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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy for cancer patients, called QOL, to evaluate its impact on quality of life and survival in real-world settings. The goal is to gather evidence on the treatment's effectiveness and cost-efficiency. Participants will regularly undergo disease assessments, such as scans, and complete quality of life questionnaires. The trial seeks individuals with cancer who have questions about the treatment's effectiveness or cost, can complete questionnaires, and have a life expectancy of at least 12 weeks. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance future cancer treatments.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that treatments aimed at improving quality of life (QOL) can affect cancer patients differently. Some studies have found that these treatments enhance overall well-being, but this is not always the case. In fact, only a few new cancer treatments have led to better quality of life. However, when improvements occur, they can significantly impact how patients feel each day.

One study showed that treatments using only radiation therapy reduced symptoms like tiredness, nausea, and vomiting. This suggests that some QOL-focused treatments might be more effective than others.

While QOL treatments are designed to improve daily life, the evidence on their effectiveness is mixed. Although these treatments are generally safe, their ability to enhance life quality can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it focuses on enhancing the quality of life (QOL) for cancer patients, which is often overlooked in traditional therapies. Unlike standard treatments that primarily aim to shrink tumors or manage symptoms, this approach combines regular disease assessments with QOL questionnaires to prioritize patient wellbeing alongside clinical outcomes. This dual focus could lead to more personalized care, ensuring treatments align better with individual patient needs and improving overall patient satisfaction.

What evidence suggests that this treatment might be an effective treatment for cancer?

Research has shown that improving quality of life (QOL) can enhance cancer treatment outcomes. In a review of studies, 89% found a link between better QOL and positive outcomes, such as longer survival. This highlights the importance of focusing on QOL in cancer care. Previous studies also found that psychological support improved QOL for cancer patients, though the benefits diminished over time. This trial will focus on therapies aimed at improving QOL, potentially enhancing the well-being of cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Cheryl Ho, MD

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2059702924014236

Association between health-related quality-of-life results ... Among these, global QoL results were positive in 55 (38.5%) and 56 studies (39.4%), respectively. QoL results were available for most drugs approved by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9052107/

Association of Quality-of-Life Outcomes in Cancer Drug ... Association of QOL Benefit With Other Efficacy Measures. Of the 45 included trials, 40 (89%) had data reported for OS and 42 (93%) had data for ...

3. nature.com nature.com/articles/s41598-024-63431-y

Psychological intervention improves quality of life in ... The effect of PI on QoL was generally positive immediately, 12 and 24 weeks after intervention, but the effect decreased over time and was no ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)02670-9/fulltext

695P Effectiveness and quality-of-life (QoL) data from real ... Real-world data from ProNiHN shows that nivo is effective in a broad patient population. The safety data collected is consistent with the known safety profile.

5. bmjoncology.bmj.com bmjoncology.bmj.com/content/2/1/e000062

Modern cancer trials still lack information about QoL ... Perhaps the most disappointing finding in the study was that 70% of trials had still not reported the QoL results as long as 2 years after the ...

6. cancernetwork.com cancernetwork.com/view/exclusive-radiation-therapy-improves-qol-and-safety-outcomes-in-breast-cancer

Exclusive Radiation Therapy Improves QOL and Safety ... Per the QLQ-C30 symptom scales, the radiation therapy group had more favorable outcomes for most symptoms including fatigue, nausea and vomiting ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10546820/

Quality of Life and Treatment-Related Side Effects in ... The survey was completed by 502 HCPs and 467 patients. Overall, 88% of oncologists and 49% of patients recalled QOL discussions at follow-up. In ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2791674

Association of Quality-of-Life Outcomes in Cancer Drug ... Most cancer drug trials that show improved progression-free survival do not show improved patient global QOL; however, this outcome is reported favorably.