Comparing the effect of adaptation nurturance using the Adaptive Potential Assessment Model (APAM) and routine education praogram on the self-efficacy and quality of life of patients with colorectal cancer undergoing chemotherapy
Determining The effect of adaptation nurturance by using the Adaptive Potential Assessment Model (APAM) on the self-efficacy and quality of life of patients with colorectal cancer undergoing chemotherapy
Design
a randomized clinical trial with a control group in parallel groups in the third phase without blinding, which will be conducted in the chemotherapeutic department. Seventy patients will be randomly allocated into two groups using Excel software.
Settings and conduct
Colorectal cancer patients hospitalized in the chemotherapy departments of Omid and Ghaem hospitals in Mashhad in two intervention and control groups without blinding in two phases in person and by telephone during two phases of chemotherapy
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 30 to 80 years old; Colorectal cancer diagnosis based on biopsy results and confirmation by a specialist; have a caregiver at home; not diagnosed with mental disorder; familiarity with the Persian language; Having the ability to speak; Equipped with a smartphone.
Exclution criteria: Stage IV of cancer; Evidence of metastasis in the description of the patient's operation
Intervention groups
The intervention group will have at least 3 sessions of 30 to 45 minutes in person during hospitalization and then telephone counseling in a week until two months after the start of the intervention. The intervention includes fostering adaptability based on the patient's potential adaptability review model, which will be done based on Erikson's role modeling and modeling theory. The control group receives hospital training program.
Main outcome variables
self efficacy, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150607022592N3
Registration date:2023-11-06, 1402/08/15
Registration timing:prospective
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
nahid aghebati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
aghebatin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-08, 1402/08/17
Expected recruitment end date
2024-06-06, 1403/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of adaptation nurturance using the Adaptive Potential Assessment Model (APAM) and routine education praogram on the self-efficacy and quality of life of patients with colorectal cancer undergoing chemotherapy
Public title
The effect of adaptation nurturance on the self-efficacy and quality of life of patients with colorectal cancer undergoing chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 30-80 years old
Having Colorectal cancer with an oncologist special diagnosis
Having a caregiver at home
Being Persian
Having the ability to speak
Having a personal smart phone
Exclusion criteria:
Reducing level of consciousness and being refereed to ICU
Evidence of metastasis in the description of the patient's operation
Having a diagnosed psychological disease
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
At first, using statistical software, 18 permutation blocks of size 4 will be recovered. Then the units of each block are placed separately in sealed envelopes. Before starting the sampling, the researcher asks one of the ward nurses to open the first envelope and open the characters inside the envelope for the researcher, according to the patients who met the criteria for entering the study and consent to participate in the study with the help of the consent form. They have consciously announced that they will be placed in the intervention and control groups in parallel. This process will continue until the completion of the samples in two groups based on the sample size of 70 people (35 people in each group).
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 Committees of School of Nursing & Midwifery; Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School; Shahid Dr Kharazmi Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.081
Health conditions studied
1
Description of health condition studied
Colorectal Cancer
ICD-10 code
C18-C21
ICD-10 code description
Malignant neoplasms of digestive organs: Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum, Malignant neoplasm of anus and anal canal
Primary outcomes
1
Description
Self-efficacy score
Timepoint
Before the intervention - the first month and the second month after the start of the study
Method of measurement
Cancer Behavior Inventory–Brief Version (CBI-B)
2
Description
Quality of life score
Timepoint
Before the intervention; 1 month and 2 months later
Method of measurement
Quality of life questionnaire-cancer 30 (EORTC QLQ-C30)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention begins in the second phase of chemotherapy after obtaining informed consent. First, questionnaires to check demographic information, self-efficacy and quality of life are completed by the patient. adaptation Nurturance as an intervention of the present study is implemented in two stages of modeling and role modeling. Nurturance includes educational, supportive and caring interventions. In the modeling stage, the researcher tries to gain the patient's trust and use the process of active listening to determine the patient's adaptation status by using a questionnaire to determine the degree of adaptation based on the nursing theory of modeling and role modeling and determine the existing stressors. Then, a pattern of the patient's adaptation status is drawn, including three phases: arousal, equilibrium, and impoverishment. At this stage, the researcher can determine the patient's condition based on the identification of various internal and external stressors (related stressors of colorectal cancer patients according to existing articles It often includes the disorder of imbalanced nutrition less than body requirements, decreased fluid volume, not knowing how to take care of the colostomy bag, as well as nausea and vomiting and diarrhea caused by chemotherapy.) But based on the unique needs of each patient some other the stressors might be determined. Then, in the role modeling stage, the researcher tries to bring the patient's educational support closer to balance by using appropriate care interventions, if the patient is in the phase of equilibrium or impoverishment. The researcher tries to implement the process of modeling and role modeling for the patient during 3 to 5 face-to-face sessions of 30 to 45 minutes. At least two face-to-face sessions are held in each chemotherapy period. And between the chemotherapy courses, video communication is established with the patient twice using the virtual network, and the patient's condition is evaluated and the necessary recommendations are given to the patient. In the third and fourth stages of chemotherapy (one month and two months after the start of the intervention), the level of self-efficacy and the quality of life of the patient are measured.
Category
Rehabilitation
2
Description
Control group: In the control group, all the usual care and training is done in hospitals, which includes the use of educational pamphlets and participation in health clinic training programs. along with participation in the telephone follow-ups that are done by the nurses of the health clinic of the hospitals. Educational measures and follow-ups by phone and virtual network are done in the intervention group with the coordination of the hospital's health education clinic.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Nioosaha Pahnavar Roudi
Street address
Koohsangi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
niooshaPahnavar1998@gmail.com
2
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Nioosha Pahnavar Roudi
Street address
Ahmad-Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
niooshaPahnavar1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Deputy; The Ghoreishi building; Next to Hoveizeh cinema; Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School; Shahid Dr Kharazmi Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178948564
Phone
+98 51 3800 2000
Email
aghebatin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School; Shahid Dr Kharazmi Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Aghebatin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School; Shahid Dr Kharazmi Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Aghebatin@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available