Oncofertility Support Scale

1. Abstract

The Oncofertility Support Scale (OSS) is a specialized, multidimensional psychometric instrument designed to evaluate the delivery, breadth, and perceived quality of reproductive health and oncofertility support provided to reproductive-aged cancer patients, specifically young women navigating breast cancer diagnoses and treatments. Developed by Li Hu, Pui Hing Chau, Chanchan Wu, and Edmond Pui Hang Choi (2025), the instrument emerged in response to persistent clinical and empirical evidence that young breast cancer patients experience widespread unmet informational, decision-making, and psychosocial needs concerning treatment-induced gonadotoxicity, premature ovarian insufficiency, and post-treatment fertility preservation. While historical instruments primarily assessed objective patient knowledge or general social support, the OSS isolates the specific operational behaviors, professional counseling initiatives, and communicative networks that constitute true oncofertility care.

Comprising 19 items organized into a robust four-factor structure, the OSS measures: (1) Information Support on Fertility Impact (4 items), (2) Information Support on Fertility Preservation (3 items), (3) Fertility and Sexual Guidance (4 items), and (4) Fertility Communication and Supportive Networks (8 items). The instrument was standardized in an initial clinical cohort of 343 young female breast cancer survivors aged 18 to 45 years in China, utilizing an analytical framework combining exploratory factor analysis (EFA; n = 123) and confirmatory factor analysis (CFA; n = 220). Psychometric assessment demonstrated outstanding internal consistency, evidenced by an overall Cronbach’s α of 0.95 and a McDonald’s ω of 0.95. Confirmatory structural modeling revealed solid goodness-of-fit metrics, including a Comparative Fit Index (CFI) of 0.914 and a Root Mean Square Error of Approximation (RMSEA) of 0.079. The scale exhibited exemplary content validity (content validity index = 0.95), divergent/convergent validity supported by average variance extracted values exceeding 0.63, and established measurement invariance across patient age strata and baseline fertility preferences. The OSS serves as a standardized evaluative and clinical diagnostic instrument for psycho-oncology, nursing, reproductive endocrinology, and healthcare quality assurance.

2. Keywords

Oncofertility Support Scale, psycho-oncology, breast cancer survivorship, fertility preservation, reproductive health, psychometrics, patient-reported outcome measures, gonadotoxicity, health communication, supportive care

3. Authors

The Oncofertility Support Scale was conceptualized, developed, and empirically validated by an interdisciplinary team of nurse-scientists and clinical health researchers specializing in psycho-oncology, supportive cancer care, and quantitative health measurement at leading research institutions in Hong Kong:

• Li Hu, PhD, RN: School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China. Dr. Hu focuses on reproductive survivorship, supportive cancer interventions, and reproductive decision-making among adolescent and young adult (AYA) oncology cohorts.
• Pui Hing Chau, PhD: Associate Professor, School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China. Dr. Chau is a biostatistician and psychometrician specializing in longitudinal modeling, patient-reported outcomes, and advanced structural equation modeling.
• Chanchan Wu, PhD: School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China. Dr. Wu’s research encompasses clinical nursing interventions, psychosocial oncology, and chronic disease adaptation.
• Edmond Pui Hang Choi, PhD: Corresponding Author (Email: [email protected]), Assistant Professor, School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China. Dr. Choi specializes in health-related quality of life, health economics, psychometrics, and supportive care oncology.

4. Purpose

The primary clinical and empirical purpose of the Oncofertility Support Scale (OSS) is to provide a standardized, psychometrically sound diagnostic metric for quantifying the degree, scope, and adequacy of oncofertility-specific supportive care received by young adult female cancer patients. Across global healthcare jurisdictions, breast cancer remains the most frequently diagnosed malignancy among reproductive-aged women. Modern multimodal therapeutic interventions—such as systemic alkylating chemotherapy regimens, extended endocrine manipulations (e.g., tamoxifen, aromatase inhibitors, ovarian function suppression with GnRH agonists), and targeted therapies—have achieved unprecedented 5-year survival rates exceeding 90% for early-stage disease. However, these life-saving interventions frequently confer severe gonadotoxic sequelae, precipitating premature ovarian insufficiency, irreversible iatrogenic infertility, sexual dysfunction, and intense psychological distress.

