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

Overview

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

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.