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The effect of a multi-professional support program on the burden of symptoms and the activity of the elderly with gastrointestinal cancer

Protocol summary

Study aim
Determining the impact of multi-professional support program on symptom burden and activity of elderly patients with gastrointestinal cancer
Design
The clinical trial work with a control group, with parallel groups, without blinding, randomized with a random number table, sampling will be done in the oncology department of Shahid Rahimi Khorramabad Hospital, and the sample size for each of the groups is 40 people, considering A possible fallout will be considered for each group of 44 people.
Settings and conduct
In the first face-to-face meeting with the patient, questionnaires of individual characteristics, Edmonton symptom burden, and patient activation questionnaire will be completed by the patient. The intervention group during hospitalization and chemotherapy by a team including oncology doctor, nurse, nutritionist, psychologist, social worker. They will receive the necessary interventions during chemotherapy. Each of the above training sessions will be given by the experts of the team for at least half an hour to all the people in the intervention group during two to three days of hospitalization for chemotherapy. The training method is face-to-face. And it will be done on the patient's bed.
Participants/Inclusion and exclusion criteria
Conditions for entry: definitive diagnosis of gastrointestinal cancer, including esophageal cancer, stomach cancer, colon cancer, colorectal cancer, with inclusion in the medical record by a specialist, elderly people over the age of 60, passing at least two sessions of chemotherapy. Conditions for not entering: no disorder Psychological or cognitive disease such as Alzheimer's.. to cooperate in the study
Intervention groups
Intervention group: After getting to know the patient, attendance at the patient's bedside and necessary training and care are performed. Control group: routine care without training.
Main outcome variables
Symptomatic, active

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240723062519N1
Registration date: 2024-08-14, 1403/05/24
Registration timing: prospective

Last update: 2024-08-14, 1403/05/24
Update count: 0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Reza Hosseinabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0140
Email address
reza_hosseinabadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a multi-professional support program on the burden of symptoms and the activity of the elderly with gastrointestinal cancer
Public title
The effect of a multi-professional support program on the burden of symptoms and the activity of the elderly with gastrointestinal cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of gastrointestinal cancer, including esophageal cancer, stomach cancer, colon cancer, colorectal cancer, with inclusion in the medical record by a specialist Elderly and over 60 years old Ability to verbally communicate in Persian or an understandable local dialect Full consent to participate in research work The expected cycle of chemotherapy with an interval of 2 weeks (sometimes based on the opinion of the doctor and the clinical condition of the patient and the type of drug regimen in gastric cancer chemotherapy is three weeks, which is not used in the study) The patient's awareness of having cancer and undergoing chemotherapy Passing at least two sessions of chemotherapy (due to lack of resistance and participation in research activities and the onset of symptoms and side effects of chemotherapy)
Exclusion criteria:
Not suffering from a mental or cognitive disorder such as Alzheimer's.. to cooperate in the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to create a balance in the number of samples assigned to each of the study groups (intervention and control groups), block randomization method is used. For this purpose, random blocks of 4 are used to assign cancer patients to two groups. 6 different combinations of blocks of 4 (AABB- ABAB- ABBA- BBAA- BABA- BAAB) are created and randomly selected using the Blockrand package of R software, and the random sequence is a sequence of letters. A and B will be formed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Lorestan University of Medical Sciences
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Approval date
2024-07-14, 1403/04/24
Ethics committee reference number
IR.LUMS.REC.1403.149

Health conditions studied

1

Description of health condition studied
Gastrointestinal cancer
ICD-10 code
C26.9
ICD-10 code description
Malignant neoplasm of ill-defined sites within the digestive system

2

Description of health condition studied
Multi-professional support program
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Symptom burden
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Elder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Load of symptoms
Timepoint
2 months, a week before, a month after
Method of measurement
The score obtained from the Edmonton Symptom Assessment Scale

2

Description
Activation
Timepoint
2 months, a week before, a month after
Method of measurement
The score obtained from the patient activation measurement questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: In the first face-to-face meeting with the patient, the patient will complete the questionnaires of personal characteristics, Edmonton symptom burden and patient activation questionnaire. If the patient is literate, the questionnaire will be completed by the patient himself, and if the patient is illiterate, the questionnaire will be completed by the patient's companion, and if requested by the patient, the researcher will be present while completing the questionnaire to answer the questions of the patient and his companion. As a routine, patients with gastrointestinal cancer will be hospitalized for chemotherapy for an average of 12 sessions once every two weeks for two to three days. In every session, before the start of chemotherapy, patients go to the department in the morning shift to file and check and send routine tests. And after completing the above mentioned questionnaires, the patients will go home and in the afternoon they will be referred to the department for chemotherapy and will be hospitalized for two to three days. Patients will first be visited by a doctor and chemotherapy orders will be given by the doctor and chemotherapy will be performed by a nurse. In acute cases, a consultation request is given by the doctor and the nurse makes the necessary arrangements for the visit by the consultant and will examine and solve the patient's problem. Also, related to the patient's problem, a pamphlet is provided to the patient. . Therefore, routine interventions will be performed in the control group. In the intervention group, the intervention will be carried out in four sessions for 2 months. These interventions will be carried out by members of the intervention team, including an oncologist, oncology nurse (researcher), nutritionist, psychologist, and social worker. The intervention group in the morning shift who routinely come to file and send tests will be identified by the researcher. And in a private room with the presence of an effective companion (who is in the course of the disease and educated) the training will be given by the researcher. And they will complete the above questionnaires. The intervention group will go on temporary leave (home) and will be admitted to the ward in the evening shift for chemotherapy. In the meantime, the researcher will determine the intervention and control group patients' beds to reduce the communication between these two groups and the intervention group will be in one The room and the control group will be admitted in separate rooms. The intervention group will receive the necessary interventions during chemotherapy by the team including oncology doctor, nurse, nutritionist, psychologist, and social worker during hospitalization and chemotherapy. Each of the above training sessions will be given by the experts of the team for at least half an hour to all the people in the intervention group during two to three days of hospitalization for chemotherapy. The training method will be done face to face and on the patient's bed. Multi-professional intervention: the doctor first visits the patient by a doctor who provides the necessary information about chemotherapy and the necessary guidance to the patient, as well as examining the patient's clinical condition and determining the patient's treatment needs, explaining the treatment costs, the number of sessions, and side effects. Chemotherapy, alternative treatments and how to continue treatment and follow-up after the completion of chemotherapy and if needed, the prognosis of the disease is given, and according to the patient's condition, chemotherapy drugs are prescribed for him. Oncology nurse: coordinating the team and following up on the necessary consultations, monitoring the vital signs, clinical symptoms of the patient and side effects of chemotherapy drugs and, if necessary, following up on the consultations requested for the patient from specialists who are not part of the research team (for example, clinical pharmacologists). . Follow-up of the accurate execution of medical orders by oncology nurses of the department, counseling and guidance of the patient and family, and self-care training for the patient and family members involved in the patient's treatment, and telephone follow-up of the patient's condition and problems after chemotherapy at home, and providing solutions through consultation with the team Research and other experts. Nutritionist: Examining the nutritional needs of the patient and determining the patient's BMI and examining the patient in terms of cachexia and how to manage anorexia and nausea and vomiting caused by the side effects of chemotherapy and the nature of the disease and providing a suitable nutritional plan for the patient before and during chemotherapy and follow-up and assessment of the patient's nutritional status and provide remote counseling to the patient through the team nurse. Psychologist: improving the patient's mood, providing counseling after screening or evaluation in terms of depression and anxiety, and following up and evaluating the patient during chemotherapy. Examining the mental health of the patient and the patient's main caregiver, helping the patient and family match to cope with the problem and follow up treatment, helping the patient to fulfill personal and family roles, and referring to a psychiatrist if needed and providing remote counseling to the patient. through the team nurse. Social worker: examining the support, social and economic problems of the patient and family, introducing the patient to the hospital's support unit in order to obtain financial aid, introducing the patient to the support association for cancer patients, introducing the patient to charity associations, helping to prepare chemotherapy drugs through Charitable associations, facilitating the patient's insurance matters, communicating with the Deputy Food and Drug Administration to facilitate the receipt of drugs and reduce their costs. After the completion of chemotherapy and the patient's discharge, the researcher will contact the patient after one week of the in-person meeting for chemotherapy. took and talked and if there are any complications and problems, they will be trained and guided if possible. And in case of need and more specialized problem, guidance will be obtained from the target team and the patient will be trained. The desired time for telephone follow-up will be approximately 15 minutes and will be proportional to the patient's problems and the patient's ability.The number of non-attendance sessions during the rest period between receiving two chemotherapy sessions, i.e. after one week of receiving chemotherapy, is 4 sessions. In the second round of chemotherapy, the patient is visited again by the team members. The focus of this visit will be more on the examination of chemotherapy experiences and side effects of the procedures performed by the patient and the necessary guidance. In the next visits, the target team will proceed based on the patient's needs and problems, and the training will be based on the patient's needs. In this way, due to the onset of digestive problems caused by chemotherapy, the nutrition expert will provide the necessary guidance to the patient and his family by examining the nutritional status and nutritional problems. The state of mental health and the problems of adapting to the disease are also re-evaluated by the psychologist and take the necessary measures and refer to the specialist if needed. The social worker will also review the process of following up the treatment from the financial and insurance point of view and the cooperation of trustee and charity organizations and will follow up the patient's problems. The doctor will also prescribe the dose of chemotherapy drugs and training based on the patient's needs and according to the patient's problems. will change as necessary. Based on the clinical condition of the patient and the patient's problems, the nurse also provides the necessary training and coordination for the visit by the expert. The next rounds of chemotherapy will be done in the same way, that is, more based on the patient's needs. In each face-to-face session, the information and problems related to the patient are listed by each expert, and in the next sessions, more attention will be paid to solving that problem, and more training and interventions are aimed at solving the patient's problems. Two weeks after the completion of the fourth round of chemotherapy, the questionnaires will be filled again by the patients. In total, we will have four face-to-face visits and four telephone follow-ups within two months.
Category
Lifestyle

2

Description
Control group: During the research period, the control group received their usual care from the oncology department of the hospital and no intervention will be done for them by the research team.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Reza Hossein Abadi
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistant of Lorestan University of Medical Sciences
Full name of responsible person
Bahram Kamrei
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistant of Lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Reza Hossein Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Reza Hossein Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Reza Hossein Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km from Khorram Abad and Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The final thesis report and questionnaires are shared.
When the data will become available and for how long
After registering the thesis and publishing the articles related to the project
To whom data/document is available
The research team, the university research officials, supervisors, editors of specialized journals, researchers in the field of medical sciences.
Under which criteria data/document could be used
Conducting research to improve the quality of life of gastrointestinal cancer patients and their families
From where data/document is obtainable
Responsible researcher
What processes are involved for a request to access data/document
Coordinating with the researcher via e-mail, referring to the library of the Nursing Faculty of Lorestan University of Medical Sciences
Comments
Special cases are not considered.
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