Real-world behavioral practices of cancer patients: time to shift from health related-QoL to real-life-QoL

doi:10.21203/rs.3.rs-3402109/v1

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Real-world behavioral practices of cancer patients: time to shift from health related-QoL to real-life-QoL

https://doi.org/10.21203/rs.3.rs-3402109/v1

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Background

Health-related quality of life (HR-QoL) is an assessments tool commonly used as an endpoint in clinical trials. While it evaluates the presence of various symptoms, it does not measure patients’ ability to maintain normal daily activities during cancer therapy. We designed a real-life quality of life (RL-QoL) tool, validated among a cohort of actively treated cancer patients at a single cancer center prior to the COVID-19 pandemic. Using this tool we discovered that most patients reported compromised daily activities. In this study we aimed to examine RL-QoL in an international cohort of patients.

Methods

A locally validated questionnaire was distributed internationally using the Belong.life digital health platform. We examined real-world patient reported practices, provided by patients voluntarily and anonymously. The survey consisted of demographic, clinical, behavioral parameters and sources guiding and supporting patient practices. Independent clinical and demographic variables were analyzed, and a multivariate logistic regression was performed identifying factors predicting restrictive behavior.

Results

The study comprised 1,395 patient reported outcomes. Most respondents were from the United Stated (1142, 78.43%), 225 (15.45%) from Israel, and a minority (89, 6.11%) from other countries. The majority of participants (1,005, 72.88%) reported at least one adopted limitation in daily activities, and 305 (21.86%) maintained more than half of these constraints. Daily life restrictions included avoiding sun exposure (779, 57.83%), international travel (417, 33.33%), indoor public places (431, 33.13%), hair dyeing (271, 22.72%), domestic tourism (284, 21.93%), contact with friends and family (231, 17.69%), children and grandchildren (202, 16.33%), outdoor public spaces (190, 14.62%), and contact with pets (135, 10.41%). Multiple sources were implicated by patients guiding their behavior, including health-care professionals (951, 65.95%), non-medical authorities including the internet, patient forums, partners, friends, and family (171, 11.86%), and both non-medical authorities and the health-care team (320, 22.19%).

There was no association between country of origin (p=0.118), and education level (p=0.3591) across patients who maintained strict (≥50% of the limitations) and less strict restrictions (<50% of the limitations). A significant association was noted between younger age (p=0.0014), female sex (p=0.0141) and primary cancer site (p<0.0001), and the adoption of strict restrictions.

Conclusion

The majority of patients globally reported compromised daily activities, which are likely attributed to misconceptions about therapy and disease. These findings call for the assessment of an overlooked measure, RL-QoL, as an additional endpoint of clinical trials, aiming to achieve the ultimate benefit for our patients, a measure of a full and meaningful life.

cancer

behavior

restrictions

health-related quality of life

patient reported outcomes

Cancer treatment often involves various therapies that can significantly impact patients’ quality of life (QoL). In recent years, there has been increasing recognition of the importance of health-related quality of life (HRQoL)^1,2 scales, which have become a standard endpoint of many clinical trials, and an independent predictor of survival in patients with cancer³. Patient-reported outcome measure (PROM)⁴ questionnaires are commonly used to analyse QoL. However, these tools focus primarily on specific health-related signs and symptoms, such as fatigue, nausea, and diarrhea, and do not fully reflect patients' maintenance of normal life, including the continuity of routine social interactions and daily activities.

Patients frequently adopt restrictions including diet, exercise, social interactions and environmental exposures, which interfere with normal daily life. Despite these challenges, most clinical trials and regulatory agencies have focused on evaluating the safety and efficacy measures of cancer treatments, rather than the impact on patients’ behavior and activity, real-life quality of life (RL-QoL). As a result, the medical community has traditionally limited its responsibility to the evaluation of treatment toxicities, and efficacy measures such as survival, time to disease progression, and treatment response, while somewhat neglecting its ultimate mission of improving QoL in its broader sense. Furthermore, misbeliefs about disease and treatment may also interfere with normal life, and their repercussions are not captured in HRQoL questionnaires.

