Patient Feedback Surveys for Breast Cancer

Recruiting at 2 trial locations

Overseen By Sarah Tevis

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Male, Under 18, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

925 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sharing survey results with breast cancer patients can impact their care and satisfaction. Participants will complete surveys about their health and experiences, with some receiving graphical feedback on their responses. Researchers aim to determine if this feedback affects patients' engagement with care and communication with doctors. Women recently diagnosed with breast cancer who can complete surveys themselves are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to research that could enhance patient care and satisfaction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this research protocol is safe for breast cancer patients?

Research has shown that using Patient Reported Outcome Measures (PROMs) in cancer care is safe. PROMs are surveys where patients provide information about their health and well-being. Studies have found that these surveys can enhance the quality of life for cancer patients. They help doctors understand patients' experiences better and adjust treatments if necessary. No evidence suggests that completing these surveys causes harm. Overall, PROMs are well-tolerated and beneficial for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how patient feedback can improve breast cancer care. Unlike traditional treatments that focus solely on medical interventions, this approach uses Patient Reported Outcome Measure (PROM) surveys to actively involve patients in their own treatment journey. In the experimental group, patients receive their survey results in graphical form, which could enhance their understanding of their health and foster better communication with healthcare providers. This method aims to empower patients by making them active participants in their care, potentially leading to improved satisfaction and outcomes.

What evidence suggests that this protocol is effective for measuring patient engagement in breast cancer?

Research has shown that using Patient Reported Outcome Measures (PROMs) in cancer care can extend patients' lives. One study found that patients using PROMs had a 16% lower risk of dying compared to those who did not. PROMs also help patients understand how treatments affect their daily lives, enhancing their quality of life. In this trial, participants in the Experimental Group will receive graphical results from the PROM survey each time they complete it, enabling them to see how well their treatments work and how they impact their lives. These tools focus on the patient's experience, making care more personalized and effective. ^{2 3 6 7 8}

Who Is on the Research Team?

Sarah Tevis

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adult women (18 years or older) who have been diagnosed with breast cancer and are capable of completing surveys on their own. It's not suitable for anyone under 18, men, or patients unable to fill out surveys independently.

Inclusion Criteria

I have breast cancer.

Patients who can independently complete surveys

I am female.

Exclusion Criteria

Patients who cannot independently complete surveys

I am under 18 years old.

I am male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Patients receive pre-operative PROM surveys, with neoadjuvant chemotherapy patients receiving surveys every 3 months

Varies based on treatment plan

Multiple visits (in-person and virtual)

Post-operative

Post-operative PROM surveys administered at 2 weeks, 3 months, 6 months, 9 months, and 12 months after surgery

12 months

5 visits (in-person or virtual)

Follow-up

Annual PROM surveys conducted after the first year to monitor long-term outcomes

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Patient Reported Outcome Measure Survey

Trial Overview The study focuses on measuring Patient Reported Outcome Measures (PROMs) in breast cancer patients. Feedback from these PROMs will be shared with both the patients and their healthcare providers to assess how it affects patient engagement, service use, and satisfaction with communication.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Patients will receive the results from the PROM survey in graphical form each time they complete a survey.

Group II: Normative Control Active Control 1 Intervention

These patients will complete the PROM surveys, but will not be presented with the results of the survey.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Patient-reported outcomes (PROs) are increasingly important in randomized clinical trials for cancer, as they provide insights into how patients experience treatments, which cannot be captured by clinician reports alone.

The commentary highlights nine clinical trials where PROs significantly contributed to understanding treatment effects, demonstrating their value in guiding clinical practice, informing patients, and aiding health policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to the Patient Voice Adds Value to Cancer Clinical Trials. Brundage, MD., Crossnohere, NL., O'Donnell, J., et al.[2023]

Women with newly diagnosed early-stage breast cancer have significant information needs, and providing them with information can enhance their fighting spirit and reduce feelings of helplessness or hopelessness, based on a review of 537 participants across six studies.

While there is strong evidence that information interventions positively impact immediate emotional responses, the long-term effects on adjustment and well-being are less clear, and inadequate or conflicting information can lead to negative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of the effects of information giving and information needs of women with newly diagnosed early-stage breast cancer: A mixed-method systematic review. Zou, G., Simons, A., Toland, S.[2022]

A study involving 101 childhood cancer survivors, 101 parents, and 36 clinicians revealed significant differences in how these groups rated the importance of patient-reported outcomes (PROs) for survivorship care, highlighting the need for diverse perspectives in developing care tools.

Clinicians rated more items as important in the pain and fatigue domains compared to parents, while survivors placed greater importance on psychological stress and positive affect items, indicating that tailored approaches are necessary for effective survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance ratings on patient-reported outcome items for survivorship care: comparison between pediatric cancer survivors, parents, and clinicians. Jones, CM., Baker, JN., Keesey, RM., et al.[2019]

A study involving 2,245 cancer patients receiving chemotherapy revealed that 20% reported at least one severe toxicity, with significant variations in toxicity rates across different practices, ranging from 8% to 50%.

Commonly reported toxicities included pain and gastrointestinal issues, with 7% of patients requiring unplanned healthcare services, indicating that the severity and impact of side effects may be greater than previously documented in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes collected in ambulatory oncology practices: Feasibility, patterns, and correlates. Friese, CR., Fauer, AJ., Kuisell, C., et al.[2021]

A cross-sectional survey of 4992 cancer survivors in the UK showed that collecting patient-reported outcome measures (PROMs) is feasible, with a 66% response rate, indicating that this method can effectively assess quality of life (QoL) among survivors.