Despite internationally endorsed clinical practice guidelines issued by the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), and regional oncology associations mandating that healthcare providers address potential treatment-induced reproductive risks and offer timely referrals for fertility preservation prior to starting antineoplastic therapy, deep deficits persist in clinical implementation. Clinicians consistently report institutional barriers, including time constraints, lack of familiarity with assisted reproductive technologies, prioritizing immediate survival over survivorship outcomes, and discomfort discussing sensitive topics like sexuality and family building.

Historically, research evaluating oncofertility interactions has faced substantial psychometric limitations. Investigators frequently relied on unvalidated, single-item questions, ad-hoc institutional satisfaction surveys, or tools such as the Fertility Information Support Scale. Crucially, earlier instruments often conflated two conceptually distinct constructs: (1) a patient’s objective reproductive health literacy or factual recall, and (2) the systematic delivery of supportive, informational, and communicative care by the healthcare team and personal support networks. When a patient scores poorly on factual recall tests, it remains unclear whether the clinician failed to deliver adequate guidance or whether the patient encountered cognitive processing challenges under acute diagnostic distress. The OSS was specifically designed to resolve this conceptual conflation by measuring the structured provision of support across informational, medical, physical, and relational dimensions.

In clinical practice, the OSS functions as an operational audit tool that identifies specific institutional gaps in oncology survivorship programs. For example, by analyzing subscale performances, clinical centers can recognize if their oncologists routinely explain fertility loss risks while consistently failing to discuss sexual health, post-treatment contraception, or referrals to specialized reproductive endocrinologists. In clinical trial settings, the OSS serves as a definitive Patient-Reported Outcome Measure (PROM) to evaluate the efficacy of oncofertility decision aids, dedicated fertility nurse navigators, interdisciplinary reproductive tumor boards, and peer-to-peer psychosocial support programs.

5. Psychological Construct

The psychological construct evaluated by the instrument is Oncofertility Support, defined as a multidimensional biopsychosocial continuum of healthcare service delivery, guidance, practical instruction, and communicative scaffolding that facilitates informed reproductive decision-making, protects patient agency, and mitigates fertility-related existential and psychological distress during and following antineoplastic treatment. Grounded in holistic survivorship care, the construct integrates medical oncology, reproductive endocrinology, sexual medicine, and social psychology into four distinct but correlated sub-constructs:

Dimension 1: Information Support on Fertility Impact (Items 1, 2, 3, 4)

This dimension operationalizes the medical information provided by oncology clinicians regarding how cancer treatments and underlying genetic predispositions affect short-term and long-term reproductive capacity. It assesses whether clinicians communicate clearly about:

• The mechanism through which specific antineoplastic therapies (e.g., anthracyclines, cyclophosphamide, pelvic radiation, long-term endocrine suppression) reduce the primordial follicle pool.
• The distinction between transient treatment-induced amenorrhea and permanent ovarian failure.
• The potential implications of hereditary cancer mutations (e.g., BRCA1, BRCA2, PALB2) for offspring health and family-building timelines.
• The biological and chronological window within which reproductive decision-making must occur prior to systemic therapy initiation.

Dimension 2: Information Support on Fertility Preservation (Items 5, 6, 7)

While the first dimension measures communication regarding physiological risk, this subscale quantifies the active provision of evidence-based fertility preservation options. It assesses whether patients receive structured guidance on:

• Available medical and laboratory interventions (e.g., mature oocyte cryopreservation, embryo cryopreservation, ovarian tissue cryopreservation, and pharmacological ovarian suppression using GnRH agonists during chemotherapy).
• The associated procedural timelines, systemic hormonal stimulation risks, cycle cancellation rates, and realistic live-birth probabilities.
• Timely pathways for specialist referrals to reproductive endocrinologists, financial counseling regarding out-of-pocket costs, and legal documentation regarding gamete storage.

Dimension 3: Fertility and Sexual Guidance (Items 9, 10, 11, 12)

This subscale captures practical guidance on sexual functioning, bodily changes, and safe reproductive practices throughout cancer management. Historically neglected during acute oncology encounters, these practical issues are central to survivorship quality of life. The dimension evaluates whether healthcare professionals provide counsel on:

• Mitigating treatment-induced sexual morbidity, such as dyspareunia, vaginal dryness, pelvic floor hypertonicity, and loss of libido resulting from chemical castration or premature menopause.
• Safe, non-hormonal sexual health interventions (e.g., vaginal moisturizers, hyaluronic acid preparations, silicone lubricants, pelvic physical therapy).
• Teratogenicity prevention, including non-hormonal contraception counseling during active systemic therapy.
• Long-term prospects and safety guidelines for post-treatment pregnancy, lactation, and breastfeeding considerations following conservative breast surgery or radiation.

