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

NCT07657728 | Completed

• 1 other identifier: IR. GOUMS. REC. 1402. 077
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Recurrence

Keywords

fear of breast cancer recurrence; positive psychology-based educational program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from Baseline in FCRI Triggers Subscale Score at 8 Weeks

  Baseline and 8 weeks (post-intervention)

• Change from Baseline in FCRI Severity Subscale Score at 8 Weeks

  Baseline and 8 weeks (post-intervention)

• Change from Baseline in FCRI Psychological Distress Subscale Score at 8 Weeks

  Baseline and 8 weeks (post-intervention)

• Change from Baseline in FCRI Functional Impairment Subscale Score at 8 Weeks

  Baseline and 8 weeks (post-intervention)

• Change from Baseline in FCRI Coping Strategies Subscale Score at 8 Weeks

  Baseline and 8 weeks (post-intervention)

Study Arms (2)

Positive Psychology Intervention

EXPERIMENTAL

Participants received 8 weekly 90-minute online positive psychology sessions

Behavioral: Positive Psychology-Based Educational Program

Control

NO INTERVENTION

Participants received no intervention during the study period

Interventions

Positive Psychology-Based Educational Program BEHAVIORAL

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.

Positive Psychology Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Golestan University of Medical sciences: lead

Study Sites (1)

Mirdamad Clinic

Gorgan, Golestan Province, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science (MSc) in Midwifery Counseling

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IR (1)