Quality of Life in Cancer Decision-Making and Research

Educational Objectives

The goal of this program is to improve assessment of quality of life (QOL) in patients with cancer. After hearing and assimilating this program, the clinician will be better able to:

1. Evaluate the impact of QOL research on clinical practice.
2. Advocate for inclusion of QOL outcomes in clinical trials.

Summary

Definitions: patient-reported outcome (PRO) — any aspect of health status directly reported by the patient; patient-reported outcome measure (PROM) — a tool used for measuring PROs (eg, European Organization for the Research and Treatment of Cancer Quality-of-Life Core Questionnaire [EORTC QLQ-C30]); health-related quality of life (QOL) — an individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns

Patient-reported outcomes: includes QOL, which is multidimensional and encompasses, eg, symptom scales, functional health status scales, utility; commonly assessed PROs include PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE); other PROs — satisfaction with care; adherence to medication

Evolution of QOL research: the Karnofsky and Zubrod scores assess performance status; in 1978, the term “QOL” was coined at the World Congress of Sociology and has been increasingly used since; development of multidimensional QOL instruments — the first cancer-specific QOL instrument was the Functional Living Index-Cancer (FLIC); the EORTC QOL group developed the QLQ-C30; in the United States, the 36-item Short Form Health Survey (SF-36; a popular generic QOL instrument) was developed as part of the Medical Outcomes Study; cancer-specific instruments assess symptoms of patients with cancer and can be used for any malignancy (allows comparison with generic QOL); Stevens et al (2011) developed a QOL questionnaire for patients with enteral feeding tubes (QOL-EF); the US Food and Drug Administration issued a draft guidance on QOL research; the direction and use of QOL research differs among stakeholders (eg, regulators, pharmaceutical companies, clinicians)

Standardization of QOL instruments: improves the quality of data; guidance is available on designing protocols that use QOL instruments and data reporting; work on statistical analysis is ongoing; the PROTEUS consortium collates guidelines on QOL and PROs on its website

QOL in cancer trials: in a trial on brain metastasis, quality-adjusted life-years was used as a PRO; head and neck cancer (HNC) — Ringash et al (2017) analyzed 19 randomized trials with QOL end points; 3 trials showed a difference in QOL by arm (ie, intensity-modulated radiation therapy [IMRT], accelerated radiotherapy [Nyqvist et al {2016}], and conventional radiotherapy); most trials showed no difference in QOL between the arms; in another review of randomized trials after 2017, 5 of 14 studies showed statistically significant differences in QOL by arm; only 1 of the 5 was a cancer treatment trial (comparing nivolumab vs standard chemotherapy in metastatic HNC); the other trials focused on supportive care (ie, a structured exercise program, cognitive behavioral therapy, and a thyme-honey mouth rinse)

Lack of positive QOL results: translation into overall QOL improvements requires a large effect because it is dependent on a wide range of patient factors; patients adapt to living with cancer; QOL benefits are predominantly observed with supportive (short-term) interventions; curative interventions require larger efficacy to improve general well-being outcomes; QOL benefits have been observed with curative interventions that represent paradigm shifts in clinical practice (eg, IMRT, fractionation, immunotherapy)

Utility of including QOL data: in trials that focus on survival, decide whether including QOL data will be clinically meaningful; consider whether an intervention would be practice-changing and accepted by patients and clinicians on the basis of QOL data (eg, IMRT vs conventional radiation therapy was practice changing); Pow et al (2006) showed that, in nasopharyngeal cancer, IMRT significantly improved QOL

Scenarios necessitating QOL data: when survival rates with different treatments are similar (eg, radical radiotherapy vs prostatectomy in prostate cancer), QOL data may help patients choose among treatments based on AEs and post-treatment challenges, despite the lack of a statistically significant difference; when treatment improves survival but is associated with severe AEs, PRO-CTCAE may help patients understand what effects they are likely to experience and make a decision on treatment; QOL data may be important when cure is unlikely or in chronic diseases with high survival rates; in trials on supportive or palliative treatments, QOL may be the primary outcome

Future role of QOL: Karnofsky recognized that tumor response is meaningless if the patient is bedridden by the treatment; consider matching the outcome to the intervention; although not all interventions are likely to improve QOL, QOL data may help understand patients’ experiences and recognize or rule out unanticipated AEs; standardization of QOL data analysis aims to extract the most value from data provided by patients; increasing use of PRO-CTCAE in clinical trials is expected

Symptom-specific hypothesis: in the HE.1 trial, Dawson et al (2023) randomized patients with end-stage liver cancer and abdominal pain to single-fraction radiotherapy vs best supportive care; the outcome was patient-reported pain; although the difference in overall QOL was not statistically significant, the pain response was significant and durable; the patient-reported symptom-specific hypothesis, may be increasingly tested in the future, rather than relying on overall QOL

Questions and Answers

Clinical use of QOL data in large health care systems: studies show that measuring PROs and responding to the results improve the well-being and survival of patients; however, simply measuring QOL data without appropriate response is not beneficial; clear allocation of responsibility for data analysis and devising an algorithm for appropriate response is necessary; mobile applications may be increasingly used for this purpose in the future; health care systems need to provide reimbursement for capture and analysis of QOL data

Readings

Charalambous M, Raftopoulos V, Paikousis L, et al. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018;34:89-97. doi:10.1016/j.ejon.2018.04.003; Dawson LA, Fairchild AM, Dennis K, et al. Canadian Cancer Trials Group HE.1: A phase III study of palliative radiotherapy for symptomatic hepatocellular carcinoma and liver metastases. Journal of Clinical Oncology. Published online January 24, 2023. doi:10.1200/JCO.2023.41.4_suppl.LBA492; Nyqvist J, Fransson P, Laurell G, et al. Differences in health related quality of life in the randomised ARTSCAN study; accelerated vs. conventional radiotherapy for head and neck cancer. A five year follow up. Radiother Oncol. 2016;118(2):335-341. doi:10.1016/j.radonc.2015.12.024; Ringash J. Survivorship and quality of life in head and neck cancer. J Clin Oncol. 2015;33(29):3322-3327. doi:10.1200/JCO.2015.61.4115; Ringash J. Quality of life in head and neck cancer: where we are, and where we are going. Int J Radiat Oncol Biol Phys. 2017;97(4):662-666. doi:10.1016/j.ijrobp.2016.12.033; Stevens CSM, Lemon B, Lockwood GA, et al. The development and validation of a quality-of-life questionnaire for head and neck cancer patients with enteral feeding tubes: the QOL-EF. Support Care Cancer. 2011;19(8):1175-1182. doi:10.1007/s00520-010-0934-6.

Disclosures

For this program, members of the faculty and planning committee reported nothing relevant to disclose.

Acknowledgements

Dr. Ringash was recorded at UCSF Radiation Oncology Update: Patient-Centered Radiation Oncology 2023, held on April 15, 2023, in San Francisco, CA, and presented by the University of California, San Francisco School of Medicine. For information about upcoming CME activities from this presenter, please visit https://meded.UCSF.edu. Audio Digest thanks the speakers and the University of California, San Francisco School of Medicine for their cooperation in the production of this program.

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 1.00 CE contact hours.

Lecture ID:

UR470401

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.