We aimed to evaluate patients' real-life behavior and activity when receiving cancer treatments. Our study was designed to assess the impact of cancer treatments on patients' daily lives and address the need for a more comprehensive approach to cancer care beyond safety and efficacy of treatments, aiming to address their impact on patients' QoL in its wider sense.

Addressing this gap, we developed a real-life quality of life (RL-QoL) tool, validated among a cohort of actively treated Israeli cancer patients in a single tertiary cancer center before the COVID-19 pandemic. We performed a locally validated questionnaire among 208 patients treated with solid tumors at the Tel-Aviv Sourasky Oncology Division⁵. The locally validated study demonstrated the surprising findings, that most cancer patients reported compromised daily activities, which are likely attributed to misbeliefs about disease and treatment. The majority reported at least one social-environmental avoidance or dietary limitation (136, 65% and 120, 57.7%, respectively), including abstaining from social contact, avoiding pets, public domains, traveling and maintaining dietary constraints. Adoption of these measures was not associated with clinical, demographic factors and treatment type. The major sources guiding restrictions came from advice of non-medical personnel (55.7%), the internet (7.2%) and personal choice by the patients themselves (24%). Using this tool, we discovered that most patients reported compromised daily activities, thus impacting QoL, in its wider sense, namely, the ability to conduct a full and meaningful life.

In this current study, we aimed to evaluate RL-QoL, among a broader patient population, across borders, and cultures including patients treated with haematological malignancies, in hopes of better identifying if the results of our locally validated study, stem from a global underestimation of cancer patients misguided real-life daily practices.

Study objectives

The questionnaire was developed and locally validated prior to the COVID-19 pandemic, to assess real-life behavior and activity of actively treated cancer patients at a single tertiary cancer center. This study’s questionnaire was distributed to patients using the Belong.life digital social and professional platform, provided anonymously and voluntarily through a free globally accessible digital platform for cancer patients and their caregivers. The survey assessed various social, and environmental abstentions adopted by patients, beyond the standard assessment of HRQoL. Moreover, it aimed to evaluate sources endorsing patient practices and misbeliefs guiding patients. Additionally, we sought to understand the potential clinical and demographic factors associated with restrictions and identify a population with more and less restrictive behavior patterns.

Study design

We conducted a cross-sectional anonymous survey, completed by patients from August 2022 -September 2022. The study population included adult patients using the Belong.life digital platform and treated with solid tumors and hematological malignancies (> 18 years old) receiving active antineoplastic treatment. Excluded were patients under 18 years of age, treated with best supportive care or under observation without active cancer therapy. The study was approved by the local research Helsinki ethics board (TASMC Helsinki Review Board Approval number TLV-0752-22).

Characteristics of the survey

We reviewed the standard validated HRQoL questionnaires^3,6,7 and understood that they did not address the misbeliefs associated with disease and treatments and its impact upon compromised daily activities as a measure of QoL. We searched alternative sources guiding patient behavior such as cancer association^8–10 and online forum recommendations. The original survey was developed by the investigators and was validated and implemented at a tertiary care cancer centre among 208 respondents before dissemination in the Belong.life digital platform. The items selected were based on common social, and environmental abstentions endorsed by various esteemed cancer organizations, deemed to be an essential part of daily activity and adjusted to variables unique to a broader patient population. The questionnaire consisted of fifteen questions, including demographic, clinical, behavioral parameters and sources guiding and supporting patient practices. Independent clinical and demographic variables were analyzed. The survey was available in English and Hebrew (Supplementary data).

Statistical analysis

Independent demographic (sex, age, country of origin, and education level) and clinical (primary cancer diagnosis) variables were characterized by appropriate descriptive measures. A scoring system was developed for analysis, in which each question received a score of 1 for restricted, and 0 for never restricted, thus creating a summary variable restriction score for social-environmental measures. The relationship between demographic and clinical characteristics of patients and the general restriction score (receive a value 1 for strict restricted patients and a value 0 for less restricted) and was assessed using a χ2 test.

Multivariate logistic regression model was carried out to identify factors (demographic and clinical characteristics of patients) which predict restrictive behavior. Statistical analysis was completed with the SPSS 25 software. Statistical significance was set at P < 0.05, using two-tailed tests.

The study population comprised 1,395 patients receiving active cancer therapy (Table 1). The majority of respondents were over the age of 40 (1,362, 93.54%), females (1022, 70.33%), with a higher education (937, 64.35%), from the United States (1142, 78.43%), while 225 (15.45%) respondents were from Israel, and only a minority (89, 6.11%) from other countries. The most common tumor types included breast (28.37%), gastrointestinal (204 ,14.01%), genitourinary (177, 12.16%), gynecological (188, 12.91%), lung (164, 11.26%), hematological (171, 11.74%), and other malignancies (139, 9.55%).

Table 1

Demographic and clinical characteristics of the study population
N = 1395, n (%)
Age, years
< 40	94 (6.46)
40–60	592 (40.66)
> 60	770 (52.88)
Sex
Female	1022 (70.33)
Male	431 (29.66)
Country
Israel	225 (15.45)
United States	1142 (78.43)
Other	89 (6.11)
Education
Elementary/Middle/High school	519 (35.65)
Academic degree	937 (64.35)
Primary cancer diagnosis
Breast	413 (28.37)
Gastrointestinal	204 (14.01)
Genitourinary	177 (12.16)
Gynecological	188 (12.91)
Lung	164 (11.26)
Hematological	171 (11.74)
Other	139 (9.55)
Limitations adopted by oncology patients
Adopted any restriction ≥ 1 restrictions	1005 (72.88)
Strict: Adopted ≥ 50% of restrictions	305 (21.86)
Less Strict: Adopted < 50%	1090 (78.14)
Sources of information guiding practices
Health-care personnel	951 (65.95)
Other*	171 (11.86)
Both healthcare personnel and Other sources	320 (22.19)
Other* sources of information included internet, patient forums, partners, friends, and family.

The majority of participants (1005, 72.88%) reported on at least one adopted limitation in daily activities, while 305 (21.86%) maintained more than half of the restrictional practices (Fig. 1). Daily-life restrictions included avoiding sun exposure (779, 57.83%), international travel (417, 33.33%), indoor public places such as malls (431, 33.13%), hair dyeing (271, 22.72%), domestic tourism (284, 21.93%), contact with friends and family (231, 17.69%), children and grandchildren (202, 16.33%), outdoor public spaces (190, 14.62%), and contact with pets (135, 10.41%).

Multiple sources were implicated by patients which guided their behavior, with the most common being health-care professionals (951, 65.95%), non-medical authorities, including the internet, patient forums, partners, friends, and family (171, 11.86%), followed by both non-medical authorities and health-care team (320, 22.19%, Fig. 2).

In an effort to identify demographic and clinical parameters associated with stricter behavior, patients who maintained ≥ 50% of the restrictions (305, 21.86%) were compared to those maintaining < 50% of the practices (1,090, 78.14%, Table 2). Patient country of origin and education level were not associated with the degree of restrictions maintained (p = 0.12, and p = 0.36, respectively). A significant association was noted between younger age (p = 0.001), female sex (p = 0.01) and primary cancer site (p < 0.0001), and the adoption of strict restrictions.

Table 2

Strict and less strict restrictional behavior of actively treated patients with cancer
N = 1395, n (%)
	Strict restrictional behavior^a n = 305 (21.86)	Less strict restrictional behavior^b n = 1090 (78.14)	P value^c	Pearson Chi- Square^d
Age group, years			0.0014	13.102
< 40	32 (37.21)	54 (62.79)
40–60	125 (21.74)	450 (78.26)
> 60	148 (20.16)	586 (79.84)
Sex			0.0141	6.0197
Female	232 (23.51)	755 (76.49)
Male	71 (17.53)	334 (84.47)
County of origin			0.1184	4.2679
United States	240 (22.14)	844 (77.86)
Israel	40 (17.94)	183 (82.06)
Other	25 (28.41)	63 (71.59)
Education			0.3591	0.8411
Middle/High school	115 (23.23)	380 (76.77)
Academic degree	190 (21.11)	710 (78.89)
Primary cancer diagnosis			< 0.001	59.1301
Breast	90 (22.84)	304 (77.16)
Gastrointestinal	42 (21.11)	157 (78.89)
Genitourinary	14 (8.48)	151 (91.52)
Gynecological	36 (19.78)	146 (80.22)
Lung	29 (18.24)	130 (81.76)
Hematological	69 (42.07)	95 (57.93)
Other	25 (18.94)	107 (81.06)
Sources of information guiding practices			0.0091	9.2895
Health-care personnel	184 (20.13)	730 (79.87)
Other*	30 (19.61)	123 (80.39)
Both healthcare personnel and other sources	89 (28.16)	227 (71.84)
^aStrict restrictional behavior patients maintaining ≥ 50% of restrictions.
^bLess strict maintenance of limitations includes patients who kept < 0.05,
^cStatistical significance was set at P < 0.05, using two-tailed tests
^dStatistical test- the variables were assessed using a χ² test
*Other- sources of information included internet, patient forums, partners, friends, and family.

