NCT06867640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

August 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 23, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Cancer SurvivorsForgivenessPsychoeducationFear of Cancer RecurrenceQuality of LifePsychiatric Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)

  • Fear of Cancer Recurrence Inventory

    Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)

Other Outcomes (1)

  • Introductory Information Form

    Baseline, 1st month follow-up, 3rd month follow-up (Pre-test-post-test follow-up experimental design)

Study Arms (2)

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.

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.

Interventions

The effect of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric conditions.

Forgiveness-Based Group Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülhane Health Sciences Institute

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

Study Officials

  • Gamze Sarıkoç, Associate Professor

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The process of assigning participants to groups will be carried out by a statistician outside the study using the simple randomization method and will be hidden from the researcher until the application begins. Since the assignment to groups will be made after informed consent is obtained, the participants will be blinded (single blind). In addition, the statistician will also be blinded in order to reduce statistical analysis and reporting bias. Without specifying which group (intervention and control group) the data belong to, they will be coded and transferred to the database (group A, group B), and the data will be analyzed and reported.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Forgiveness-Based Group Psychoeducation
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 10, 2025

Study Start

April 2, 2025

Primary Completion

July 1, 2025

Study Completion

July 14, 2025

Last Updated

August 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations