Cancer SurvivorsNCT06867640
Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors
A study testing Forgiveness-Based Group Psychoeducation in people with Cancer Survivors, run by Hilal Merve Belen at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Forgiveness-Based Group Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2025to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülhane Health Sciences Institute
Ankara, Keçiören, 06010
About this study
Official title: Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors on Fear of Cancer Recurrence, Forgiveness and Psychiatric Symptoms: A Randomized Controlled Trial
This study aims to examine the effects of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric symptoms.
Read the 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.
- Conditions
- Cancer Survivors
- Being tested
- Forgiveness-Based Group Psychoeducation
- Keywords
- Cancer Survivors, Forgiveness, Psychoeducation, Fear of Cancer Recurrence, Quality of Life, Psychiatric Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forgiveness-Based Group PsychoeducationOther
The effect of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric conditions.
| Study group | Role | What they receive |
|---|---|---|
| Forgiveness-Based Group Psychoeducation | Experimental | 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. Receives: Other: Forgiveness-Based Group Psychoeducation |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartland Forgiveness Scale
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.
Measured: Baseline, 6 th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
Secondary outcomes (2)
Brief Symptom Inventory
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.
Measured: Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
Fear of Cancer Recurrence Inventory
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.
Measured: Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start2 Apr 2025
- Primary completion1 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Forgiveness-Based Group Psychoeducation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Merve Belen
- Sponsor type
- Other government
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Sponsor-investigator, Hilal Merve Belen, Lokman Hekim University
- Investigators
- Gamze Sarıkoç, Associate Professor, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867640
- Sponsor's protocol ID
- LokmanHekimU-HMB-1
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors on Fear of Cancer Recurrence, Forgiveness and Psychiatric Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06867640
- Acronym / sponsor ID
- LokmanHekimU-HMB-1
- Conditions
- Cancer Survivors
- Keywords
- Cancer Survivors, Forgiveness, Psychoeducation, Fear of Cancer Recurrence, Quality of Life, Psychiatric Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hilal Merve BelenOther government
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effects of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric symptoms.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Forgiveness-Based Group Psychoeducation
| Arm | Type | Receives |
|---|---|---|
| Forgiveness-Based Group Psychoeducation | Experimental | Other: Forgiveness-Based Group PsychoeducationForgiveness-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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forgiveness-Based Group PsychoeducationThe effect of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric conditions. | Other | Forgiveness-Based Group Psychoeducation |
Primary outcome
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)
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.
2 secondary outcomes
Brief Symptom Inventory
Time frame: Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Sarıkoç, Associate Professor study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forgiveness-Based Group Psychoeducation in people with Cancer Survivors, run by Hilal Merve Belen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.