The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer

Sponsor
Shijiazhuang People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05683236
Collaborator
(none)
84
1
2
35.3
2.4

Study Details

Study Description

Brief Summary

This study proposed a multidisciplinary collaborative team combined with a palliative care model and proposed to establish a team composed of medical staff in various disciplines to make up for the defects of a conventional nursing team. This study applied the multidisciplinary collaboration team combined with a palliative care model to patients with terminal cancer to evaluate its clinical effect.

Condition or Disease Intervention/Treatment Phase
  • Other: Health education
  • Other: Comfort care
  • Other: Pain care
  • Other: Dietary care
  • Other: Psychological and social support care
  • Other: routine nursing intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Clinical Effect Evaluation of Multidisciplinary Collaborative Team Combined With Palliative Care Model in Patients With Terminal Cancer: A Randomised Controlled Study
Actual Study Start Date :
Jun 6, 2019
Actual Primary Completion Date :
May 10, 2022
Actual Study Completion Date :
May 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

The patients in the intervention group received multidisciplinary collaborative team care combined with palliative care.

Other: Health education
Doctors carried out health education for patients to avoid patients giving up their lives, encouraged them to actively cooperate with medical staff, and instructed patients on how to face the disease with a brave and strong attitude and actively fight the disease. Nurses conducted daily psychological counselling for patients, learnt their inner thoughts through communication with patients, and provided timely comfort and encouragement. An attention-shifting method can be used to alleviate the patient's attention to the disease, effectively improving internal depression and avoiding depression. For patients with anxiety and loneliness, family members were instructed to accompany and care.

Other: Comfort care
Reasonable control of indoor temperature and humidity is necessary to ensure that warm, light conditions permit properly dressed patients to feel warm. Nurses need to ensure that patients are kept clean and tidy in personal hygiene. They would regularly assist patients in turning over while giving patients sufficient respect.

Other: Pain care
Clinicians should regularly evaluate the patient's physical pain and give reasonable analgesic drugs to patients. Nurses should closely observe the medication response of patients. At the same time, it is necessary to observe and record patients' physical pain daily and take effective pain control measures.

Other: Dietary care
The clinical nutritionist formulated appropriate nutritional diets according to the nutritional status and personal preferences of patients, provided nutritional support for patients, and followed up with patients once a week after discharge to improve their nutritional status.

Other: Psychological and social support care
Two nurses with psychological counselling qualifications in the team used the anxiety and depression scale to evaluate the psychological and emotional status of patients and referred to "The Questionnaire Survey on Awareness of Palliative Care" by the Department of Elderly Section of the union medical college hospital. The content mainly included the patient's medical history and general situation, the needs and awareness of patients and their families for palliative care, the choice of patients and their families for the final treatment plan, and the needs of families for grief counselling. Timely professional counselling and intervention were undertaken to alleviate the patient's adverse emotions.

Active Comparator: control group

The control group was given routine nursing intervention.

Other: routine nursing intervention
The control group was given routine nursing intervention, strictly in accordance with a routine treatment process, monitoring the vital signs of patients, giving basic nursing, health education, diet guidance and so on.

Outcome Measures

Primary Outcome Measures

  1. Self-rating Anxiety Scale [Within 8 hours after hospitalization]

    This involved 20 items, of which the 5th, 9th, 13th, 17th and 19th items were reverse scoring, and the 1-5 items were positive scoring. The items were scored according to Likert4 grade. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more severe the anxiety state. A score <50 showed no anxiety, 50-59 showed mild anxiety, 60-69 showed moderate anxiety, and >70 showed severe anxiety

  2. Self-rating Anxiety Scale [through study completion, an average of 1 year]

    This involved 20 items, of which the 5th, 9th, 13th, 17th and 19th items were reverse scoring, and the 1-5 items were positive scoring. The items were scored according to Likert4 grade. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more severe the anxiety state. A score <50 showed no anxiety, 50-59 showed mild anxiety, 60-69 showed moderate anxiety, and >70 showed severe anxiety

  3. Self-rating Depression Scale [Within 8 hours after hospitalization]

    There are a total of 20 entries, of which 10 are scored by forward and 10 by reverse. The entries are scored by Likert4 level. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more serious the depression. A score ≤50 showed no depression, 50-59 showed mild depression, 60-69 showed moderate depression, and >70 showed severe depression

  4. Self-rating Depression Scale [through study completion, an average of 1 year]

    There are a total of 20 entries, of which 10 are scored by forward and 10 by reverse. The entries are scored by Likert4 level. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more serious the depression. A score ≤50 showed no depression, 50-59 showed mild depression, 60-69 showed moderate depression, and >70 showed severe depression

  5. Social Support Rating Scale [Within 8 hours after hospitalization]

    The scale was with a total of 10 items, including three dimensions of subjective support, objective support and utilisation of support. The total score of the scale is the sum of the scores of the three dimensions, and the higher the score, the greater the social support. Judgement criteria: A total score of ≤22 indicates a low level, 23-44 indicates a moderate level, and 45-66 indicates a high level, with a domestic norm score of 34.56±3.73

  6. Social Support Rating Scale [through study completion, an average of 1 year]

    The scale was with a total of 10 items, including three dimensions of subjective support, objective support and utilisation of support. The total score of the scale is the sum of the scores of the three dimensions, and the higher the score, the greater the social support. Judgement criteria: A total score of ≤22 indicates a low level, 23-44 indicates a moderate level, and 45-66 indicates a high level, with a domestic norm score of 34.56±3.73

  7. Quality of Life Scale [Within 8 hours after hospitalization]

    QLQ-C30 consists of one overall QOL scale and five functional scales. The functional scales include physical function, role function, emotional function, cognitive function and social function. Rating criteria: After the scores of each part of the scale are converted to standardised scores, and the score range is 0-100. The higher the score on the scale, the better the overall QOL and functional status

  8. Quality of Life Scale [through study completion, an average of 1 year]

    QLQ-C30 consists of one overall QOL scale and five functional scales. The functional scales include physical function, role function, emotional function, cognitive function and social function. Rating criteria: After the scores of each part of the scale are converted to standardised scores, and the score range is 0-100. The higher the score on the scale, the better the overall QOL and functional status

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients were diagnosed as terminal by imaging, pathology and clinical manifestations

  • the expected length of stay was more than seven days

  • patients with clear consciousness, good communication and understanding ability

  • voluntary participation in this study and signing of informed consent

  • the estimated survival period is more than three months

Exclusion Criteria:
  • Patients with cognitive impairment and mental illness

  • those who were seriously ill and could not cooperate with the completion

  • patients with severe communication disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shijiazhuang People's Hospital Shijiazhuang China

Sponsors and Collaborators

  • Shijiazhuang People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yujing Liu, head nurse, Shijiazhuang People's Hospital
ClinicalTrials.gov Identifier:
NCT05683236
Other Study ID Numbers:
  • ShijiazhuangPeoplesH
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 13, 2023