UMIN-CTR Clinical Trial

Public title

linical Practice Guidelines for the Management and Care of Psychological Distress Experienced by Family Members Who Are Expected to Lose a Loved One in the Near Future and Bereaved Individuals Who Have Lost a Loved One Due to Cancer or Other Physical Illnesses, 202X Edition

Acronym

Family and Bereavement Care Guidelines, 202X Edition

Scientific Title

Is Psychological Support Recommended to Alleviate Psychological Distress in Adult Family Members Aged 18 Years or Older Who Are Expected to Lose a Loved One in the Near Future Due to Cancer or Other Physical Illnesses?

Scientific Title:Acronym

Pre-loss Family Psychological Support CQ

Region

Japan

Condition

Psychological distress, including anticipatory grief, experienced before the patient's death by family members of patients with cancer or other life-threatening physical illnesses

Classification by specialty

Medicine in general	Hematology and clinical oncology	Psychosomatic Internal Medicine
Psychiatry	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this systematic review is to determine whether psychological support provided before the death of the patient to adult family members aged 18 years or older who are expected to lose a loved one in the near future due to cancer or another life threatening physical illness improves family outcomes, including anticipatory grief, psychological distress, anxiety, depression, caregiver burden, quality of life, and preparedness for death. The findings will be used to inform recommendations in a clinical practice guideline for family and bereavement care.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The severity of psychological distress among adult family members or significant others aged 18 years or older who are expected to lose a loved one in the near future due to cancer or another physical illness, assessed while the patient is alive. Psychological distress includes general psychological distress, anticipatory grief, pre loss grief, anxiety, and related emotional distress. Scores after the intervention or changes from baseline measured using validated instruments will be evaluated.

For outcomes assessed before death, the primary time point will be immediately after completion of the intervention or the first assessment after the intervention conducted while the patient is alive. When multiple assessments are available, immediate, short term, and medium to long term outcomes will be evaluated separately.

Key secondary outcomes

The following secondary outcomes will be evaluated.

Quality of life. Scores after the intervention or changes from baseline measured using validated quality of life instruments.

Complicated grief or prolonged grief symptoms. Severity or incidence of grief symptoms assessed after the death of the patient using validated grief measures.

Depression. Severity of depressive symptoms measured using validated instruments, or incidence of depression as defined by each study.

Dropout rate. The proportion of participants allocated to psychological support who do not complete the intervention or study assessments.

Psychological burden associated with the intervention. Worsening of psychological distress, temporary worsening of anxiety or grief, or other psychological adverse events related to psychological support.

Economic burden. Direct or indirect costs incurred by family members, including intervention costs, transportation expenses, communication or equipment costs, and loss of income or work time.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Studies including adult family members or significant others aged 18 years or older of patients with cancer or another physical illness.

2. The family members or significant others are expected to lose the patient in the near future.

3. Psychological support intended to reduce psychological distress among family members or significant others is initiated or provided before the death of the patient.

4. The intervention is compared with usual care, no intervention, a waiting list, or another control intervention.

5. The study reports at least one of the following outcomes: psychological distress, quality of life, complicated grief or prolonged grief, depression, dropout, psychological burden associated with the intervention, or economic burden.

6. Randomized controlled trials or other controlled intervention studies are eligible.

Key exclusion criteria

1. Studies including only family members younger than 18 years.

2. Studies including only patients or healthcare professionals and not evaluating outcomes among adult family members or significant others.

3. Studies limited to unexpected bereavement caused by sudden death, accidents, suicide, disasters, or similar events.

4. Studies in which psychological support is initiated only after the death of the patient and is not provided before death.

5. Studies that do not include psychological support for adult family members or significant others.

6. Studies without an eligible control group.

7. Qualitative studies, case reports, narrative reviews, systematic reviews, study protocols, editorials, letters, and conference abstracts with insufficient data.

8. Studies that do not report usable data for any outcome specified in this review.

Target sample size

Name of lead principal investigator

1st name	Yoichi
Middle name
Last name	Ohtake

Organization

Body Mind Clinic, Takeo Clinic

Division name

Internal Medeicine

Zip code

5620045

Address

4-13-11, Segawa, Minoh-city, Osaka

TEL

070-9121-5878

Email

bodymindclinic.jp@gmail.com

Name of contact person

1st name	Yoichi
Middle name
Last name	Ohtake

Organization

Body Mind Clinic, Takeo Clinic

Division name

Internal Medicine

Zip code

5620045

Address

4-13-11, Segawa, Minoh-city, Osaka

TEL

070-9121-5878

Homepage URL

Email

bodymindclinic.jp@gmail.com

Institute

Japan Psycho-Oncology Society

Institute

Department

Personal name

Organization

Japan Psycho-Oncology Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Body Mind Clinic, Takeo Clinic

Address

4-13-11, Segawa, Minoh-city, Osaka

Tel

070-9121-5878

Email

bodymindclinic.jp@gmail.com

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

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

2134

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

06

Month

01

Day

Date of IRB

2026

Year

06

Month

15

Day

Anticipated trial start date

2026

Year

06

Month

30

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This systematic review will inform a clinical practice guideline for family and bereavement care. It will assess the effectiveness and safety of psychological support provided before the death of the patient to adult family members or significant others aged 18 years or older who are expected to lose a loved one in the near future due to cancer or another physical illness.

Eligible interventions include psychotherapy, counseling, psychoeducation, psychosocial support, communication support, and support delivered online or by mobile applications. Comparators include usual care, no intervention, waiting list, or another control intervention.

The primary outcome is psychological distress, including general distress, anticipatory grief, pre loss grief, and anxiety. Secondary outcomes include quality of life, complicated or prolonged grief, depression, dropout, psychological burden related to the intervention, and economic burden.

A systematic search will be conducted using PubMed and other databases specified in the protocol. The PubMed search was conducted on June 26, 2026. Citation searching and hand searching will also be performed.

Study selection, data extraction, and risk of bias assessment will be conducted independently by multiple reviewers. Randomized controlled trials and other controlled intervention studies will be included. Meta analysis will be performed when studies are sufficiently similar. Otherwise, findings will be summarized narratively. Heterogeneity and certainty of evidence will be assessed.

Registered date

2026

Year

08

Month

02

Day

Last modified on

2026

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071458