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Examining the effectiveness of patient-centered patient-centered decision-making and happiness education on psychological well-being in women at risk of cancer-related infertility

Comparison of the Effectiveness of Patient-Centered Decision-Making Counseling and Happiness Training Versus Standard Care in Improving Psychological Well-Being in women at risk of cancer-related infertility

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221109056451N5
Enrollment
128
Registered
2025-05-10
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduced psychological well-being in women at risk of cancer-related infertility. Adjustment disorders

Interventions

Intervention 1: Intervention group: The intervention group consists of 5 personalized counseling sessions conducted by a trained midwifery counseling student. The sessions are held both in person and

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 40 years Recently diagnosed with various types of cancer including breast cancer, Hodgkin’s lymphoma, leukemia, gastrointestinal cancer, non-Hodgkin’s lymphoma, ovarian cancer, endometrial cancer, and sarcomas Women who are about to start radiotherapy or chemotherapy No psychological disorders: as diagnosed by a clinical psychologist

Exclusion criteria

Exclusion criteria: Critical medical conditions or newly developed illnesses (unrelated to the study) that prevent participation Inability to understand the informed consent or lack of capacity to cooperate with study procedures

Design outcomes

Primary

MeasureTime frame
Psychological well-being score measured by the 18-item Ryff Psychological Well-being Scale. Timepoint: Before the intervention (baseline) and at the end of the fifth session (approximately five weeks after the start of the intervention). Method of measurement: Ryff Psychological Well-being Scale (18-item version), rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree), with a total score range from 18 to 108.

Secondary

MeasureTime frame
Emotional state of participants after the intervention. Timepoint: Before the intervention, and four weeks after the last counseling session. Method of measurement: Measured by the Positive and Negative Affect Schedule (PANAS), a 20-item self-report scale with two subscales assessing positive and negative affect. Each item is rated on a five-point Likert scale from 1 (very slightly or not at all) to 5 (extremely). The internal consistency (Cronbach's alpha) for the positive affect scale is 0.88 and for the negative affect scale is 0.87.;Level of decisional conflict regarding fertility preservation after the intervention. Timepoint: Before the intervention and four weeks after the last counseling session. Method of measurement: Assessed by the Decisional Conflict Scale–Low Literacy version, a 10-item self-report questionnaire measuring decisional uncertainty and contributing factors. The scoring yields a total score between 0 (no conflict) and 100 (extreme conflict), with higher scores indicating greater decisional conflict.;Fertility preservation referral rates after the intervention. Timepoint: From the first counseling session to four weeks after the last session. Method of measurement: Referral status will be recorded based on documentation and patient records from the infertility clinic. The number and percentage of participants referred to fertility preservation services will be calculated.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Bakouei

Babol University of Medical Sciences

bakouei2004@yahoo.com+98 11 3219 5313

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026