Utilization of an Electronic Patient-Reported Outcome Platform to Evaluate the Psychosocial and Quality-of-Life Experience Among a Community Sample of Ovarian Cancer Survivors

PURPOSE

Novel distress screening approaches using electronic patient-reported outcome (ePRO) measurements are critical for the provision of comprehensive quality community cancer care. Using an ePRO platform, the prevalence of psychosocial factors (distress, post-traumatic growth, resilience, and financial stress) affecting quality of life in ovarian cancer survivors (OCSs) was examined.

METHODS

A cross-sectional OCS sample from the National Ovarian Cancer Coalition-Illinois Chapter completed web-based clinical, sociodemographic, and psychosocial assessment using well-validated measures: Hospital Anxiety/Depression Scale-anxiety/depression, Post-traumatic Growth Inventory, Brief Resilience Scale, comprehensive score for financial toxicity, and Functional Assessment of Cancer Therapy-Ovarian (FACT-O/health-related quality of life [HRQOL]). Correlational analyses between variables were conducted.

RESULTS

Fifty-eight percent (174 of 300) of OCS completed virtual assessment: median age 59 (range 32-83) years, 94.2% White, 60.3% married/in domestic partnership, 59.6% stage III-IV, 48.8% employed full-time/part-time, 55.2% had college/postgraduate education, 71.9% completed primary treatment, and median disease duration 6 (range < 1-34) years. On average, OCS endorsed normal levels of anxiety (mean ± standard deviation = 6.9 ± 3.8), depression (4.1 ± 3.6), mild total distress (10.9 ± 8.9), high post-traumatic growth (72.6 ± 21.5), normal resilience (3.7 ± 0.72), good FACT-O-HRQOL (112.6 ± 22.8), and mild financial stress (26 ± 10). Poor FACT-O emotional well-being was associated with greater participant distress (P < .001). Partial correlational analyses revealed negative correlations between FACT-O-HRQOL and anxiety (r = –0.65, P < .001), depression (r = –0.76, P < .001), and total distress (r = –0.92, P < .001). Yet, high FACT-O-HRQOL was positively correlated with post-traumatic coping (r = 0.27; P = .006) and resilience (r = 0.63; P < .001).

CONCLUSION

ePRO assessment is feasible for identification of unique psychosocial factors, for example, financial toxicity and resilience, affecting HRQOL for OCS. Future investigation should explore large-scale, longitudinal ePRO assessment of the OCS psychosocial experience using innovative measures and community-based advocacy populations.

INTRODUCTION

Psychosocial distress screening using innovative patient-reported outcome measurements is vital for the provision of comprehensive, patient-centered, value-based quality cancer care. For over 2 decades, the cancer community has devoted extensive efforts to the implementation of patient-reported outcome measures (eg, distress screens, symptom scales, and health-related quality of life [HRQOL]) during both routine cancer care and clinical trials to address distress, anxiety, depression, and physical symptom burdens to aid in critical care decisions to ultimately optimize cancer care delivery.^1,2 Despite these efforts, challenges exist for routine implementation of optimal psychosocial patient-reported outcome (PRO) assessment required for patient distress management and receipt of services.^3-7 For example, busy community oncology practices often miss symptom burdens as they tend to lack resources including staff trained to conduct such psychosocial PRO assessments and provide follow-up care as needed.^6-8 Recent empirical evidence examining symptom assessment conducted during chemotherapy via web-based, electronic PROs (ePROs) platforms has demonstrated great improvement in HRQOL with positive impacts on survival due in part to this early detection.^9,10 Yet, ePRO adoption remains limited for many oncology practices serving patient and survivor populations who experience symptom burdens, with significant distress desiring support, such as the ovarian cancer survivor (OCS).

CONTEXT

• Key Objective

• The psychosocial burdens that adversely affect health-related quality of life (HRQOL) for ovarian cancer survivors (OCSs) remain unknown. We sought to identify these psychosocial factors (anxiety, depression, post-traumatic coping, resilience, and financial distress) and HRQOL for OCS from the National Ovarian Cancer Coalition-Illinois Chapter.

