NCT07625904

Brief Summary

From January 2025 to January 2026, a total of 66 elderly cancer patients with demoralization syndrome who were hospitalized in the Department of Internal Medicine at Peking Union Medical College Hospital were enrolled. Participants were allocated randomly to either a control group (CG, n = 33) or an intervention group (IG, n = 33) utilizing a random number table in combination with the ward-floor allocation method. The CG received routine oncology nursing care, whereas the IG received a one-month, five-dimensional intervention program based on inner strength in addition to standard care. Outcomes were assessed utilizing the Chinese versions of Demoralization Scale, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Inner Strength Scale, and Self-Efficacy Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

May 7, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chinese version of the Disappointment Scale

    one month

Secondary Outcomes (4)

  • self-rating anxiety scale

    one month

  • Depression Self-Rating Scale

    one month

  • Chinese Version of the Inner Strength Scale

    one month

  • Self-Efficacy Scale

    one month

Study Arms (1)

Inner strength; Elderly; Cancer; Demoralization syndrome

OTHER

psychological support

Other: psychological support

Interventions

From January 2025 to January 2026, a total of 66 elderly cancer patients with demoralization syndrome who were hospitalized in the Department of Internal Medicine at our hospital were enrolled. Participants were allocated randomly to either a control group (CG, n = 33) or an intervention group (IG, n = 33) utilizing a random number table in combination with the ward-floor allocation method. The CG received routine oncology nursing care, whereas the IG received a one-month, five-dimensional intervention program based on inner strength in addition to standard care. Outcomes were assessed utilizing the Chinese versions of Demoralization Scale, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Inner Strength Scale, and Self-Efficacy Scale.

Inner strength; Elderly; Cancer; Demoralization syndrome

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Diagnosis of a malignant tumor confirmed by pathological biopsy or imaging, in accordance with the Diagnosis and Treatment Specifications for Malignant Tumors
  • Fulfillment of the diagnostic criteria for demoralization syndrome, described as a score \> 30 on the Chinese version of the Demoralization Scale (DS)
  • Clear consciousness, with the capability to communicate effectively or complete questionnaires, and no evidence of cognitive impairment
  • Voluntary participation with signed informed consent
  • Expected survival ≥ 3 months, without vital organs' severe dysfunction, including the liver, kidneys, or heart

You may not qualify if:

  • Presence of psychiatric disorders, severe cognitive impairment, aphasia, or other conditions that would interfere with participation in the intervention or assessments
  • Severe complications, cachexia, or rapidly progressing disease
  • Receipt of psychological interventions or psychotropic medications within the previous month
  • Transfer to another hospital, withdrawal from the study, or loss to follow-up during the study period
  • A history of alcohol or drug dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100076, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

June 4, 2026

Study Start

July 4, 2025

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

June 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations