Questionnaire Choice for Cancer Data Quality

Recruiting at 74 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Recurrence, Second primary cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how young adults with cancer can best report their quality of life using different questionnaires. One group will use a fixed set of questions (Fixed PRO), while the other will select questions most relevant to them (Choice PRO). The researchers aim to determine which method patients find more feasible and acceptable. Suitable participants have received a cancer diagnosis within the last 12 weeks, are undergoing treatment, and are comfortable using technology to complete surveys in English. As an unphased trial, this study allows participants to contribute to enhancing quality of life assessments for future patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating questionnaires, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

What prior data suggests that this protocol is safe?

Research has shown that using Patient-Reported Outcomes (PROs) in cancer trials is generally safe. PROs are tools that gather information directly from patients about their symptoms or quality of life, helping researchers understand how a treatment affects daily life.

The study under consideration examines two methods of using PROs: Choice PRO and Fixed PRO. Both methods involve patients sharing their experiences, which is non-invasive and does not involve drugs or physical procedures. Consequently, there are no known safety concerns or side effects associated with using PROs.

In summary, participating in this trial and using either type of PRO should be safe, as it involves completing surveys about health experiences rather than taking new medication or undergoing a procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Questionnaire Choice for Cancer Data Quality trial because it explores how different methods of collecting patient-reported outcomes (PROs) might improve the quality of data in cancer care. Unlike traditional fixed PRO measures, which pre-select questions for patients, the Choice PRO allows patients to choose the domains most relevant to them. This personalized approach could lead to more accurate and meaningful data, reflecting the true impact of cancer and its treatment on patients' lives. By potentially enhancing the relevance and precision of health-related quality of life (HRQOL) data, this trial could pave the way for better-informed treatment decisions and patient care strategies.

What evidence suggests that this trial's treatments could be effective for cancer data quality?

Research has shown that using patient-reported outcomes (PROs) in cancer studies can help create better treatment guidelines. These PROs offer a clearer understanding of how treatments affect patients' daily lives. A core set of PRO measures leads to high-quality data about symptoms and patient functioning. This information aids in making decisions about cancer treatments. In this trial, participants will join either the Control arm, which uses five pre-selected HRQOL measures, or the Intervention arm, which uses five domain-specific HRQOL measures. Overall, these findings support the idea that both Choice PRO and Fixed PRO methods effectively capture important patient experiences during cancer treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

John M Salsman, PhD

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 with a recent diagnosis of various cancers like leukemia, breast cancer, or melanoma. They must be able to use text messaging, provide consent, and complete English questionnaires online. Those with cognitive impairments, recurrences or second primary cancers are excluded.

Inclusion Criteria

My cancer diagnosis was confirmed by a lab test within the last 12 weeks.

You are expected to live for more than 24 months.

Patient must be able to complete questionnaires in English

Exclusion Criteria

I do not have basal cell skin cancer.

I have not had cancer come back or developed a new type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including PROs

1 month

1 visit (in-person or virtual)

Intervention

Participants are randomized to Choice PRO or Fixed PRO and complete assessments at 1, 3, 6, and 12 months

12 months

4 visits (virtual)

Follow-up

Participants are monitored for preferences on PRO data sharing and utilization

up to 52 months

What Are the Treatments Tested in This Trial?

Interventions

• Choice PRO vs Fixed PRO

Trial Overview

The study tests how well adolescents and young adults can report their own health status using two different methods: Choice PRO where they choose what to report vs Fixed PRO where the topics are pre-selected. It checks which method is easier and more reliable for them.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

5 domain-specific HRQOL measures

Group II: Control arm Experimental Treatment 1 Intervention

5 pre-selected HRQOL measures

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Published Research Related to This Trial

An observational cohort study compared chemotherapy side effects reported in administrative data with those reported by patients, highlighting discrepancies between the two sources.

While administrative data offers easy access and generalizability for economic evaluations, it may not reliably capture all clinical events, raising concerns about its use in economic models for chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can administrative data be used to measure chemotherapy side effects? Pearce, A., Haas, M., Viney, R., et al.[2015]

The study assessed the accuracy of cancer registry data by comparing clinician-reported information with data collected by registration personnel, involving a sample of 190 cancer cases from 1989 and 1990.

Results showed a high level of agreement, with major disagreements at 0% for date of birth and gender, and only minor discrepancies for other data points, indicating that registration personnel can collect cancer data with high accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of cancer registry data: a comparison of data provided by clinicians with those of registration personnel. Schouten, LJ., Jager, JJ., van den Brandt, PA.[2019]

A survey of 299 metastatic breast cancer patients, along with 100 oncologists and 99 oncology nurses, revealed that nearly all patients preferred treatments that provided longer periods of progression-free survival (PFS), while oncologists and nurses showed less preference for PFS over overall survival (OS).

Despite a majority of patients valuing longer OS, only 15% of nurses preferred it, indicating that PFS may be a more relevant endpoint for patients, and highlighting the need for further research into why PFS is valued so highly by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Progression-Free Survival in Metastatic Breast Cancer: Results From a Survey of Patients and Providers. MacEwan, JP., Doctor, J., Mulligan, K., et al.[2020]

In a study of 173 cancer trials, only 52% included quality of life (QoL) outcomes in their protocols, highlighting a significant gap in addressing patient-centered concerns during cancer treatment.

Despite half of the trials specifying QoL outcomes, only 20% reported any QoL data in their publications, indicating that crucial information for patients and oncologists is often missing, which can hinder informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning and reporting of quality-of-life outcomes in cancer trials. Schandelmaier, S., Conen, K., von Elm, E., et al.[2022]

Generalized estimating equations (GEEs) are effective statistical methods for analyzing patient-reported outcomes (PROs) with missing data in randomized trials, as demonstrated in a study of cancer survivors with cognitive symptoms after chemotherapy.

The choice of analytical approach significantly affects the results, with odds ratios for cognitive impairment varying widely, highlighting the importance of using robust methods to ensure unbiased estimates in oncology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using generalized estimating equations and extensions in randomized trials with missing longitudinal patient reported outcome data. Bell, ML., Horton, NJ., Dhillon, HM., et al.[2022]

A significant 66% of cases in the clinical cancer register had missing M stage data, which varied by risk group and over time, highlighting the challenge of incomplete data in cancer registries.

Using a combination of deterministic imputation and multiple imputation methods allowed for more accurate estimates of metastatic prostate cancer incidence, producing survival curves that closely matched those of men with known M stage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of imputation method for missing metastatic status affected estimates of metastatic prostate cancer incidence. Westerberg, M., Beckmann, K., Gedeborg, R., et al.[2023]

The accuracy of cancer treatment information in the North Carolina Central Cancer Registry (CCR) was found to be high for chemotherapy (86% sensitivity) and moderate for radiation (74% sensitivity), based on a study of 2342 young women diagnosed with various cancers.

However, the registry data was less reliable for hormone therapy, particularly for breast cancer, with only 67% sensitivity and 70% positive predictive value, indicating that while CCR data is useful, it may not fully capture all treatment types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of state cancer registry treatment information for adolescent and young adult women. Anderson, C., Baggett, CD., Rao, C., et al.[2021]

The study assessed the coding completeness and reliability of Thailand's National Cancer Institute hospital-based cancer registry, finding an overall coding completeness of 89.9% for registered data and 93.6% for reabstracted data, indicating a high level of data quality.

The agreement rate among variables ranged from 84.7% to 99.6%, with a κ coefficient indicating strong reliability; however, issues like misclassification of laterality and sex in certain cancer cases highlight areas for improvement in data accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data Reliability and Coding Completeness of Cancer Registry Information Using Reabstracting Method in the National Cancer Institute: Thailand, 2012 to 2014. Sirirungreung, A., Buasom, R., Jiraphongsa, C., et al.[2019]

The reliability of data collected in a retrospective cohort breast cancer study in Estonia was found to be 83.4%, indicating a generally good consistency in responses from participants.

However, significant discrepancies were noted, as 2.5% of women with severe lung tuberculosis and 30.3% of milder cases denied their previous disease, highlighting the need for improved quality control in cancer epidemiology studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of the information obtained by a questionnaire survey in studying the epidemiology of malignant neoplasms]. Tekkel, MIu., Kolle, KhA.[2016]

In a study of 3 oncology practices reporting 3,224 cancer cases diagnosed in 2017, only 7.2% (233 cases) were reported solely by these practices, indicating that most cases were also captured by other sources or claims data.

While claims data covered nearly all reported cases, 2.1% of the tumors reported only by the practices were not captured in claims data, suggesting that completely relying on claims data could lead to missing important cancer information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Oncology Practice Claims Data Replace Physician Reporting to State Cancer Registries? Kuliszewski, MG., Lee, FF., Schymura, MJ.[2021]

The French national health insurance database (SNDS) is a valuable resource for studying the effectiveness and safety of anticancer drugs in real-world settings, providing extensive patient data and drug exposure information.

However, the database has limitations, including challenges in accurately identifying diseases and treatment details, which can affect the quality of research; thus, linking SNDS with cancer registries and using standardized methods are essential for improving study outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of a health insurance database to conduct pharmacoepidemiological studies in oncology. Conte, C., Vaysse, C., Bosco, P., et al.[2019]

The Prospective Dutch Colorectal Cancer (PLCRC) cohort, which has enrolled 5744 patients since 2013, is designed to collect real-world data and patient-reported outcomes to enhance clinical oncology research, showing a significant increase in enrollment over the years.

While the PLCRC cohort reflects the Dutch colorectal cancer population to some extent, it still shows imbalances in age and tumor stage compared to the general population, indicating ongoing efforts are needed to improve its representativeness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care. Derksen, JWG., Vink, GR., Elferink, MAG., et al.[2021]

Online questionnaires for cancer research resulted in significantly lower participant nonresponse rates compared to postal questionnaires, indicating better data quality.

Participants with higher education levels were more likely to choose online questionnaires, which could introduce sampling bias; however, online methods still provided a faster and more efficient way to collect high-quality data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of data quality and practicality of online versus postal questionnaires in a sample of testicular cancer survivors. Smith, AB., King, M., Butow, P., et al.[2018]

In a study involving 375 cancer patients receiving non-platinum-based chemotherapy, it was found that quality-of-life (QoL) data were not missing at random, which could lead to overly optimistic results if traditional analysis methods were used.

Despite the challenges posed by incomplete data, the treatment with epoetin alfa still showed significant QoL benefits compared to placebo, confirming its effectiveness even when accounting for the non-random missing data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of epoetin alfa for cancer patients' quality of life are confirmed after modelling to account for missing data. [2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11315859/

The Importance of Patient Reported Outcomes in Oncology ...

PROs data from cancer clinical trials can provide valuable evidence to inform shared decision-making, labelling claims, clinical guidelines, and ...

2.

withpower.com

withpower.com/trial/phase-sarcoma-9-2021-6697e

Questionnaire Choice for Cancer Data Quality

The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO. Show more. Do I need ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1470204525001500

Using patient-reported outcomes and health-related quality ...

Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop.

4.

fda.gov

fda.gov/media/149994/download

Core Patient-Reported Outcomes in Cancer Clinical Trials

Systematic assessment of a core set of PROs using fit-for-purpose5 PRO measures can facilitate high quality data on patient-reported symptoms and functional ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK_159514

Patient-Reported Outcomes in Cancer Clinical Trials

There has been a call to improve the quality of PRO data captured from cancer clinical trials and integrate more of these data in the FDA product label.

6.

friendsofcancerresearch.org

friendsofcancerresearch.org/publication/supporting-a-patient-centric-approach-to-dose-optimization-in-oncology-the-essential-role-of-patient-reported-outcomes-pros/

The Essential Role of Patient-Reported Outcomes (PROs)

PRO results should be considered in the context of other data to establish a totality of evidence alongside clinician reports of safety and efficacy, ...

7.

valueinhealthjournal.com

valueinhealthjournal.com/article/S1098-3015(21)01528-X/fulltext

Commercial Clinical Trial Data From Four Cancer Types

This article describes the completion rates for patient-reported outcome (PRO) data that were collected after clinical trial participants discontinued ...

8.

intuitionlabs.ai

intuitionlabs.ai/articles/pro-systems-clinical-trials

Patient-Reported Outcomes (PRO) Systems: A Clinical ...

Learn about Patient-Reported Outcomes (PRO) systems in clinical trials. This guide covers ePRO data collection, PROMs, FDA regulatory ...