NCT05563207

Brief Summary

To explore the effect of traditional Chinese medicine (TCM) health education standard path on the treatment of patients with acute myeloid leukemia (AML). A total of 60 patients with acute myeloid leukemia in Shijiazhuang Ping An Hospital were selected and divided into control group (n=30) and observation group (n=30) according to the time of admission. Both groups received the same chemotherapy, the control group received routine nursing, and the observation group received TCM health education standard path intervention. The scores of Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Spitzer Quality of Life Index (QLI), awareness of TCM health education standard path content and nursing satisfaction were compared between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 26, 2022

Last Update Submit

September 30, 2022

Conditions

Keywords

acute myeloid leukemiahealth educationtraditional Chinese medicine nursing

Outcome Measures

Primary Outcomes (5)

  • Self-rating anxiety scale

    evaluate the anxiety of the two groups of patients before and after intervention

    3 months of intervention

  • self-rating depression scale

    evaluate depression of the two groups of patients before and after intervention

    3 months of intervention

  • Quality of Life Index

    the Spitzer Quality of Life Index (QLI) was used to evaluate the quality of life of patients

    3 months of intervention

  • Self-made questionnaires to compare the awareness of traditional Chinese medicine health education standard path content

    5 items of propaganda and education content, propaganda and education form, professional level of propaganda and education, nurses' professional attitude, and propaganda and education effect

    3 months of intervention

  • Self-made questionnaires to compare nursing satisfaction

    evaluate the nursing attitude, nursing skills, and explanations of medical staff

    3 months of intervention

Study Arms (2)

control group

EXPERIMENTAL

Both groups of patients were given routine treatment, and were intervened by the same batch of nursing staff. Among them, patients in the control group were given intervention for TCM health education standard path. During chemotherapy, the patient's condition was closely observed, patiently listened to the patient's chief complaint, answered their questions, and instructed the patient to follow the doctor's instructions to prevent complications such as infection and bleeding.

Other: traditional Chinese medicine health education standard path

observation group

ACTIVE COMPARATOR

The patients in the observation group were given TCM health education standard path intervention. The contents of the health intervention mainly included: ① Graphic and text education;②Language education;③ Psychological education; ④Dietary education; ⑤ Complication education

Other: traditional Chinese medicine health education standard pathOther: The contents of the health intervention mainly included:Graphic and text educationOther: The contents of the health intervention mainly included:Language educationOther: The contents of the health intervention mainly included:Psychological educationOther: The contents of the health intervention mainly included:Dietary educationOther: The contents of the health intervention mainly included:Complication education

Interventions

Both groups of patients were given routine treatment, and were intervened by the same batch of nursing staff.During chemotherapy, the patient's condition was closely observed, patiently listened to the patient's chief complaint, answered their questions, and instructed the patient to follow the doctor's instructions to prevent complications such as infection and bleeding.

control groupobservation group

When the patient was admitted to the hospital, the responsible nurse had a comprehensive understanding of the patient's disease cognition and psychological state, and based on this, an individualized intervention plan was formulated. With the help of publicity boards, brochures and other forms of pictures and texts, to popularize the knowledge and precautions of disease treatment for patients

observation group

adopt one-to-one method to inform patients of the principles, effects and precautions of chemotherapy, eliminate patients' misunderstandings, and repeat language education for many times during the treatment process to strengthen patients' memory

observation group

guide patients to express their own emotions, according to the patient's personality, cultural background, etc., after communicating with family members and negotiating, selectively inform the patient's actual condition

observation group

instruct patients to follow the principles of light, easy to digest and balanced nutrition

observation group

Actively inform patients about complications in advance, and guide their prevention methods, such as increasing water intake, avoiding activities of affected limbs after chemotherapy, etc. Patients with vomiting, hair loss and other adverse reactions are prone to negative emotions such as anxiety and depression , timely take corresponding measures and appease the patient, inform them that it is a normal phenomenon, and guide them to maintain a good attitude.

observation group

Eligibility Criteria

Age37 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to the hospital for the first time during the observation period
  • patients who met the diagnostic criteria for AML
  • patients with stable disease, clear consciousness, fluent speech, and normal communication
  • patients who volunteered to participate in the research

You may not qualify if:

  • patients who were repeatedly admitted to hospital during the investigation period
  • patients with hospitalization time ≤3 days
  • patients whose condition changed after admission and could not continue to cooperate with the investigation
  • patients who asked to withdraw during the observation period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shijiazhuang Pingan Hospital

Shijiazhuang, Hebei, 050021, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteHealth Education

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 3, 2022

Study Start

March 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations