New Therapy for Cancer

Overseen By Howard Lim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Investigational agents

Disqualifiers: Cardiovascular disease, Major infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 100 months

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have been treated with any approved or investigational agent or participated in another clinical trial within 14 days before joining this trial.

What data supports the effectiveness of the treatment QOL for cancer?

The research highlights that quality of life (QOL) is an important outcome in cancer treatment, suggesting that treatments focusing on QOL can help identify and address physical and psychological issues, improving overall patient care. This implies that the treatment QOL may be effective in enhancing the well-being of cancer patients by monitoring and addressing their quality of life. ^{1 2 3 4 5}

What safety data exists for the new cancer therapy, possibly known as QOL?

The research articles focus on the quality of life and adverse events related to cancer chemotherapy, but they do not provide specific safety data for the new therapy or QOL treatment. ^{5 6 7 8 9}

How does the treatment QOL differ from other cancer treatments?

The treatment QOL is unique because it focuses on improving the quality of life for cancer patients, rather than just extending survival time. It aims to alleviate symptoms like pain or obstruction caused by tumors, which can enhance daily functioning and overall well-being. ^{3 5 10 11 12}

What is the purpose of this trial?

This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.

Research Team

Cheryl Ho, MD

Principal Investigator

BC Cancer

Eligibility Criteria

This trial is for cancer patients who are interested in participating in a study that evaluates their quality of life and survival with treatments that have shown some promise but need more data to confirm their effectiveness.

Inclusion Criteria

I understand and agree to the study's procedures.

My cancer treatment's effectiveness or cost is uncertain.

I agree to avoid fathering a child or donating sperm for 5 months after my last treatment dose.

Exclusion Criteria

I haven't taken any experimental drugs or joined another clinical trial in the last 14 days.

Inability to complete quality of life questionnaires

I don't have major heart issues, recent serious infections, HIV, TB, or recent major surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive therapy with regular disease assessments and quality of life questionnaires

Up to 100 months

Regular interval visits for disease assessment and QOL questionnaires

Follow-up

Participants are monitored for overall survival and quality of life outcomes

Up to 100 months

Treatment Details

Interventions

• QOL

Trial Overview The trial is testing how certain cancer treatments affect the real world outcomes of patients. It involves regular check-ups using scans or lab tests, along with surveys about the patient's quality of life (QOL).

Participant Groups

Group I: Therapy Experimental Treatment 2 Interventions

Regular disease assessment (eg radiographic imaging) and quality of life (QOL) questionnaires

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Findings from Research

Cancer patients in phase I clinical trials tend to overestimate the potential benefits and underestimate the toxicities of experimental therapies compared to their physicians, indicating a gap in understanding treatment expectations.

The study found a significant correlation between patients' quality of life (QOL) and their perceptions of the benefits of experimental therapy, suggesting that QOL may influence treatment choices and expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of quality of life on patient expectations regarding phase I clinical trials. Cheng, JD., Hitt, J., Koczwara, B., et al.[2022]

Quality of Life (QOL) outcomes are now essential in clinical oncology trials, highlighting their importance in evaluating patient well-being alongside treatment efficacy.

Future QOL studies should prioritize phase III trials with specific hypotheses to ensure that findings lead to meaningful clinical interventions for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life outcomes in oncology. Siddiqui, F., Kachnic, LA., Movsas, B.[2019]

Computer-based quality of life (QOL) assessments in oncology significantly streamline the process of collecting data, making it easier for busy clinical practices to monitor patients' physical and psychological well-being.

These assessments not only help in identifying patients who may need psychological support but also provide valuable data for research and healthcare planning, enhancing overall oncologic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication. Giesinger, J., Kemmler, G., Meraner, V., et al.[2022]

Quality of Life (QOL) assessments are crucial for providing high-quality cancer care and can help test interventions that improve patient outcomes.

Effective communication between patients and healthcare providers is essential for addressing QOL concerns, reinforcing the message that patient well-being is a primary goal in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From research to practice: quality of life assessment in medical oncology. Ferrell, B.[2008]

Evaluating the quality of life for cancer patients during treatment is crucial, as it helps to focus on patient benefits rather than just disease activity.

Improving the assessment of quality of life can enhance clinical investigations and lead to better treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of the quality of life after cancer treatment. Selby, P.[2004]

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 37 men with metastatic prostate cancer, patient-reported symptoms using the QLQ-C30 questionnaire identified 55 symptoms that physicians did not report, highlighting a significant gap in symptom detection by clinicians.

Physician reporting of chemotherapy side effects showed low sensitivity (47%) and specificity (68%) compared to patient reports, indicating that relying solely on clinician assessments may overlook important adverse events experienced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. Fromme, EK., Eilers, KM., Mori, M., et al.[2022]

A survey of 100 cancer patients revealed that their perceptions of chemotherapy side effects have shifted significantly since 1983, with fatigue and psychosocial issues now being the most severe concerns, rather than physical symptoms like nausea.

The study highlights the importance of addressing emotional and social impacts of cancer treatment, as these factors are crucial for improving quality of life, despite advancements in reducing physical side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing patient perceptions of the side effects of cancer chemotherapy. Carelle, N., Piotto, E., Bellanger, A., et al.[2004]

In a study of 1008 patients undergoing outpatient chemotherapy, serious adverse events like malaise, peripheral neuropathy, and limb edema were found to significantly decrease quality of life (QOL), as measured by the EQ-5D-5L scale.

Pharmaceutical care targeting peripheral neuropathy notably improved patients' QOL scores, indicating that collaborative care between pharmacists and physicians can enhance the overall treatment experience for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy. Hirose, C., Fujii, H., Iihara, H., et al.[2021]

Evaluating new cancer treatments should include not only survival rates but also the quality of life (QOL) for patients, as some treatments may alleviate pain or other symptoms even if they do not extend life significantly.

The article provides a review of various QOL measures, including the Functional Assessment of Cancer Therapy (FACT), which can help in assessing the overall impact of cancer treatments on patients' well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life outcomes: measurement and validation. Cella, DF.[2015]

In a study of 100 patients who underwent surgery for oral cancer, the overall quality of life (QoL) score was 58.3, indicating some deterioration, with fatigue, financial issues, insomnia, and pain being the most significant negative factors affecting their QoL.

Despite some challenges, the long-term QoL after oncologic surgery and reconstruction was deemed satisfactory, highlighting the importance of measuring QoL as part of cancer treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longterm quality of life after oncologic surgery and microvascular free flap reconstruction in patients with oral squamous cell carcinoma. Peisker, A., Raschke, GF., Guentsch, A., et al.[2022]

Quality-of-life (QOL) instruments are crucial in clinical research, especially for cancer patients weighing the trade-offs between the side effects of chemotherapy and their overall well-being, as they provide direct insights that surrogate measures cannot.

Recent randomized controlled trials suggest that sharing QOL information with clinicians can lead to improved patient outcomes, highlighting the need for further research to optimize the use of QOL measures in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of the value of health-related quality-of-life information from clinical research and into clinical practice. Guyatt, GH., Ferrans, CE., Halyard, MY., et al.[2022]

References

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

Impact of quality of life on patient expectations regarding phase I clinical trials. [2022]

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

Quality-of-life outcomes in oncology. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication. [2022]

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

From research to practice: quality of life assessment in medical oncology. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Measurement of the quality of life after cancer treatment. [2004]

6. England pubmed.ncbi.nlm.nih.gov

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

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

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. [2022]

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

Changing patient perceptions of the side effects of cancer chemotherapy. [2004]

9. Germany pubmed.ncbi.nlm.nih.gov

Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy. [2021]

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

Quality of life outcomes: measurement and validation. [2015]

11. Spain pubmed.ncbi.nlm.nih.gov

Longterm quality of life after oncologic surgery and microvascular free flap reconstruction in patients with oral squamous cell carcinoma. [2022]

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

Exploration of the value of health-related quality-of-life information from clinical research and into clinical practice. [2022]