Protocol summary
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Study aim
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Determining the impact of peer-delivered digital storytelling on self-efficacy and rumination in patients with colorectal cancer
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Design
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This is a clinical trial with a control group, featuring parallel groups, single-blind, Non-random allocation , Phase I, conducted on 70 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Self-efficacy; rumination
General information
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Reason for update
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The expected start date of participant recruitment was updated to align with the study's planned timeline.
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Acronym
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IRCT registration information
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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
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Registration date
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2025-01-22, 1403/11/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-08-23, 1404/06/01
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Expected recruitment end date
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2025-12-21, 1404/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Digital storytelling in cancer
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-10-06, 1403/07/15
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Ethics committee reference number
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IR.TUMS.FNM.REC.1403.127
Health conditions studied
1
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Description of health condition studied
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Colorectal cancer
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ICD-10 code
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C19
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ICD-10 code description
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Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
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Description
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The self-efficacy score in the General Self-Efficacy Questionnaire
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Timepoint
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Pre-test, immediately after, and one month later
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Method of measurement
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Scherer and Maddux General Self-Efficacy Questionnaire
2
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Description
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The rumination score in the Nolen-Hoeksema and Morrow Rumination Questionnaire
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Timepoint
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Pre-test, immediately after, and one month later
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Method of measurement
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Nolen-Hoeksema and Morrow Rumination Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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- Contributors' Data File (All Data)
- Clinical Study Report (All Data)
- Informed Consent Form (All Data)
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When the data will become available and for how long
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Access will begin in the Spring of 2025.
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To whom data/document is available
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Researchers employed in academic and scientific institutions.
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Under which criteria data/document could be used
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In case of using the data in scientific research
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From where data/document is obtainable
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Sajjad Soofi
sajjadsoofi205@gmail.com
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What processes are involved for a request to access data/document
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Applicants can submit their requests via email, and a response will be provided within a maximum of 24 hours after receiving the email.
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Comments
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