• Knowledge Generated

• Using virtual electronic patient-reported outcome (PRO) platform technology to assess psychosocial factors and HRQOL, it was determined that OCS experienced mild distress and financial stress. Although they reported overall good HRQOL, emotional and functional well-being was poor. In addition, HRQOL was negatively correlated with PROs anxiety, depression, and total distress. Yet, for some OCS, HRQOL was positively correlated with post-traumatic coping and resilience.

• Relevance

• Assessment of psychosocial distress during survivorship is vital to follow long-term OCS HRQOL and inform psychosocial interventions to enhance PROs and overall coping.

In 2022, approximately 19,880 new cases of ovarian cancer are expected to be diagnosed with an estimated 12,810 deaths.¹¹ An ovarian cancer diagnosis is a life-threatening traumatic event, which deeply affects the individual's psychological well-being, leading to significant distress and lasting well into survivorship.^12,13 Intensive treatment, involving aggressive surgery, chemotherapy, and radiation, coupled with fears associated with ambiguity over disease recurrence, compromises overall HRQOL.^12-15 In fact, previous research indicates that across the cancer trajectory (eg, diagnosis, active treatment, and post-treatment in long-term survivorship), OCS desire sustained psychosocial, emotional, financial, and informational support to effectively cope with distress related to disease status and foster growth and resilience in the face of a traumatic experience.^12-15 Therefore, effective assessment of the OCS psychosocial and HRQOL experience is vital for the delivery of high-quality cancer survivorship care in a time of ambiguity.

The present study sought to digitally assess specific, key psychosocial factors (psychological well-being, posttraumatic coping, resilience, and financial distress) on overall HRQOL for OCSs who share membership in a Midwestern state–wide advocacy organization, the National Ovarian Cancer Coalition-Illinois (NOCC) Chapter. The primary study aim was to identify the prevalence of these psychosocial factors via ePRO platform technology to determine correlations with HRQOL while exploring other sociodemographic-clinical aspects.

METHODS

Procedure

Institutional Review Board approval was obtained before study initiation. A cross-sectional study was conducted via a single-event, confidential, anonymous virtual survey for NOCC members invited by e-mail notification for study participation. This e-mail contained a brief description of the study purpose, consent, and confidentiality. A subsequent e-mail was sent with an anonymous survey link for interested OCS participant completion via utilization of mobile phones, tablets, or internet. E-mail notifications were sent every 4 weeks. Responses were recorded in a confidential, password-protected database.

Participants

NOCC participant eligibility included self-reported age ≥ 18 years and primary stage I-IV ovarian cancer diagnosis living in Illinois. Patients who (1) were newly diagnosed (acute survivorship); (2) had completed initial surgery and treatment planning; (3) had initiated chemotherapy or radiation therapy; and (4) had treatment in late, long-term survivorship phases (≥ 4 years; extended/permanent) were eligible to participate.

ePRO Platform

The web-based, single-event 20-minute psychosocial ePRO assessment was empirically developed by primary investigators. Sociodemographic information (eg, age, ethnicity, and education) coupled with brief well-validated, widely accepted psychosocial measures assessing psychological distress/well-being (Hospital Anxiety and Depression Scale-anxiety/depression [HADS-A/D]/total),^16-19 post-traumatic growth (Post-traumatic Growth Inventory),^13,14 resilience (Brief Resilience Scale),^7,20 financial distress (comprehensive score for financial toxicity [COST]),^21-23 and HRQOL (Functional Assessment of Cancer Therapy-Ovarian [FACT-O])²⁴ was all digitized to capture participant responses. Participants accessed and completed this assessment via an anonymous survey link suitable for computers, cellular phones, or tablets. Each virtual page contained seven questions in a 12-point bold font to enhance comprehension and item response. After ePRO completion, responses were electronically scored. NOCC-IL staff provided referral information for psychological support program: Teal Comfort for the Mind.

Measures

Sociodemographics.

Participants self-reported age, ethnicity, education, employment, income, and marital status. Clinical characteristics obtained included diagnosis/stage, diagnosis duration, and treatment status.

Hospital Anxiety and Depression Scale.

Fourteen-item distress scale that includes two subscales: (1) seven items measure anxiety (eg, “Worrying thoughts go through my mind”) and (2) seven items measure depression (eg, “I feel cheerful”).^16-19 Responses are scored from 0 to 3, with subscale total scores ranging from 0 to 21. Caseness is defined according to these ranges for subscales: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. For total score, the HADS cutoff score of ≥ 15 is indicative of clinically significant distress.^13-15

Post-Traumatic Growth Inventory.

21-item measure assessing participant ability to find meaning after a traumatic cancer experience across five subscales (eg, Personal Strength) on a six-point Likert scale (0 = I did not experience this change to 5 = I experienced this change to great degree).^13,14 Post-traumatic coping scores range from 0 to 105, and high scores indicate greater change. Scores < 45 denote none to low growth; scores ≥ 46 denote moderate to high.

Brief Resilience Scale.

Six-item scale that assesses a positive response to adversities or recovery from a stressful experience.^7,20 Score ranges are from 1 (low resilience) to 5 (high resilience). Brief Resilience Scale scores are interpreted as follows: low 1.00-2.99, normal resilience 3.00-4.30, and high 4.31-5.00.

Comprehensive score for financial toxicity.

Eleven-item financial distress scale.^21-23 Scores range from 0 to 44, with lower scores indicating significant financial distress. Financial distress was defined < 26 and categorized into mild (14-25), moderate (1-13), and severe (COST 0).

Functional Assessment of Cancer Therapy-ovarian.

Thirty-nine–item multidimensional HRQOL questionnaire comprising the FACT-General measure (FACT-G) and 12-item ovarian cancer subscale.²⁴ Participants rate symptom expression within the past week on a five-point Likert scale (0 = not at all to 4 = very much). The Functional Assessment of Cancer Therapy-Ovarian (FACIT-O) yields the following: FACT-G, ovarian subscale, and FACIT-O-Total scores. Higher scores reveal better HRQOL.

Statistical Analyses

Data were coded and analyzed using standard STATA-17 statistical software by a statistician (K.E.W.).²⁵ The cross-sectional sample of N = 300 patients provided precise prevalence estimates on the basis of a binary variable, with the half width of a 95% CI being not larger than 6%. Descriptive statistics were calculated as relative frequencies for categorical data and mean/median and standard deviation for continuous variables. For psychosocial and HRQOL measures, scoring and subscale interpretation were based upon previous cancer-specific research.^13-24,26 To test associations between demographics and psychosocial measures, two-sample t-tests were performed. Pearson correlations explored the relationship between psychosocial factors and HRQOL. Partial correlation (adjusting for age, disease duration, body mass index [BMI], education, income, cancer stage, and treatment status) was performed to determine associations between HRQOL and psychosocial measures while eliminating the effect of the potential confounders (P < .05 was statistically significant).

RESULTS

A total of 174 of 300 participants (58% response rate) completed virtual psychosocial ePRO assessment. Table 1 presents sociodemographic characteristics including the following: median age 59 (range 32-83) years, 94.2% White, 60.3% married/in domestic partnership, 67.1% had children, 49.3% lived with a spouse/partner, 48.8% employed full-time/part-time, 55.2% had college/postgraduation education, 59.6% had stage III-IV cancer at diagnosis, 45% had recurrence, 71.9% were off-treatment, and a median disease duration of 6 (range < 1 to 34) years.

TABLE 1.

Demographic Characteristics of the Sampled NOCC OCSs

Table 2 shows OCS psychosocial characteristics. Participants scored in the normal range for anxiety (mean ± standard deviation: 6.9 ± 4.1) and depression (3.8 ± 3.6). Total HADS revealed that OCS experienced mild distress (10.9 ± 8.9). Post-traumatic coping was high (72.6 ± 21.5) with participants scoring within the normal level for resilience (3.7 ± 0.7). Although participants had good overall FACIT-O/HRQOL (112.6 ± 22.8), including the ovarian subscale (33.0 ± 6.2), they had low scores for emotional (17.5 ± 4.1) and functional (19.5 ± 6.4) well-being. COST indicated that OCS had mild financial distress (25 ± 10).

TABLE 2.

National Ovarian Cancer Coalition-Illinois Ovarian Cancer Survivors' Psychosocial Characteristics: Psychological Well-Being, PTG, Resilience, HRQOL, and Financial Distress

Correlations between the psychosocial variables and HRQOL are presented in Table 3.

TABLE 3.

Pearson and Partial Correlational Analyses for the Psychological Well-Being, Post-Traumatic Coping, Resilience, and Health-Related Quality of Life in OCSs

Pearson correlational analysis revealed a significant negative correlation between HADS-A anxiety and overall total FACT-O-HRQOL (r = –0.62; P < .001). This included all FACT-G (physical well-being [PWB], social well-being [SWB], emotional well-being [EWB], and functional well-being [FWB]) and the ovarian subscale domains. In addition, a significant negative correlation between HADS-D depression and FACT-O HRQOL was discovered (r = –0.82, P < .001). HADS-Total distress was also found to be negatively correlated with FACT-O/HRQOL (r = –0.52, P < .001). However, this correlational analysis also identified positive correlations between FACT-O-HRQOL and post-traumatic coping (r = 0.29, P < .001), resilience (r = 0.59, P < .001), and financial distress (r = 0.52, P < .001). The partial correlational analysis verified these findings (Table 3). FACT-O-HRQOL was negatively correlated with HADS-A-anxiety (r = –0.65, P < .001) including all domains (PWB, SWB, EMB, and FWB), HADS-D depression (r = –0.76, P < .001), and HADS-Total (r = –0.53, P < .001). Positive correlations between post-traumatic coping and FACIT-O-HRQOL (r = 0.27; P = .006) were highlighted in this analysis, including positive correlations between HRQOL and resilience (r = 0.63; P < .001) and financial distress (r = 0.48; P < .001; Table 3). From analyses, currently being in treatment was the covariate most consistently associated with HRQOL (those currently in treatment having worse HRQOL compared with those not in treatment) followed by BMI (higher BMI associated with worse HRQOL).

DISCUSSION

Previous research involving the OCS experience has primarily centered on the psychological challenges that survivors face.^2-5 However, to date, the potential positive psychosocial life changes that influence OCS overall HRQOL are yet to be reported. To our knowledge, this study is the first to assess the prevalence of unique psychosocial factors (psychological well-being, post-traumatic coping, resilience, and financial distress) and their impact on overall OCS HRQOL during survivorship, a time of ambiguity because of increasing fears of recurrence. Data were collected via ePRO assessment using an advocacy group to access a community population. To our knowledge, no other study has been conducted using this ePRO approach with this cancer survivor population. This study held several advantages by creating new approaches for psychological distress and HRQOL measurement outside of the busy stressful, clinical setting where accurate assessment remains challenging. Utilization of an ePRO platform enables OCS to complete assessment being in their home or office without scheduling formal clinical appointments. Furthermore, this research assessed a relatively untapped, ignored population for study.

