The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer

January 11, 2023 updated by: Yujing Liu, Shijiazhuang People's Hospital

The Clinical Effect Evaluation of Multidisciplinary Collaborative Team Combined With Palliative Care Model in Patients With Terminal Cancer: A Randomised Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shijiazhuang, China
        • Shijiazhuang People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-rating Anxiety Scale
Time Frame: 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
Within 8 hours after hospitalization
Self-rating Anxiety Scale
Time Frame: 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
through study completion, an average of 1 year
Self-rating Depression Scale
Time Frame: 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
Within 8 hours after hospitalization
Self-rating Depression Scale
Time Frame: 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
through study completion, an average of 1 year
Social Support Rating Scale
Time Frame: 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
Within 8 hours after hospitalization
Social Support Rating Scale
Time Frame: 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
through study completion, an average of 1 year
Quality of Life Scale
Time Frame: 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
Within 8 hours after hospitalization
Quality of Life Scale
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shijiazhuang People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShijiazhuangPeoplesH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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