Dimension 4: Fertility Communication and Supportive Networks (Items 15, 16, 17, 18, 19, 20, 21, 22)

The largest subscale addresses the psychosocial, relational, and emotional scaffolding supporting the patient. Grounded in interpersonal communication theories, it assesses:

• The degree to which the healthcare ecosystem encourages and facilitates open dialogue about reproductive values, motherhood desires, and emotional distress.
• Communication support within the patient’s personal relationships, assisting them in discussing reproductive futures, shared grief, and family planning with romantic partners and immediate family.
• Integration with external peer-support networks, cancer support groups, and patient advocacy organizations that reduce isolation and support psychological adaptation to potential infertility.

6. Theoretical Framework

The Oncofertility Support Scale is theoretically grounded in the integration of three foundational frameworks from health psychology, clinical communication, and stress adaptation: the Biopsychosocial Model of Medicine (Engel, 1977), the Transactional Model of Stress and Coping (Lazarus & Folkman, 1984), and the Theory of Supportive Communication (Burleson, 2003; House, 1981).

Under George Engel’s Biopsychosocial Model, illness and clinical care cannot be separated into strictly biological pathologies. In reproductive-aged oncology, a patient’s response to breast cancer cannot be isolated to tumor histology or cytotoxic eradication. The potential loss of fertility triggers profound existential, developmental, and social disruption. Erikson’s developmental theory identifies young adulthood as characterized by intimacy versus isolation and generative family planning. When cancer disrupts these normative developmental milestones, it threatens a patient’s core self-concept, femininity, and identity. Consequently, supportive care must balance biological preservation with psychological security and social re-integration, a conceptual architecture operationalized across the four OSS dimensions.

Lazarus and Folkman’s Transactional Model of Stress and Coping provides the second theoretical foundation. Upon receiving a life-threatening breast cancer diagnosis, patients undergo primary cognitive appraisal, evaluating the immediate threat to survival. Simultaneously, learning that antineoplastic treatments threaten future motherhood initiates a parallel appraisal of loss and reproductive disruption. Secondary appraisal evaluates the resources available to manage this threat. The OSS quantifies the delivery of coping resources provided by the external medical and psychosocial environment:

• Informational Support operates as a cognitive appraisal resource, transforming an ambiguous threat into an actionable set of clinical options.
• Practical Sexual and Fertility Guidance provides instrumental coping resources, reducing symptom-related distress and preventing avoidable adverse events (e.g., unintended conception during teratogenic therapy).
• Communication and Social Networks provide emotional and relational resources, enabling cognitive reframing, mutual dyadic coping with romantic partners, and resilience.

Finally, the scale incorporates James House’s taxonomy of social support and Burleson’s Theory of Supportive Communication. House categorized social support into four fundamental behaviors: informational (advice, data, suggestions), instrumental (tangible aid, referrals, direct intervention), emotional (empathy, listening, trust), and appraisal (feedback, validation, affirmation). The OSS captures each of these modes within the clinical cancer context. By shifting measurement away from passive patient knowledge toward communicative interactions and institutional service delivery, the OSS operationalizes support as an interactive, relational process rather than an isolated cognitive state.

7. Validity

The validation methodology for the Oncofertility Support Scale utilized multiple psychometric testing procedures to confirm that the tool accurately operationalizes its theoretical construct.

Content and Face Validity

Content validity was evaluated using a mixed panel of clinical experts (including medical oncologists, breast surgical oncologists, reproductive endocrinologists, psycho-oncology specialists, and senior oncology nursing faculty) and patient stakeholder representatives. The developers calculated the Scale-Content Validity Index (S-CVI) and Item-Content Validity Index (I-CVI) utilizing Lawshe’s (1975) quantitative criteria for item clarity, medical accuracy, clinical relevance, and domain representation. The resulting overall Scale-CVI was 0.95, demonstrating exceptional content validity and consensus that the 19 retained items comprehensively cover clinical oncofertility practice without introducing extraneous medical jargon.

Construct and Structural Validity

Construct validity was examined using a split-sample structural equation modeling approach (EFA on n = 123; CFA on n = 220). Confirmatory modeling demonstrated strong factor loadings for all 19 items onto their designated latent constructs, ranging from moderate to high values. Convergent validity was substantiated through the calculation of Average Variance Extracted (AVE) across all four latent subscales. In every factor, the AVE score surpassed the standard psychometric threshold of 0.50 (with reported subscale AVE metrics exceeding 0.63), verifying that the underlying latent constructs account for more than 60% of the variance observed among their respective indicators.

Discriminant validity was established using the Fornell-Larcker criterion, which requires that the square root of each factor’s AVE exceed its inter-factor correlations with any other latent dimension. The four factors maintained sufficient unique variance to confirm that while they all contribute to the overarching construct of oncofertility care, they capture distinct clinical domains.

Convergent and Criterion Validity

To examine convergent and divergent relations with broader supportive care instruments, the OSS was correlated with the established Medical Outcomes Study Social Support Survey (MOS-SSS; Sherbourne & Stewart, 1991). Psychometric hypotheses predicted that while the OSS would correlate positively with general medical social support, the magnitude would remain modest. The empirical correlation obtained was r = 0.18 (p < 0.01). This weak-to-moderate positive association confirms that oncofertility support represents a highly specialized, clinical domain that cannot be captured by broad social support instruments.

Known-Groups Validity

Known-groups validity was tested across age cohorts. Based on clinical literature indicating that older reproductive-aged patients (e.g., ages 35–45) experience more frequent omissions in fertility counseling compared to younger cohorts (e.g., ages 18–29), developers hypothesized significant differences in subscale scores across age brackets. Analysis of variance (ANOVA) supported this hypothesis: patients under age 30 reported significantly higher perceived support for Information Support on Fertility Preservation than older cohorts (p < 0.05), confirming the scale’s sensitivity to documented real-world clinical disparities.

8. Reliability

The Oncofertility Support Scale was evaluated for internal consistency and score precision using both traditional and modern psychometric indicators. In classical test theory, Cronbach’s alpha is standard, yet it is constrained by the assumption of essential tau-equivalence—the assumption that each item contributes equally to the latent construct with identical factor loadings. To avoid this limitation, the scale developers calculated McDonald’s omega coefficient alongside Cronbach’s alpha.

The total 19-item OSS achieved an overall Cronbach’s α of 0.95 and an identical McDonald’s ω of 0.95. These values reflect high internal consistency, well above the standard 0.70 benchmark for research instruments and the 0.90 threshold required for individual-level clinical decision-making. Across individual subscales, internal consistency metrics remained consistently strong:

• Information Support on Fertility Impact (4 items): Cronbach’s α > 0.88; McDonald’s ω > 0.88.
• Information Support on Fertility Preservation (3 items): Cronbach’s α > 0.85; McDonald’s ω > 0.86.
• Fertility and Sexual Guidance (4 items): Cronbach’s α > 0.87; McDonald’s ω > 0.87.
• Fertility Communication and Supportive Networks (8 items): Cronbach’s α > 0.92; McDonald’s ω > 0.92.

Composite reliability (CR) coefficients for all four latent factors exceeded 0.80, confirming that item error variances were minimal and the items reliably capture their target latent dimensions.

9. Factor Analysis

The structural development of the Oncofertility Support Scale utilized a split-sample exploratory and confirmatory factor analysis design (EFA/CFA), following guidelines established by Fabrigar et al. (1999) and Costello and Osborne (2005).

Exploratory Factor Analysis (EFA)

The initial validation sample of 343 young breast cancer patients was randomly divided using computer-generated pseudorandomization. Subsample 1 (n = 123) was used for exploratory structural discovery. The Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy was 0.91, and Bartlett’s Test of Sphericity reached statistical significance (χ² = 1842.34, p < 0.001), indicating suitable correlation matrices for factor extraction. Principal Axis Factoring with oblique (Promax) rotation was selected, reflecting the theoretical expectation that sub-dimensions of supportive clinical care correlate in healthcare environments.

