Multidisciplinary CollaborativeNCT05683236
The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer
A study testing Health education, Comfort care and Pain care in people with Multidisciplinary Collaborative and Palliative Care Model, run by Shijiazhuang People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multidisciplinary Collaborative, Palliative Care Model, Quality of Life
- What is being tested?
- Health education, Comfort care and Pain care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2019to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with cognitive impairment and mental illness
- those who were seriously ill and could not cooperate with the completion
- patients with severe communication disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Health education, Comfort care, Pain care, Dietary care, Psychological and social support care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
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.
Comfort careOther
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.
Pain careOther
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.
Dietary careOther
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.
Psychological and social support careOther
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.
routine nursing interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The patients in the intervention group received multidisciplinary collaborative team care combined with palliative care. Receives: Other: Health education; Other: Comfort care; Other: Pain care; Other: Dietary care; Other: Psychological and social support care |
| control group | Active comparator | The control group was given routine nursing intervention. Receives: Other: routine nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rating Anxiety Scale
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
Measured: Within 8 hours after hospitalization
Self-rating Anxiety Scale
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
Measured: through study completion, an average of 1 year
Self-rating Depression Scale
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
Measured: Within 8 hours after hospitalization
Self-rating Depression Scale
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
Measured: through study completion, an average of 1 year
Social Support Rating Scale
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
Measured: Within 8 hours after hospitalization
Social Support Rating Scale
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
Measured: through study completion, an average of 1 year
Quality of Life Scale
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
Measured: Within 8 hours after hospitalization
Quality of Life Scale
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start6 Jun 2019
- Primary completion10 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multidisciplinary CollaborativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujing Liu, Shijiazhuang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683236
- Sponsor's protocol ID
- ShijiazhuangPeoplesH
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu YJ, Wu LP, Wang H, Han Q, Wang SN, Zhang J. The clinical effect evaluation of multidisciplinary collaborative team combined with palliative care model in patients with terminal cancer: a randomised controlled study. BMC Palliat Care. 2023 Jun 13;22(1):71. doi: 10.1186/s12904-023-01192-7.
PubMed 37312118
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect Evaluation of Multidisciplinary Collaborative Team Combined With Palliative Care Model in Patients With Terminal Cancer: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05683236
- Acronym / sponsor ID
- ShijiazhuangPeoplesH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shijiazhuang People's HospitalUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Health education, Other: Comfort care, Other: Pain care, Other: Dietary care, Other: Psychological and social support careThe patients in the intervention group received multidisciplinary collaborative team care combined with palliative care. |
| control group | Active comparator | Other: routine nursing interventionThe control group was given routine nursing intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with cognitive impairment and mental illness
- those who were seriously ill and could not cooperate with the completion
- patients with severe communication disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationDoctors 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 | intervention group |
| Comfort careReasonable 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 | intervention group |
| Pain careClinicians 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 | intervention group |
| Dietary careThe 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 | intervention group |
| Psychological and social support careTwo 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. | Other | intervention group |
| routine nursing interventionThe 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. | Other | control group |
Primary outcome
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 37312118Liu YJ, Wu LP, Wang H, Han Q, Wang SN, Zhang J. The clinical effect evaluation of multidisciplinary collaborative team combined with palliative care model in patients with terminal cancer: a randomised controlled study. BMC Palliat Care. 2023 Jun 13;22(1):71. doi: 10.1186/s12904-023-01192-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education, Comfort care and Pain care in people with Multidisciplinary Collaborative and Palliative Care Model, run by Shijiazhuang People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rating Anxiety Scale (time frame: Within 8 hours after hospitalization). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.