- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867640
Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors
Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors on Fear of Cancer Recurrence, Forgiveness and Psychiatric Symptoms: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a randomized controlled experimental study with a pre-test-post-test and follow-up design to examine the effects of forgiveness-based group psychoeducation on fear of cancer recurrence, forgiveness and psychiatric symptoms of cancer survivors.
The aim is to evaluate the effects of a forgiveness-based psychoeducation program on cancer survivors. After the "Informed Voluntary Consent Form" is obtained from individuals who agree to participate in the study, the Introductory Information Form, Heartland Forgiveness Scale, Fear of Relapse Inventory and Brief Symptom Inventory will be applied. Pre-tests will be applied to the sample determined by an independent statistician. Then, participants will be divided into intervention and control groups by simple randomization method. Face-to-face forgiveness-based psychoeducation will be applied to the intervention group in 90-minute sessions once/twice a week, totaling 6 sessions. In the last session of psychoeducation, a post-test ("Introductory Information Form", "Heartland Forgiveness Scale", "Fear of Relapse Inventory" and "Brief Symptom Inventory") will be administered to both the intervention and control groups. The first follow-up test of the study will be administered to both the intervention and control groups 1 month after the post-test, and the second follow-up test of the study will be administered 3 months after the post-test. After the completion of the study and the measurements, it is planned to provide forgiveness-based psychoeducation to the participants in the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Keçiören
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Ankara, Keçiören, Turkey, 06010
- Gülhane Health Sciences Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written and verbal consent to participate in the study
- Understanding and speaking Turkish
- Being over 18 years old
- Not having any visual, hearing or mental disabilities
- Having been diagnosed with cancer, treated with curative intent and having completed major treatments (surgery, radiotherapy, chemotherapy) within the last 5 years
Exclusion Criteria:
- Not volunteering to participate in research
- Having a visual, hearing or mental disability
- Agreeing to participate in another psychoeducational program conducted simultaneously with the research
- Inability to communicate in Turkish
- Having previously received training in forgiveness and/or coping with fear of relapse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No Intervention
After the follow-up tests were completed, it was planned to implement the 6-session forgiveness-based group psychoeducation applied to the intervention group in the same way upon the request of the control group.
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Experimental: Forgiveness-Based Group Psychoeducation
Forgiveness-based group psychoeducation to be conducted with the experimental group is planned as 6 sessions.
The sessions are planned to be conducted in 3 groups of 8-10 people.
The duration of a session is planned to be approximately 90 minutes.
Group psychoeducation with the experimental group will be conducted face-to-face every week.
The appropriate day for the sessions will be decided with the members of each group.
The same group sessions will be conducted on the same day and time every week.
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The effect of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heartland Forgiveness Scale
Time Frame: Baseline, 6 th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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The scale, which evaluates the level of forgiveness and consists of 18 items, consists of three sub-dimensions: "forgiveness of self", "forgiveness of others" and "forgiveness of the situation".
The items of the Likert-type scale are evaluated according to a 7-point evaluation scale and the evaluation is answered as "does not reflect me at all" (1 point), "does not reflect me very much" (3 points), "reflects me a little" (5 points) and "reflects me completely" (7 points).
Items 2, 4, 6, 7, 9, 11, 13, 15 and 17 in the scale items are scored reversely.
The scale is evaluated according to total and sub-scale scores and there is no cut-off score.
High scores obtained from each of the sub-dimensions of the scale indicate a high or low level of forgiveness in the relevant sub-dimension.
The total forgiveness score is formed by summing the scores of the sub-dimensions of the scale.
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Baseline, 6 th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fear of Cancer Recurrence Inventory
Time Frame: Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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The scale, which has a five-point Likert structure, consists of 42 items and 7 sub-dimensions.
These sub-dimensions are; triggers (items 1-8 and 9-17), psychological distress (items 18-21), functional disorders (items 22-27), insight (items 28-30), self-relaxation methods (items 31-33), coping methods (items 34-42).
The scale, which does not have any cut-off point, is scored as 0-4 points.
It is obtained by adding the questions in each sub-dimension straight, except for question 43.
The total scores that can be obtained from the scale are between 0-168, and as the score increases, it is judged that the fear of relapse increases.
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Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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Brief Symptom Inventory
Time Frame: Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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It is a Likert-type scale and the items are scored by rating them between 0 and 4, with the statements "not at all" and "a lot".
People who will fill out the scale are asked to read each item separately and indicate how much each of these symptoms has bothered them in the last week, including that day.
When the total for each subscale is divided by the number of items in that subscale, a score for that dimension is obtained.
Brief Symptom Inventory subscale dimensions and items; anxiety; items 12, 13, 28, 31, 32, 36, 38, 42, 43, 45, 46, 47, 49; depression; items 9, 14, 16, 17, 18, 19, 20, 25, 27, 35, 37, 39; negative self; Items 15, 21, 22, 24, 26, 34, 44, 48, 50, 51, 52, 53; somatization; items 2, 5, 7, 8, 11, 23, 29, 30, 33; hostality; items 1, 3, 4, 6, 10, 40, 41.
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Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Introductory Information Form
Time Frame: Baseline, 1st month follow-up, 3rd month follow-up (Pre-test-post-test follow-up experimental design)
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It was created by the researchers in line with the literature information in order to determine the participants' sociodemographic (age, gender, marital status, education level, etc.) and diagnosis-treatment process-related characteristics.
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Baseline, 1st month follow-up, 3rd month follow-up (Pre-test-post-test follow-up experimental design)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gamze Sarıkoç, Associate Professor, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LokmanHekimU-HMB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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