Factor retention was determined using parallel analysis, visual inspection of the scree plot, and the Kaiser-Guttman eigenvalue-greater-than-one rule. The initial item pool was refined by removing items with low primary factor loadings (< 0.45), prominent cross-loadings (> 0.35 on secondary axes), or communalities below 0.40. The resulting clean 19-item structure converged into four distinct factors that collectively accounted for 75.8% of the total variance, exceeding the standard 60% threshold in social science instrument development.

Confirmatory Factor Analysis (CFA)

The refined four-factor structure was tested on Subsample 2 (n = 220) using Confirmatory Factor Analysis with Maximum Likelihood Robust (MLR) estimation, which provides standard errors and test statistics robust to non-normal distributions. The four-factor measurement model demonstrated acceptable goodness-of-fit to the empirical data:

• Comparative Fit Index (CFI): 0.914 (exceeding the standard 0.90 acceptable threshold).
• Root Mean Square Error of Approximation (RMSEA): 0.079 (90% Confidence Interval: 0.065–0.092, satisfying the ≤ 0.08 benchmark for acceptable fit).
• Standardized Root Mean Square Residual (SRMR): 0.058 (well below the 0.08 threshold).

All standardized factor loadings for the 19 individual items on their respective latent constructs were statistically significant (p < 0.001), ranging from 0.68 to 0.89.

Measurement Invariance

To ensure that the OSS measures the same psychological construct consistently across diverse demographic groups, the developers conducted multigroup confirmatory factor analysis (MG-CFA) testing for measurement invariance across patient age groups (< 35 years vs. ≥ 35 years) and baseline reproductive desires (desiring future children vs. undecided/not desiring future children). Across hierarchical levels of invariance testing—configural, metric (weak), and scalar (strong)—model fit changes met Cheung and Rensvold’s criteria (ΔCFI ≤ 0.010 and ΔRMSEA ≤ 0.015). These results confirm that differences in OSS scores across age and reproductive preferences reflect true differences in perceived support rather than psychometric measurement bias.

10. Instrument / Measurement Tool

The Oncofertility Support Scale is a patient-reported outcome measure administered in clinical or research settings:

• Test Type: Standardized Patient-Reported Outcome Measure (PROM); psychological self-report questionnaire.
• Target Population: Reproductive-aged female cancer patients (specifically validated in breast cancer patients aged 18 to 45 years undergoing or following antineoplastic treatment).
• Format: 19 structured items distributed across four clinical subscales.
• Administration Modality: Self-administered; accessible via paper-and-pencil questionnaires or secure digital/online survey platforms. Completion time ranges from 5 to 8 minutes.
• Language: Originally developed and validated in Chinese. English translation, validation, and cross-cultural adaptations are actively expanding across clinical oncofertility registries.
• Subscale Breakdown:
  • Information Support on Fertility Impact: Items 1, 2, 3, 4 (4 items)
  • Information Support on Fertility Preservation: Items 5, 6, 7 (3 items)
  • Fertility and Sexual Guidance: Items 9, 10, 11, 12 (4 items)
  • Fertility Communication and Supportive Networks: Items 15, 16, 17, 18, 19, 20, 21, 22 (8 items)
• Response Format: Standardized multi-point rating options evaluating perceived frequency, adequacy, and quality of support received across oncofertility dimensions.
• Scoring Rules: Subscale scores are derived by calculating the mean or sum of completed items within each respective domain. An overall total score can be calculated by aggregating all 19 items. Higher scores reflect greater perceived oncofertility support, broader access to clinical reproductive information, and more comprehensive communication networks. In research and quality-of-care audits, subscale scores are typically evaluated independently to identify specific institutional care deficits.

11. Permissions & Fee and Test Year

The Oncofertility Support Scale was formally introduced to the literature in 2025 through research conducted at the School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, and published in Supportive Care in Cancer (https://doi.org/10.1007/s00520-025-10250-0).

Licensing and Academic Accessibility: The scale is proprietary and protected by international copyright laws under the original researchers and academic publishers. It is made accessible for academic, non-commercial research, institutional quality-improvement audits, and educational pursuits upon obtaining formal permission from the corresponding author, Dr. Edmond Pui Hang Choi ([email protected]), or via direct request through institutional platforms at The University of Hong Kong. Commercial utilization, integration into proprietary digital health applications, or use within industry-sponsored pharmaceutical clinical trials requires formal written authorization and licensing agreements with the copyright holders. No unauthorized commercial reproduction, redistribution, or modification is permitted.

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13. Items of the Scale