Although OCS distress has been previously reported,^12,13 our participants did not endorse any significant depression or anxiety, and overall distress was found to be mild. This may be due to the phase of survivorship, as evidence suggests that those in the late, extended, survivorship stage experience mild distress, more resilience, elevated PTG, no financial distress, and enhanced HRQOL compared with early-stage OCS.^12-15 It may also be related to the selective nature of this cohort relative to who does (and can) access and become a NOCC member. Evidence indicated that early-stage OCSs desire psychosocial intervention,^12-15 and thus, future investigation should explore differences between survivorship groups on the basis of the disease phase. From a clinical perspective, it is anxiety, fear, and worry of recurrence that must be monitored over the course of survivorship. Our results are consistent with the long-term OCS experience that, despite the screening measure used, over time, anxiety increases in the presence of compromised physical well-being that paradoxically, ultimately, leads to growth. For example, research using the HADS revealed that OCS anxiety levels gradually increase over time, whereas depression remains low.^27-30 Liavaag speculated that anxiety arises as a response to perceptions of an impending threat over the future (ie, fear of recurrence) where depression results from perceptions of hopelessness.²⁷ It is possible that OCSs worry regarding relapse and disease course rises over time where the initial loss of self at initial cancer diagnosis has been cognitively and emotionally processed, leading to acceptance rather than depression. In a 200-OCS study, Stewart et al²⁸ discovered that lived experiences of OCS positively altered their worldview and social relationships, resulting in greater coping, resilience, and growth. Partial correlational analysis paints a clearer picture of this for our OCS cohort as PTG and resilience were positively correlated with HRQOL. A new perspective of greater meaning and ability to positively adapt, and thrive, when confronted with the trauma of an ovarian cancer diagnosis enhances HRQOL in the face of symptom burdens and a time of uncertainty. Still, the OCS experience may activate internal coping resources, resulting in a sense of efficacy and utility, facilitating benefit-seeking and competency to cope with survivorship challenges.

Several preliminary findings may hold long-term negative implications for OCS well-being if left unaddressed. OCS reported good FACT-O-HRQOL, yet experienced lower EWB and FWB compared with published FACT-G/subscale-referenced scores. SWB remained sustained, with comparative FACT-G scores. This aligns with evidence revealing that OCSs experience diminished EWB and FWB, yet increased social support serves as a protective buffer.³¹ Social support and resilience may be critical resources for improving HRQOL and should be incorporated into psychosocial interventions. Also, OCS experienced mild financial distress, which affected HRQOL. Routine financial distress monitoring to track severity during survivorship may reveal underlying contributors. Further explorative study is warranted, yet our research provides initial evidence on these distinct, understudied, psychosocial factors providing innovation with an advocacy/community-based population in the context of utilization of eHealth platforms to capture PROs and OCS experiences. OCSs remain under-represented in research, despite significant burdens and persistent, recurrent disease. Future investigation should center on serial psychosocial and HRQOL ePRO assessments using technology to facilitate data collection to inform virtual psychosocial (social support and financial navigation) interventions in partnerships with cancer advocacy organizations.^32-35

Research collaboration with advocacy groups offers insight into the OCS psychosocial needs. The study by Ponto et al³⁶ centered on predictors of adjustment, and growth in NOCC participants revealed that younger age, few years in a relationship, predicted better adjustment, whereas poor performance status and symptom distress were associated with poorer overall adjustment with recurrent ovarian cancer. The research by Lutgendorf et al²⁹ compared the psychosocial and HRQOL outcomes of the Ovarian Cancer Fund Alliance/Ovarian Cancer Research Fund Alliance members with those of survivors from five academic centers and a community sample. Key results revealed that outcomes for OCS from academic centers and Ovarian Cancer Research Fund Alliance were relatively good with mean scores equal to community samples. These advocacy groups are a specialized cohort who are healthier and have access/means to supportive care and computer technology that the general ovarian population, especially underserved, may not. Racial/ethnic disparities exist within the entirety of ovarian cancer research as many studies center on White OCS with limited information available for Black Americans or Latinos.^37-39 Fortunately, a call for research arose to investigate clinical, societal, biologic, and behavioral factors behind racial disparities in ovarian cancer survival.³⁷ New epidemiologic studies designed to reveal factors associated with racial disparities including a lack of access to cancer care are underway. They are vital to address the gaps in the community's knowledge of the prevalence of ovarian cancer and symptom burdens identified through PRO assessment research and provide critical information to tailor quality interventions to eliminate disparities.