Multivariate logistic regression was carried out to identify factors associated with strict restrictional behavior. Demographic factors including country of birth (P = 0.76) and education (p-value = 0.37) were not associated with patient practices. Patient age was an independent variable associated with strict behavioral practices (P = 0.04). A trend was seen among younger patients, those under age of 40, were 2 times more likely to maintain strict practices than the cohort aged 40–60 (OR = 2.05, p = 0.05, CI=(1.15,3.66)). There was no significant difference in behavior between the young subjects, under age 40, and those older than 60 (p = 0.06). Both ends of the age spectrum were more stringent in maintaining restrictional practices. Patient primary cancer diagnosis was significantly associated with strict restrictive behavior (P < 0.0019). Patients with haematological malignancies maintained nearly 2 times higher stricter practices than among subjects with solid tumors, (OR = 2.16, p = 0.025, CI=(1.1,4.24)).

Sources of information guiding patients were influential, impacting patient decisions and practices (P = 0.02). Patients provided sources of guidance from both health-care professional and other sources (including the internet, patient forums, friends and family) were 50% more likely to maintain strict restrictions than among subjects who only received information from health-care professionals (OR = 1.53, P = 0.007, CI = 1.08,1.16)). While patients who received guidance from both health-care professional and other sources were 90% more likely to maintain strict restrictions than among subjects who only received information from other sources (OR = 1.89, p = 0.026, CI = 1.09,3.31)).

Among the respondents, 104 (9.33%) affirmed that the restrictions in daily practices throughout cancer therapy were very difficult, 281 (25.2%) expressed moderate difficulty, while 730 (65.47%) patients stated that the restrictions were not difficult to maintain.

This work demonstrated that the majority of patients globally reported compromised daily activities, which are likely attributed to misconceptions about therapy and disease, deleteriously impacting RL-QoL.The health-care community has traditionally limited its responsibility to the evaluation of treatment toxicities and efficacy measures by assessing HRQoL, while not capturing the ultimate measure of QoL in its broader sense, real life daily practices of cancer patients by accounting for RL-QoL. Misbeliefs about disease and treatment most likely are the principle stimulus of misinformation.

We present the results of our study, which aimed to identify the prevalence of restrictive behavioral measures by cancer patients and their impact on RL-QoL. Our findings suggest that the majority of patients (72.88%) adopt restrictive behavioral measures, while one-fifth (21.86%) maintain strict abstentions of daily practices, which likely has a detrimental impact on QoL. These findings highlight the importance of considering patients' real-life behavior and activity when evaluating cancer treatments and developing practical supportive care strategies.

Patients affirmed that they avoided holding their children, and grandchildren, visiting friends and family, refrained from travel, and contact with pets. This work provided valuable insight into the impact of cancer treatments on patients' daily lives and emphasizing the need for a more comprehensive approach to cancer care that addresses better patient and health-care team education.

Younger patients maintained stricter behavioral practices during active cancer therapy, possibly reflecting a greater proportion of patients with haematological diseases, a population often treated with bone marrow transplants and highly myelosuppressive regimens. These patients have deeper and longer durations of neutropenia, associated with protocols with higher myelotoxic potential¹¹, possibly accounting for the strict daily practices adopted by this patient population.

