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

13 czerwca 2026 zaktualizowane przez: Maryam Ghanbarzade, Golestan University of Medical sciences

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

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

38

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Positive Psychology Intervention
Participants received 8 weekly 90-minute online positive psychology sessions
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.
Brak interwencji: Control
Participants received no intervention during the study period

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Total Fear of Cancer Recurrence Inventory (FCRI) Score at 8 Weeks
Ramy czasowe: Baseline and immediately after the final intervention session (8 weeks from baseline)
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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in FCRI Triggers Subscale Score at 8 Weeks
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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
Ramy czasowe: Baseline and 8 weeks (post-intervention)
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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lipca 2023

Zakończenie podstawowe (Rzeczywisty)

30 września 2023

Ukończenie studiów (Rzeczywisty)

30 września 2023

Daty rejestracji na studia

Pierwszy przesłany

13 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • IR. GOUMS. REC. 1402. 077

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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