Several limitations should be noted. First, our study centered on the psychosocial experience of OCS members from an advocacy/community-based coalition in a Midwestern state in the United States, who were older and White, with higher income status;²⁹ thus, these experiences may not be representative of the general OCS population within the community, nationally or internationally. Next, a significant selection bias exists given that only 58% of participants completed ePRO assessment. Still, this response rate is higher compared with published ePRO research in cancer (range: 32%-47%).^40-42 Random sampling, controlling selection-associated covariates, statistical correction, inverse probability weighting, and bias analysis may address selection bias. Consistent with research, participants with personal access to computer/tablet, phone, and technological skill were more likely to engage in virtual study participation.^40-42 Elderly, underserved/minority, or individuals with low technology literacy are less likely to participate.^40-42 Nevertheless, we obtained more than half of the total Illinois NOCC membership, maintaining statistical power, given the high-quality data obtained, which increased generalizability of results. A single-event, one-time ePRO psychosocial experience assessment was a limitation. Longitudinal ePRO assessment at targeted time points (treatment, post-treatment, and late survivorship) would reveal meaningful data for symptom identification and monitoring critical for OCS with recurrent disease or in late survivorship.^12,15 This would ensure greater reliability-validity of the ePRO platform via examination of correlations and use of a test-retest study by performing the same methods/measures, with identical respondents at different time points.^43,44 Next, a score-trigger system was not activated within the ePRO platform alerting staff for referral for elevated psychosocial distress because of limited psychosocial staff support. Also, despite our best efforts to obtain refuser demographic/disease information, we were unable to identify if nonrespondent symptoms were unique to respondents. Refusers may experience greater physical and emotional distress; however, this is only a hypothesis. These data would permit evaluation of self-selection bias to identify factors associated with increased likelihood of consent to internet-based PROS studies.^43,44 Finally, use of brief psychosocial measures via an online, ePRO platform may not adequately capture symptom severity. Evaluation of ePRO platform's reliability-validity using psychometric analysis determines that the degree measures yield the same score for each administration.⁴⁵ Internal consistency reliability delivers a reliability estimate for multidimensional/item scales to determine associations (eg, Cronbach coefficient alpha). Validity (content, criterion, and construct) is required via comparison with previously validated instruments measuring similar psychosocial and HRQOL domains/constructs. However, given robust psychometric properties, these measures detected the minimal level of existing symptom burden. Moreover, a report addressing best practices in oncology for distress management suggests that the community must move beyond sole consideration over the type of screening.³⁰ Rather, clinicians and researchers must center efforts on direct action of the information that the screening provides, that is, distress severity, to refer to and deliver equitable access to mental health services.^30,46,47

Assessment of psychosocial outcomes affecting overall HRQOL is a crucial resource for the multidisciplinary oncology team that aims to maximize HRQOL. Nevertheless, routine symptom assessment to track increasing severity is a challenge especially when targeting remote groups within the community in need of vital psychosocial support. Web-based, ePRO assessment conducted in partnership with advocacy groups is an optimal approach for identification of survivors with distress and symptom burden and serves as a referral resource for psychosocial support (eg, individual/group psychotherapy, contemplative awareness practices, and e-health interventions).⁴⁶ The demand for future studies centering on formal app technology development for routine symptom self-monitoring to provide real-time feedback for survivors with immediate scoring results and electronic triggers alerting the survivor symptom burdens is high warranting medical/psychological attention. Hence, the application of early, longitudinal web-based ePRO psychosocial assessment should be incorporated as an essential component in survivorship care.

In summary, ePRO psychosocial distress and HRQOL assessment is a vital tool to inform community partners and clinicians of unique symptom burdens, financial toxicity, or resilience, encountered by OCS. These approaches inform development of tailored interventions (eg, web-based peer/group support) critical to reach a remote proportion of community-based OCSs to enhance coping, to thrive, in the face of ambiguity.

AUTHOR CONTRIBUTIONS

Conception and design: Fay J. Hlubocky, Karen Young, Nita K. Lee

Financial support: Fay J. Hlubocky, Christopher K. Daugherty, Nita K. Lee

Administrative support: Fay J. Hlubocky, Christopher K. Daugherty, Nita K. Lee

Provision of study materials or patients: Fay J. Hlubocky, Karen Young, Nita K. Lee

Collection and assembly of data: Fay J. Hlubocky, Karen Young, Seiko Diane Yamada

Data analysis and interpretation: Fay J. Hlubocky, Christopher K. Daugherty, Jeffery Peppercorn, Kristen E. Wroblewski, Nita K. Lee

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/cci/author-center.

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