Group Positive Psychology-Based Program for Fear of Breast Cancer Recurrence

The Effect of a Positive Psychology-Based Educational Program on Fear of Breast Cancer Recurrence in Women Attending Mirdamad Clinic in Gorgan, Iran: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether a group positive psychology-based educational program can reduce fear of cancer recurrence in women with a history of breast cancer who have completed primary treatment (surgery, chemotherapy, and radiotherapy).

The main question it aims to answer is:

Does an 8-week online positive psychology program reduce fear of cancer recurrence scores measured by the Fear of Cancer Recurrence Inventory (FCRI) compared to no intervention? Researchers will compare the intervention group (received 8 weeks of positive psychology training) to the control group (received no intervention during the study period) to see if the positive psychology program significantly reduces fear of cancer recurrence.

Participants will:

Complete online demographic and baseline Fear of Cancer Recurrence Inventory (FCRI) questionnaires (approximately 20 minutes) If assigned to the intervention group: Attend eight weekly 90-minute online positive psychology sessions based on Seligman's model via Skype Complete home exercises between sessions (e.g., recording three good things daily, writing a gratitude letter, practicing savoring techniques) Complete the FCRI questionnaire again immediately after the final intervention session.

If assigned to the control group: Receive no intervention during the study period and complete the FCRI questionnaire at the same time points as the intervention group; offered the same positive psychology training two months after the study ends

Study Overview

• Status: Completed
• Conditions: Cancer Recurrence
• Intervention / Treatment: Behavioral: Positive Psychology-Based Educational Program

Detailed Description

This study was a parallel-group, randomized controlled trial with a pretest-posttest design, conducted between July and September 2023 at Mirdamad Clinic in Gorgan, Iran. The study aimed to evaluate the effectiveness of a group positive psychology-based educational program on fear of cancer recurrence in women with a history of breast cancer.

Theoretical Framework:

The intervention was grounded in Seligman's positive psychology theory, which emphasizes the cultivation of positive emotions, engagement, relationships, meaning, and accomplishment (PERMA model). The program focused on identifying and using signature character strengths, gratitude, savoring, hope and optimism, post-traumatic growth through expressive writing, forgiveness, and altruism.

Intervention Protocol:

Participants assigned to the intervention group received eight weekly 90-minute online sessions delivered via the Skype application. Each session consisted of 45 minutes dedicated to reviewing homework from the previous session and 45 minutes focused on discussion and practice of new skills. A PDF booklet summarizing session content and home exercises was sent to participants via WhatsApp Messenger after each session.

The session content was as follows:

Session 1 (Introduction to Positive Psychology and Signature Strengths): Participants were introduced to positive psychology concepts and completed an online VIA-IS (Values in Action Inventory of Strengths) questionnaire to identify their top five signature strengths. Each participant shared a personal story illustrating one of their signature strengths with the group.

Session 2 (Three Good Things): Participants were instructed to record three positive events that occurred each day for one week and to reflect on the causes of these events. This exercise aimed to counter negativity bias and cultivate gratitude.

Session 3 (Savoring): Participants learned and practiced techniques for mindfully attending to and prolonging positive experiences, including sharing positive events with others, memory building, self-congratulation, and absorption in positive activities.

Session 4 (Hope and Optimism): Participants completed a guided visualization exercise identifying "closed doors" (past disappointments or failures) and "opened doors" (new opportunities that emerged). This exercise aimed to reframe negative experiences and foster hope.

Session 5 (Expressive Writing for Post-Traumatic Growth): Participants wrote about their most difficult life experience for 15-20 minutes daily for four consecutive days. This exercise aimed to process trauma and identify post-traumatic growth.

Session 6 (Gratitude Letter): Participants wrote a detailed letter of gratitude to someone who had helped them but whom they had never properly thanked. They were instructed to deliver the letter in person and read it aloud to the recipient.

Session 7 (Forgiveness): Participants completed a structured forgiveness exercise identifying a person toward whom they held a grudge, listing that person's positive attributes, and reflecting on the emotional impact of holding the grudge.

Session 8 (Review and Gift of Time): The final session reviewed all previous skills and concepts. Participants were instructed to give a "gift of time" to someone important by using one of their signature strengths to perform an act of kindness or service.