Interestingly more than two-thirds of patients were misguided by health-care professionals, reaffirming the need for clear guidelines. Misbeliefs can often lead to patient fear, which may in turn propagate patient adoption of restrictions. The study findings underscore the importance of providing evidence-based recommendations to cancer patients regarding their daily activities. By providing reliable information, dispelling myths and unnecessary restrictive measures, healthcare providers can help to alleviate some of the anxiety and stress associated with cancer, and support patients in maintaining a sense of normalcy in their daily lives.

There are several potential limitations to the current study; it was conducted using a global digitalized platform Belong.life, which may limit the generalizability of the findings to the select population with access to the application, likely underrepresenting an elderly population with less digital proficiency. Therefore, caution should be taken in generalizing the findings to other populations. Additionally, the majority of the respondents were from the United States, and only a minority from other countries. Moreover, the survey was conducted among patients with various cancers and treatments, which could limit the ability to analyse the specific effect of each of these parameters on daily activity, and lastly, the questionnaire requires further validation and refinement in a prospective randomized clinical trial.

The current approach to assessing HRQoL in cancer patients should be re-evaluated to include a broader range of daily activities that better captures the unique challenges faced by cancer patients, providing a more holistic understanding of their RL-QoL.

We developed a survey evaluating RL-QoL, a measure which is reflective of the entirely of a patient’s well-being, the maintenance of daily social and environmental activities which make us human. We initially revealed compromised daily activities of patients RL-QoL at a single cancer centre prior to the COVID-19 pandemic, and validated these findings within a broader, larger patient population; shedding light on a globally neglected measure. We developed tools to better examine RL-QoL, and call for the integration and implementation of these valuable measures, assessing real-life behavior and activity as an additional endpoint in future studies and in clinical practice.

Ethical Approval

The study was approved by the local research Helsinki Ethics committee board (TASMC Helsinki Review Board Approval number TLV-0752-22). The survey was completed by patients voluntarily and anonymously.

Funding

N/A

Availability of data and materials

The data that support the findings of this study are available from the corresponding author, ES, upon reasonable request.

Conflict of interest:

none

Financial Disclosure:

none

Healthy Days Methods and Measures | HRQOL | CDC. Published November 5, 2018. Accessed March 10, 2023. https://www.cdc.gov/hrqol/methods.htm
Osoba D. Health-related quality of life and cancer clinical trials. Ther Adv Med Oncol. 2011;3(2):57-71. doi:10.1177/1758834010395342
Quinten C, Coens C, Mauer M, et al. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009;10(9):865-871. doi:10.1016/S1470-2045(09)70200-1
Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016;13(5):319-325. doi:10.1038/nrclinonc.2015.222
Shachar E, Hasson SP, Ferro L, et al. Real-life daily activity: the impact of misbeliefs on quality of life among cancer patients. ESMO Open. 2022;7(3):100498. doi:10.1016/j.esmoop.2022.100498
Scott NW, Fayers P, Aaronson NK, et al. EORTC QLQ-C30 Reference Values Manual. Published online July 2008. Accessed January 24, 2022. https://abdn.pure.elsevier.com/en/publications/eortc-qlq-c30-reference-values-manual
Fitzsimmons D, Wheelwright S. Developing Cancer Quality of Life Assessment Tools. In: Kassianos AP, ed. Handbook of Quality of Life in Cancer. Springer International Publishing; 2022:39-60. doi:10.1007/978-3-030-84702-9_4
American Cancer Society | Information and Resources about for Cancer: Breast, Colon, Lung, Prostate, Skin. Accessed March 4, 2023. https://www.cancer.org/
Cancer Research UK. Cancer Research UK. Accessed March 4, 2023. https://www.cancerresearchuk.org/home
The Israel Cancer Association. The Israel Cancer Association. Accessed March 4, 2023. http://en.cancer.org.il
Kurtin S. Myeloid Toxicity of Cancer Treatment. J Adv Pract Oncol. 2012;3(4):209-224.

No competing interests reported.

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Real-world behavioral practices of cancer patients: time to shift from health related-QoL to real-life-QoL

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Abstract

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Introduction

Methods

Study objectives

Study design

Characteristics of the survey

Statistical analysis

Results

Discussion

Declarations

References

Additional Declarations

Supplementary Files

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