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IRCT20251229068482N1 IRCT 2026-02-16 Shiraz University of Medical Sciences The Effects of logo therapy on the cancer patients’ caregivers Studying the Effectiveness of Group Logotherapy on the Care Burden and Quality of life of Cancer Patients’ Caregivers 2026-01-15 anticipated 60 Complete https://irct.ir/trial/88410 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, after confirming eligibility criteria and obtaining written informed consent, participants were allocated to the intervention and control groups using simple randomization with a 1:1 allocation ratio. The unit of randomization was the individual, and neither cluster randomization nor stratified randomization was applied. The random allocation sequence was generated prior to participant recruitment by an independent researcher using a random numbers table. Group assignment was determined based on whether the generated numbers were odd or even, and a complete allocation list was prepared in advance. This researcher was not involved in participant recruitment or intervention implementation. To ensure allocation concealment, the prepared random sequence was placed in sequentially numbered, opaque, sealed, and impermeable envelopes. The envelopes were opened in order of participants’ entry into the study, ensuring that group assignment was not predictable for either the researcher or the participants prior to allocation, Blinding description: Due to the nature of the intervention, which involved group logotherapy, blinding of participants and health care providers delivering the intervention was not feasible. Participants were aware of whether they received the intervention, and the therapist was directly involved in delivering the sessions. The principal investigator was also aware of group allocation because of involvement in the design and implementation of the study. To minimize potential bias in outcome assessment, the outcome assessor responsible for collecting questionnaires and evaluating outcome variables was kept blinded to group allocation. Data were provided to the assessor without any indication of the participants’ group assignment. Data analysis was performed after completion of data collection, and the data analyst was aware of the original group allocation. Given the academic nature and limited scale of the study, no Data Safety and Monitoring Committee was established. All participants provided written informed consent after receiving complete information about the study objectives and procedures. N/A Cancer. Intervention 1: Intervention Group:Participants in this group receive group logotherapy through a structured 8-session weekly program, each session lasting 90 minutes, based on Viktor Frankl’s logotherapy principles. Session content includes:Introduction to logotherapy conceptsIdentifying personal values and sources of meaningReviewing caregiving burden and attitude toward sufferingTransforming suffering into growth opportunitiesEnhancing hope and psychological resilienceClarifying caregiving roleIntegrating meaning into daily lifeAll sessions are conducted by a trained therapist, and participants receive identical content throughout the intervention period.Control Group:Participants in this group receive no structured logotherapy intervention and continue with routine care and standard clinic services. Intervention 2: Control group: Participants in the control group will not receive any group logotherapy intervention during the study period and will receive only the usual care and services routinely provided at Shahid Motahari Clinic. No additional educational or psychological intervention will be provided to this group during the study period. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan to share individual participant data from this study. No further information is available.
public Mohammad Hadi Owjfard
No 21, Rezvan residential complex, North Motahari Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 7186899517 +98 71 3620 3478 mhadiog@gmail.com Shiraz University of Medical Sciences scientific Shahrzad YektaTalab
Fatemeh School of Nursing and Midwifery, Entrance to Namazee Hospital, Namazee Square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4252 shahrzadyekta@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Voluntary Willingness to Participate in the Study and Signing the Informed Consent Form Membership in the Patient’s Family and Direct Responsibility for Daily Care A Minimum History of Three Months of Direct Caregiving With an Average of at Least Two Hours per Day for a Patient With Cancer (Based on Self-Report in the Demographic Form) Aged eighteen years or older. No Receipt of Payment or Salary for Caregiving Ability to Read and Write in the Persian Language No History of Severe Psychiatric Disorders or Cognitive Impairment Based on Self-Report or Medical Records 18 years no limit Both History of substance abuse or current use of psychoactive medications at the time of study entry. Inability to plan for attendance at group logotherapy sessions at the time of study entry. C00-C97 Malignant neoplasms Behavior Behavior Intervention Group:Participants in this group receive group logotherapy through a structured 8-session weekly program, each session lasting 90 minutes, based on Viktor Frankl’s logotherapy principles. Session content includes:Introduction to logotherapy conceptsIdentifying personal values and sources of meaningReviewing caregiving burden and attitude toward sufferingTransforming suffering into growth opportunitiesEnhancing hope and psychological resilienceClarifying caregiving roleIntegrating meaning into daily lifeAll sessions are conducted by a trained therapist, and participants receive identical content throughout the intervention period.Control Group:Participants in this group receive no structured logotherapy intervention and continue with routine care and standard clinic services. Control group: Participants in the control group will not receive any group logotherapy intervention during the study period and will receive only the usual care and services routinely provided at Shahid Motahari Clinic. No additional educational or psychological intervention will be provided to this group during the study period. Caregiving burden score among caregivers of patients with cancer measured using the Zarit Burden Interview. Timepoint: Caregiving burden will be measured at two time points; at baseline before the start of the group logotherapy intervention; and at the end of the intervention period immediately after completion of the group logotherapy sessions. Method of measurement: Caregiving burden among caregivers of patients with cancer will be measured using the Zarit Burden Interview questionnaire. Quality of life score among caregivers of patients with cancer measured using the World Health Organization Quality of Life Brief questionnaire. Timepoint: Quality of life will be measured at two time points; at baseline before the start of the group logotherapy intervention; and at the end of the intervention period immediately after completion of all group logotherapy sessions. Method of measurement: Quality of life among caregivers of patients with cancer will be measured using the World Health Organization Quality of Life Brief questionnaire. Shiraz University of Medical Sciences Approved 2025-11-01 Ethics Committee of the Schools of Nursing and Midwifery, Management & Medical Information Sciences Seventh Floor, Central Building, Shiraz University of Medical Sciences, Adjacent to the Red Crescent, Zand Street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)