- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07625904
Effects of a Five-Dimensional Intervention Program Based on Inner Strength on Demoralization Syndrome in Elderly Cancer Patients
29. maj 2026 opdateret af: Peking Union Medical College Hospital
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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Beijing, Kina, 100076
- Peking Union Medical College Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Inner strength; Elderly; Cancer; Demoralization syndrome
psychological support
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Chinese version of the Disappointment Scale
Tidsramme: one month
|
one month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
self-rating anxiety scale
Tidsramme: one month
|
one month
|
|
Depression Self-Rating Scale
Tidsramme: one month
|
one month
|
|
Chinese Version of the Inner Strength Scale
Tidsramme: one month
|
one month
|
|
Self-Efficacy Scale
Tidsramme: one month
|
one month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. juli 2025
Primær færdiggørelse (Faktiske)
12. december 2025
Studieafslutning (Faktiske)
12. december 2025
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
29. maj 2026
Først opslået (Faktiske)
4. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- K7564
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med psychological support
-
Hospital Costa del SolIkke rekrutterer endnu
-
SIMmersion, LLCTowson UniversityUkendtKønsbekræftende kommunikationsevnerForenede Stater
-
University of California, San FranciscoUnited States Department of Defense; San Francisco Veterans Affairs Medical...AfsluttetAlkoholbrugsforstyrrelse | Post traumatisk stress syndromForenede Stater
-
Pakistan Institute of Living and LearningAktiv, ikke rekrutterendeAutismespektrumforstyrrelse | SelvskadePakistan
-
Yangzhou UniversityAfsluttetIrritabelt tarmsyndrom | Psykologisk intervention | StigmaKina
-
Ye ZhiyinAktiv, ikke rekrutterende
-
Duke UniversityAfsluttet
-
Johns Hopkins UniversityPatient-Centered Outcomes Research InstituteAfsluttet
-
Universitat Autonoma de BarcelonaAfsluttet
-
University of California, Los AngelesAll India Institute of Medical Sciences, New Delhi; University of California... og andre samarbejdspartnereAfsluttet