Questionnaire Choice for Cancer Data Quality

Recruiting in Palo Alto (17 mi)

+74 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Recurrence, Second primary cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Choice PRO vs Fixed PRO for cancer patients?

The research highlights the importance of patient-reported outcomes (PROs) in understanding treatment effectiveness, especially when data is missing. While specific data on Choice PRO vs Fixed PRO is not provided, the use of generalized estimating equations (GEEs) to handle missing PRO data suggests a robust method for evaluating treatment effectiveness in cancer trials. ^{1 2 3 4 5}

What safety data exists for the treatment evaluated under different names, including Choice PRO vs Fixed PRO, for various conditions?

The use of administrative data can help identify chemotherapy side effects, which are important for understanding the safety of cancer treatments. However, there are limitations in using such data, as it may not always accurately capture all clinical events. ^{5 6 7 8 9}

Is the treatment in the trial 'Questionnaire Choice for Cancer Data Quality' a promising treatment?

The trial focuses on improving the quality of data collected through questionnaires for cancer research, which is important for understanding and treating cancer better. However, it does not involve a specific treatment or drug for cancer itself. ^{10 11 12 13 14}

Research Team

John M Salsman, PhD

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Choice PRO vs Fixed PRO (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mercy Cancer Center - Carmichael Carmichael, CA

Saint Joseph Radiation Oncology Resource Center Lexington, KY

McFarland Clinic PC-Trinity Cancer Center Fort Dodge, IA

Wake Forest School of Medicine Winston-Salem, NC

More Trial Locations

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Patients Recruited

153,000+

Findings from Research

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]

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]

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 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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Planning and reporting of quality-of-life outcomes in cancer trials. [2022]

2. England 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]

3. England pubmed.ncbi.nlm.nih.gov

Using generalized estimating equations and extensions in randomized trials with missing longitudinal patient reported outcome data. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Value of Progression-Free Survival in Metastatic Breast Cancer: Results From a Survey of Patients and Providers. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Can Oncology Practice Claims Data Replace Physician Reporting to State Cancer Registries? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Choice of imputation method for missing metastatic status affected estimates of metastatic prostate cancer incidence. [2023]

7. France pubmed.ncbi.nlm.nih.gov

The value of a health insurance database to conduct pharmacoepidemiological studies in oncology. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Validity of state cancer registry treatment information for adolescent and young adult women. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Can administrative data be used to measure chemotherapy side effects? [2015]

10. England pubmed.ncbi.nlm.nih.gov

Quality of cancer registry data: a comparison of data provided by clinicians with those of registration personnel. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A comparison of data quality and practicality of online versus postal questionnaires in a sample of testicular cancer survivors. [2018]

13. United States 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. [2019]

14. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Quality of the information obtained by a questionnaire survey in studying the epidemiology of malignant neoplasms]. [2016]