among cancer survivors using a multigroup comparative design, focusing on different non-pharmacological approaches such as music, relaxation, and exercise.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in current mood(Profile of Mood States second edition) and fatigue(Cancer Fatigue Scale) before and after intervention.

Key secondary outcomes

Safety and acceptability: Safety and acceptability will be assessed using questionnaires on usability, changes in mood and physical condition during use, and impressions of each intervention.
Medical and sociodemographic characteristics: Medical and sociodemographic characteristics will include sex, economic status, employment status, number and type of cohabitants, educational background (highest level of education), cancer type, time since diagnosis, stage at diagnosis, presence of recurrence or metastasis, current treatment, treatment history, and comorbidities (diseases or injuries other than cancer).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Automatically generated music: Listening to automatically generated music for 15 minutes.
In this study, an intervention using the automatically generated music application soundtope will be implemented. soundtope is a music application developed based on an automated composition system modeled on natural phenomena and is designed to alleviate the tension associated with overly quiet environments. It was also developed to examine the mood-enhancing effects of music. Unlike conventional music, it generates continuously evolving, non-repetitive, organically changing sound in real time. In addition, the application allows users to adjust sound parameters according to their preferences, enabling a personalized intervention. Participants in this study will listen to soundtope for 15 minutes.

Interventions/Control_2

Progressive muscle relaxation: Performing progressive muscle relaxation for 15 minutes.
Progressive muscle relaxation is a method that promotes psychological and physical relaxation by increasing awareness of muscle tension through the sequential contraction and relaxation of muscle groups throughout the body. The intervention will be conducted in a seated position using a chair. As an introduction, diaphragmatic breathing will be performed to regulate breathing, followed by the PMR procedure. Muscle groups including the upper limbs, face/neck/shoulders, trunk, and lower limbs will be sequentially tensed at approximately 60-70% of maximal effort for a short duration and then rapidly relaxed.

Interventions/Control_3

Exercise therapy: Performing exercise therapy for 15 minutes.
The exercise intervention consists of seated exercises. Compared with standing exercises, seated exercises impose less load on the lower limbs and are less effective in improving lower limb muscle strength; however, they can be performed regardless of age and can be adapted to an individual's physical function and condition. In particular, they can be safely performed by individuals who have difficulty maintaining a standing position or who experience severe fatigue. Previous studies have reported that when radio calisthenics were performed among older adults, 75-85% of participants responded "strongly agree" or "agree" to statements such as "my daily rhythm improved," "my mood improved," and "my physical condition improved."

Interventions/Control_4

Control group: Resting for 15 minutes without any intervention.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Diagnosed with cancer within the past 5 years.
(2)Aged 18 years or older.
(3)Able to read and write in Japanese.
(4)Able to understand the study and provide informed consent.

Key exclusion criteria

(1)Judged by the investigator to be unable to participate in the study due to physical or psychological conditions.
(2)Having hearing impairment and routinely using assistive devices such as hearing aids.
(3)Currently receiving treatment for a psychiatric disorder.
(4)Advised by a physician to restrict physical activity.
(5)Judged to have difficulty safely performing light exercise in place due to gait impairment or other physical limitations.

Target sample size

120

Name of lead principal investigator

1st name	Maiko
Middle name
Last name	Fujimori

Organization

Institute for Cancer Control, National Cancer Center

Division name

Division of Supportive Care

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan

TEL

03-3547-5201

Email

mfujimor@ncc.go.jp

Name of contact person

1st name	Maiko
Middle name
Last name	Fujimori

Organization

Institute for Cancer Control, National Cancer Center

Division name

Division of Supportive Care

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan

TEL

03-3547-5201

Homepage URL

Email

mfujimor@ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center IRB

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan

Tel

03-3547-5201

Email

irst@ml.res.ncc.go.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

04

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

02

Day

Date of IRB

2026

Year

04

Month

02

Day

Anticipated trial start date

2026

Year

04

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

Registered date

2026

Year

04

Month

02

Day

Last modified on

2026

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069946