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Completed

NCT Number: NCT07625904

Effects of a Five-Dimensional Intervention Program Based on Inner Strength on Demoralization Syndrome in Elderly Cancer Patients

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.

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Key information

Conditions

Demoralization

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, 100076, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Psychological Support

Other

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.

Primary outcomes

  1. Chinese version of the Disappointment Scale

    Time frame: one month

Secondary outcomes

  1. self-rating anxiety scale

    Time frame: one month

  2. Depression Self-Rating Scale

    Time frame: one month

  3. Chinese Version of the Inner Strength Scale

    Time frame: one month

  4. Self-Efficacy Scale

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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