The aim of this study is to determine the effectiveness of group logotherapy on caregiving burden and quality of life among caregivers of patients with cancer.
Design
A randomized controlled clinical trial with parallel groups, single-blind, with a sample size of 60 participants. Randomization is conducted using a random numbers table.
Settings and conduct
This study will be conducted at Motahari Clinic. After obtaining written informed consent, participants will be randomly allocated to the intervention or control group. The intervention group will receive group logotherapy, while the control group will receive usual care. Outcome assessment will be performed by a blinded assessor.
Participants/Inclusion and exclusion criteria
Inclusion:
Primary caregivers of patients with cancer; more than 18 years old; able to attend group logotherapy; willing to participate; provided written consent, Severe psychiatric disorder
Exclusion:
individual or family conditions at entry preventing attendance.
Intervention groups
Intervention Group:Participants in the intervention group receive group logotherapy based on Viktor Frankl’s approach, following a structured protocol and established references.The intervention is delivered in 8 weekly group sessions, each lasting 90 minutes, over a total period of 8 weeks. Session content focuses on meaning-centered exploration, responsibility and attitudes toward suffering.
Control Group:Participants in the control group receive no logotherapy or structured psychological intervention during the study period and continue to receive routine care and standard services of the clinic as usual.
Main outcome variables
Caregiving burden; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251229068482N1
Registration date:2026-02-16, 1404/11/27
Registration timing:retrospective
Last update:2026-02-16, 1404/11/27
Update count:0
Registration date
2026-02-16, 1404/11/27
Registrant information
Name
Mohammad Hadi Owjfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 3478
Email address
mhadiog@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-15, 1404/10/25
Expected recruitment end date
2026-02-14, 1404/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the Effectiveness of Group Logotherapy on the Care Burden and Quality of life of Cancer Patients’ Caregivers
Public title
The Effects of logo therapy on the cancer patients’ caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Schools of Nursing and Midwifery, Management & Medical Information Sciences
Street address
Seventh Floor, Central Building, Shiraz University of Medical Sciences, Adjacent to the Red Crescent, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2025-11-01, 1404/08/10
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1404.095
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Specialized and Subspecialized Clinic