Control Group:

Participants assigned to the control group received no intervention during the study period. After the two-month follow-up assessment, they were offered the same positive psychology training as a courtesy.

Study Procedures:

After obtaining ethics approval and clinic permissions, the researcher screened patients at Mirdamad Clinic by reviewing medical records. Eligible women were contacted by telephone, provided with an explanation of the study objectives, and invited to participate. All participants provided written informed consent online.

Participants completed the demographic information form and the Fear of Cancer Recurrence Inventory (FCRI) online at baseline. They were then randomly assigned to the intervention or control group using block randomization with a block size of four. The randomization sequence was generated by an individual independent of the primary researcher, and group allocations were concealed in opaque, unlabeled envelopes until the start of the intervention.

The intervention group received the eight-week online positive psychology program as described above. Both groups completed the FCRI again immediately after the final intervention session. The outcome assessor was blinded to group allocation.

Intervention Fidelity:

To ensure intervention fidelity, all sessions were recorded and reviewed by an external monitor who was unaware of group assignment. The monitor used a checklist based on the content of each session to verify that all key components were delivered as planned. Additionally, the researcher completed a specialized online training course in positive psychology under the supervision of a doctoral-level psychologist before delivering the intervention.

Data Quality and Management:

Data were collected online using structured forms. The demographic information form and FCRI questionnaire were administered via an online platform with required fields to prevent missing data. Participant responses were automatically recorded in a secure database accessible only to the research team.

Normality of continuous variables was assessed using the Shapiro-Wilk test before statistical analysis. Outliers were not removed unless attributable to data entry error. No imputation methods were applied for missing data, as the final analysis included only participants with complete pre- and post-intervention data.

Statistical Analysis Plan:

Data were analyzed using SPSS version 18 (SPSS Inc., Chicago, IL, USA). Descriptive statistics, including mean, standard deviation, frequency, and percentage, were calculated for demographic and clinical variables. Between-group comparisons of continuous variables at baseline and post-intervention were performed using independent t-tests for normally distributed data and the Mann-Whitney U test for non-normally distributed data. Within-group comparisons (pre- to post-intervention) were conducted using paired t-tests for normally distributed data and the Wilcoxon signed-rank test for non-normally distributed data. Categorical variables were compared using the chi-square test or Fisher's exact test, as appropriate.

To adjust for baseline differences and control for potential confounders, analysis of covariance (ANCOVA) was performed on post-intervention total FCRI scores, with pre-intervention scores as the covariate. Subgroup analyses by ethnicity were also conducted. Effect sizes (partial eta squared) were calculated from ANCOVA results. The significance level for all statistical tests was set at p < 0.05.

Sample Size Justification:

The sample size was calculated based on a previous study by Ahmadi Qaragezlou et al. (2020), using the reported means and standard deviations for fear of cancer recurrence (intervention group: 0.9 ± 0.5; control group: 0.5 ± 0.2). Applying the formula for two independent groups with a 95% confidence level (Z₁-α/₂ = 1.96), 80% statistical power (Z₁-β = 0.84), and accounting for a 22% prevalence of fear of cancer recurrence and a 10% anticipated attrition rate, the required sample size was determined to be 19 participants per group, totaling 38 participants.

Participant Compensation:

As a token of appreciation, each participant received a certificate for a tree restored in the Zagros forests, symbolizing their contribution to environmental preservation.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Golestan Province
    • Gorgan, Golestan Province, Iran
      • Mirdamad Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Confirmed diagnosis of breast cancer (stages 1 to 3) by a specialist physician
2. Completion of all treatment phases, including surgery, chemotherapy, and radiotherapy
3. No documented history of personality or psychological disorders based on medical records
4. No current use of psychiatric or sedative medications
5. No prior participation in a psychological intervention similar to the one studied
6. Married
7. Residing in Golestan Province, Iran
8. At least elementary school education
9. Access to an electronic device (computer, tablet, or smartphone) to participate in online sessions
10. Willing to provide written informed consent

Exclusion Criteria:

1. Diagnosis of metastatic breast cancer
2. Diagnosis of recurrent breast cancer during the study period
3. Current use of alcohol, tobacco, or recreational drugs
4. Participation in yoga or meditation classes prior to the study
5. Hearing or speaking problems that would prevent participation in online sessions
6. Concurrent participation in other psychosocial programs or psychotherapy
7. Absence from more than two intervention sessions (for participants assigned to the intervention group)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Psychology Intervention; Participants received 8 weekly 90-minute online positive psychology sessions	Behavioral: Positive Psychology-Based Educational Program; Eight 90-minute weekly online group sessions based on Seligman's positive psychology model, delivered via Skype. Session topics include: introduction to positive psychology and signature strengths; three good things exercise; savoring techniques; hope and optimism; expressive writing for post-traumatic growth; gratitude letter; forgiveness; and review with gift of time. A PDF booklet containing session content and home exercises was sent to participants via WhatsApp after each session.
No Intervention: Control; Participants received no intervention during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Total Fear of Cancer Recurrence Inventory (FCRI) Score at 8 Weeks	The Fear of Cancer Recurrence Inventory (FCRI) is a 42-item self-report questionnaire that assesses fear of cancer recurrence over the preceding month. Each item is rated on a five-point Likert scale from 0 ("not at all" or "never") to 4 ("very much" or "always"). One item ("I believe that I am cured and my disease will not return") is reverse-scored. Total scores range from 0 to 168. Higher scores indicate greater fear of cancer recurrence. Change from baseline to 8 weeks (post-intervention) is reported. A negative change score indicates reduction in fear of cancer recurrence.	Baseline and immediately after the final intervention session (8 weeks from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in FCRI Triggers Subscale Score at 8 Weeks	The triggers subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 6 items assessing potential triggers that activate fear of cancer recurrence. Each item is scored from 0 to 4. Scores range from 0 to 24. Higher scores indicate greater fear triggered by cancer-related stimuli. Change from baseline to 8 weeks is reported; negative change indicates reduction.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Severity Subscale Score at 8 Weeks	The severity subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 8 items assessing the presence and severity of intrusive thoughts associated with fear of cancer recurrence. Each item is scored from 0 to 4. Scores range from 0 to 32. Higher scores indicate greater severity of fear. Change from baseline to 8 weeks is reported; negative change indicates reduction.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Psychological Distress Subscale Score at 8 Weeks	The psychological distress subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 9 items assessing emotional dysfunction associated with fear of cancer recurrence. Each item is scored from 0 to 4. Scores range from 0 to 36. Higher scores indicate greater psychological distress. Change from baseline to 8 weeks is reported; negative change indicates reduction.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Functional Impairment Subscale Score at 8 Weeks	The functional impairment subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 9 items assessing the effect of fear of cancer recurrence on functional areas of life. Each item is scored from 0 to 4. Scores range from 0 to 36. Higher scores indicate greater functional impairment. Change from baseline to 8 weeks is reported; negative change indicates improvement.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Coping Strategies Subscale Score at 8 Weeks	The coping strategies subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 4 items assessing strategies used to address fear of cancer recurrence. Each item is scored from 0 to 4. Scores range from 0 to 16. Higher scores indicate greater use of coping strategies. Change from baseline to 8 weeks is reported.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Insight Subscale Score at 8 Weeks	The insight subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 3 items assessing self-blame against the intensity of fear of cancer recurrence. Each item is scored from 0 to 4. Scores range from 0 to 12. Higher scores indicate greater insight into the excessiveness of fear. Change from baseline to 8 weeks is reported; negative change indicates reduction.	Baseline and 8 weeks (post-intervention)
Change from Baseline in FCRI Reassurance Subscale Score at 8 Weeks	The reassurance subscale of the Fear of Cancer Recurrence Inventory (FCRI) consists of 3 items assessing reassurance-seeking behavior through examination and medical counseling. Each item is scored from 0 to 4. Scores range from 0 to 12. Higher scores indicate greater reassurance-seeking behavior. Change from baseline to 8 weeks is reported; negative change indicates reduction.	Baseline and 8 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: Golestan University of Medical sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: June 13, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: fear of breast cancer recurrence; positive psychology-based educational program
• Other Study ID Numbers: IR. GOUMS. REC. 1402. 077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No