Comparison of the Effectiveness of Digital Storytelling by Peers and Routine Treatment on Changes in Self-Efficacy and Rumination in Individuals with Colorectal Cancer.
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General information
2024-12-10, 1403/09/20
2025-08-23, 1404/06/01
20242025-1208-1023 00:00:00
2025-12-11, 1404/09/20
2025-12-21, 1404/09/30
2025-12-1121 00:00:00
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The expected start date of participant recruitment was updated to align with the study's planned timeline.
The expected start date of participant recruitment was updated to align with the study's planned timeline.
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به‌روزرسانی تاریخ مورد انتظار شروع نمونه‌گیری به منظور انطباق با برنامه زمان‌بندی پیش‌بینی‌شده مطالعه انجام شد
به‌روزرسانی تاریخ مورد انتظار شروع نمونه‌گیری به منظور انطباق با برنامه زمان‌بندی پیش‌بینی‌شده مطالعه انجام شد
Recruitment centers
#1
Name of recruitment center - English: Cancer Institute of Imam Khomeini Hospital, Tehran
Name of recruitment center - Persian: موسسه سرطان بیمارستان امام خمینی شهر تهران
Full name of responsible person - English: sajjad soofi
Full name of responsible person - Persian: سجاد صوفی
Street address - English: Keshavarz, Boulevard, Dr. Gharib Street
Street address - Persian: انتهای بلوار کشاورز – خیابان دکتر قریب
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6658 1625
Fax:
Email: Imamhospital@tums.ac.ir
Web page address:
Name of recruitment center - English: Cancer Institute of Imam Khomeini Hospital, Tehran
Name of recruitment center - Persian: موسسه سرطان بیمارستان امام خمینی شهر تهران
Full name of responsible person - English: Sajjad Soofi
Full name of responsible person - Persian: سجاد صوفی
Street address - English: Dr. Gharib Street, Keshavarz, Boulevard
Street address - Persian: انتهای بلوار کشاورز – خیابان دکتر قریب
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6658 1625
Fax:
Email: Imamhospital@tums.ac.ir
Web page address:
Name of recruitment center - English: Cancer Institute of Imam Khomeini Hospital, Tehran Name of recruitment center - Persian: موسسه سرطان بیمارستان امام خمینی شهر تهران Full name of responsible person - English: sajjad soofiSajjad Soofi Full name of responsible person - Persian: سجاد صوفی Street address - English: Keshavarz, Boulevard, Dr. Gharib Street, Keshavarz, Boulevard Street address - Persian: انتهای بلوار کشاورز – خیابان دکتر قریب City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۷۳۳۱۴۱ Phone: +98 21 6658 1625 Fax: Email: Imamhospital@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Akbari sari
Full name of responsible person - Persian: علی اکبری ساری
Street address - English: Keshavarz Boulevard, Corner of Qods Street, Central Administration of the University, 6th Floor, Office of the Vice Chancellor for Research and Technology
Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3698
Fax:
Email: vcr@sina.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Akbari Sari
Full name of responsible person - Persian: علی اکبری ساری
Street address - English: Vice Chancellor for Research and Technology, 6th Floor, Central Administration of the University, Corner of Qods Street, Keshavarz Boulevard
Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3698
Fax:
Email: vcr@sina.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ali Akbari sariSari Full name of responsible person - Persian: علی اکبری ساری Street address - English: Keshavarz BoulevardVice Chancellor for Research and Technology, Corner of Qods Street6th Floor, Central Administration of the University, 6th Floor, OfficeCorner of the Vice Chancellor for Research and TechnologyQods Street, Keshavarz Boulevard Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8163 3698 Fax: Email: vcr@sina.tums.ac.ir Web page address:
Protocol summary
Study aim
Determining the impact of peer-delivered digital storytelling on self-efficacy and rumination in patients with colorectal cancer
Design
This is a clinical trial with a control group, featuring parallel groups, single-blind, Non-random allocation , Phase I, conducted on 70 patients.
Settings and conduct
Study Location: The sections of the Cancer Institute at Imam Khomeini Hospital, Tehran; Participants: Individuals with colorectal cancer; Type of Blinding: Single-blind. Due to the potential for intervention leakage, the participants in the control group are sampled first, and after a short pause and the discharge of the last participant in the control group, the participants in the intervention group are sampled.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Individuals aged 18 to 65 years diagnosed with stage I-III colorectal cancer; willingness to participate in the research; proficiency in Persian; ownership and ability to use a smartphone; access to the internet and social media; literacy in reading and writing. Exclusion Criteria: Diagnosis of recurrent or metastatic colorectal cancer; known cognitive or psychiatric disorders as reported by the patient.
Intervention groups
Intervention Group: Participants in the intervention group will be invited to attend storytelling sessions in addition to their routine care. These sessions will consist of four two-hour online meetings with peers, researchers, and a psychologist. Control Group: Participants in the control group will receive standard care, which includes routine self-care education provided by a nurse during care procedures or upon discharge.
Main outcome variables
Self-efficacy; rumination
General information
Reason for update
The expected start date of participant recruitment was updated to align with the study's planned timeline.
Acronym
IRCT registration information
IRCT registration number:IRCT20241022063461N1
Registration date:2025-01-22, 1403/11/03
Registration timing:prospective
Last update:2025-09-28, 1404/07/06
Update count:1
Registration date
2025-01-22, 1403/11/03
Registrant information
Name
Sajjad Soofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3256 5624
Email address
s-soofi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Digital Storytelling by Peers and Routine Treatment on Changes in Self-Efficacy and Rumination in Individuals with Colorectal Cancer.
Public title
Digital storytelling in cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 18 to 65 with stage I-III colorectal cancer
Willingness to participate in the research
Proficiency in the Persian language
Possession of and ability to use a smartphone
Access to the internet and social media
Having at least basic literacy skills (reading and writing)
Exclusion criteria:
Having recurrent or metastatic colorectal cancer
Suffering from known cognitive or psychiatric disorders as reported by the patient
Suffering from physical disabilities such as blindness or deafness
Addiction to drugs, alcohol, or psychoactive substances
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the possibility of intervention leakage, the control group participants will enter the study first, and after a short break and the discharge of the last control group participant, the intervention group participants will enter the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation; Tehran University of
Street address
13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye Iran Street, Between Falamak Jonubi and Zarafshan, Shahrak-e Quds (West), Iran.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2024-10-06, 1403/07/15
Ethics committee reference number
IR.TUMS.FNM.REC.1403.127
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
The self-efficacy score in the General Self-Efficacy Questionnaire
Timepoint
Pre-test, immediately after, and one month later
Method of measurement
Scherer and Maddux General Self-Efficacy Questionnaire
2
Description
The rumination score in the Nolen-Hoeksema and Morrow Rumination Questionnaire
Timepoint
Pre-test, immediately after, and one month later
Method of measurement
Nolen-Hoeksema and Morrow Rumination Questionnaire
Secondary outcomes
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Intervention groups
1
Description
The intervention group: this intervention offers participants, in addition to routine care, the opportunity to participate in digital storytelling sessions aimed at improving self-efficacy and reducing rumination. These sessions will be held weekly over four weeks, focusing on storytelling films created by peers and overseen by specialists. During the sessions, participants will familiarize themselves with group norms and provide feedback on their own and others' experiences, while relevant scientific recommendations will be offered at each session. The meetings will include 14 to 16 participants, peers, a senior researcher, and a psychologist, conducted online at times chosen by the patients .To create digital stories, specific guidelines will be provided to selected individuals, who will be asked to write scenarios based on their experiences. These scenarios will then be reviewed by specialists and transformed into films. The production stages will include identifying images, creating a story flowchart, and combining the final media elements. At the end of the program, transportation costs for peers will be covered, and gifts will be presented as a form of appreciation.
Category
Rehabilitation
2
Description
Control group: They will receive standard care, which includes routine self-care education provided by a nurse during care procedures or at discharge. It is important to note that the control group will be followed up by phone every two weeks to assess if they meet the exit criteria for the study, at which point they may be removed from the study. One month after participating in the research, contact will be made with the research units, and the questionnaires will be completed again.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital, Tehran
Full name of responsible person
Sajjad Soofi
Street address
Dr. Gharib Street, Keshavarz, Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Vice Chancellor for Research and Technology, 6th Floor, Central Administration of the University, Corner of Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?