The study found that survivors from more deprived areas reported significantly lower QoL scores, and those with long-term conditions or recurrent disease also experienced poorer outcomes, highlighting the need for targeted support for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of cancer survivors in England 1-5 years after diagnosis: a cross-sectional survey. Glaser, AW., Fraser, LK., Corner, J., et al.[2022]

The review of six studies found that while patient-reported outcome measures (PROMs) are used in cancer clinics, their impact on improving patient outcomes like quality of life and satisfaction is limited, indicating a need for better implementation strategies.

Future interventions should focus on training healthcare professionals to effectively use PROM data, enhancing patient self-efficacy, and ensuring that PROMs are specific and interpretable, while future trials should adopt cluster-randomized designs to better control for contamination and link PROM use to patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Luckett, T., Butow, PN., King, MT.[2022]

A study involving 171 Australian women with breast cancer found that both short and longer surveys assessing health-related quality of life (HrQoL) and psychosocial outcomes were well-received, with high completion rates and positive perceptions regarding their ease and relevance.

Participants expressed the need for more comprehensive questions addressing financial issues, emotional well-being, and treatment side effects, highlighting that while brevity in surveys is important, it should not compromise the assessment of significant outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised online experimental study to compare responses to brief and extended surveys of health-related quality of life and psychosocial outcomes among women with breast cancer. Ettridge, K., Caruso, J., Roder, D., et al.[2022]

The Translational Breast Cancer Research Consortium identified 22 important domains and 52 measurement tools for assessing patient-reported outcomes in breast cancer trials, ensuring they are easily accessible and free of charge.

These selected measures have acceptable psychometric properties, making them reliable tools for evaluating the experiences and outcomes of patients in cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in the Translational Breast Cancer Research Consortium. Bowen, DJ., Shinn, EH., Gregrowski, S., et al.[2021]

The study successfully collected patient-reported outcome measures (PROMs) from 2530 women with gynecologic malignancies, achieving a high completion rate of 78.1%, demonstrating that systematic collection of PROMs in a clinical setting is feasible.

Quality of life scores from this non-trial population were lower than those reported in clinical trials, suggesting that data from trials may not fully represent the experiences of routine patient populations, which is important for informed decision-making in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial findings from a prospective, large scale patient reported outcomes program in patients with gynecologic malignancy. Sisodia, RC., Alimena, S., Ferris, W., et al.[2022]

In a study involving 686 breast cancer patients, it was found that patient-reported outcome measures (PROMs) indicated higher rates of late toxicity compared to clinician assessments, suggesting that patients may experience more side effects than reported by their doctors.

Despite a low concordance rate of 58% between patient and clinician reports, PROMs can effectively identify patients with significant side effects, indicating that they could potentially replace in-person visits to outpatient clinics for follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are PROMs sufficient to record late outcome of breast cancer patients treated with radiotherapy? A comparison between patient and clinician reported outcome through an outpatient clinic after 10years of follow up. Brouwers, PJAM., van Loon, J., Houben, RMA., et al.[2018]

A systematic review identified five patient-reported outcome measures (PROMs) programs in routine cancer care across Europe, highlighting their dual purpose of monitoring individual patient outcomes and improving quality of care.

Despite the potential benefits of these PROM programs, critical issues such as costs, staff resources, and effective reporting methods were often overlooked in the studies, indicating areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of patient-reported outcome assessment in routine cancer care: A systematic review of multicentric programs in Europe. Scheibe, M., Herrmann, A., Schmitt, J., et al.[2022]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822297

Patient-Reported Outcome Measures in Cancer Care The addition of a PROM likely reduced the risk of overall mortality (HR, 0.84; 95% CI, 0.72-0.98; moderate certainty), improved HRQoL (range 0- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9481225/

Patient-Reported Outcome Measures of Breast Cancer Surgery In particular, PROMs in breast cancer surgery allow patients to evaluate the impact and effectiveness of the intervention [8-10]. This study is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624001486

Breast-cancer specific comprehensive archive of Patient ... This study developed a breast cancer specific comprehensive archive of PROMs. This tool promotes a patient-centered approach in clinical research and practice.

4. jpro.springeropen.com jpro.springeropen.com/articles/10.1186/s41687-024-00687-y

Use of patient-reported outcome measures after breast ... Only 21.2% reported PROM response rates, ranging from 43.1 to 96.9%. Barriers and facilitators of PROM use were infrequently noted. Conclusions.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7216450/

Incorporating Patient‐Reported Outcome Measures into ... The ICHOM breast cancer set focuses on meaningful outcomes to patients, with PROs composing 75% of the standard set 2. The PROs proposed (supplemental online ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899941/

Use of patient-reported outcome measures after breast ... This scoping review aims to examine the use of PROMs after post-mastectomy breast reconstruction among patients with breast cancer in LMICs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5357497/

Patient-reported outcome measures of the impact of cancer ... In another study, women with early-stage breast cancer and multiple caregiving roles were found to have elevated depressed mood over time [39]. Additionally, ...

8. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(19)32152-7/pdf

Implementing Patient-Reported Outcome ... Objective: This systematic review aims to give an overview of PROM administration methods and their facilitators and barriers in breast cancer clinical practice ...