Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study
Conditions: Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Sarcoma, Ovarian Cancer, Lymphoma
Sponsor: Institut Bergonié

        
 
 
 
 
EXPECTATIONS AND PRIORITIES OF ELDERLY 
CANCER PATIENTS FOR INITIAL MEDICAL 
TREATMENT  
 
PRIORITY study 
 
Abstract 
 
Version 5.0 of 17/09/2021 
 
Observational study - no. IB 2015 - 06 
 
This study is supported by the Fondation Bordeaux Université and AG2R LA MONDIALE 
 
 
Coordinator 
Dr Camille CHAKIBA 
Department of Medical Oncology 
Medical oncologist 
Institut Bergonié 
 
229, cours de l’Argonne – 33076 BORDEAUX Cedex 
 
Tel: +33 (0)5.56.33.48.17 – Fax: +33 (0)5.56.33.04.85  
 
Email: c.chakiba@bordeaux.unicancer.fr 
 
Scientific manager 
Dr Thomas GRELLETY 
Department of Medical Oncology 
Medical oncologist 
Institut Bergonié 
 
229, cours de l’Argonne – 33076 BORDEAUX Cedex 
 
Tel: +33 (0)5.56.33.04.96 - Fax: +33 (0)5.56.33.04.85 - Email: t.grellety@bordeaux.unicancer.fr 
 
 
Prof. Simone MATHOULIN-PELISSIER 
Institut Bergonié 
Clinical Research and Epidemiology Unit Manager 
 
 
Carine BELLERA 
Institut Bergonié 
Biostatistician 
 
Caroline LALET 
Institut Bergonié 
Clinical Trial Manager Coordinator 
 
 
 
 
SPONSOR 
INSTITUT BERGONIÉ 
 
 

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STUDY ABSTRACT 
SPONSOR 
INSTITUT BERGONIE 
COORDINATOR 
 Dr Camille CHAKIBA 
SCIENTIFIC MANAGER 
Dr Thomas GRELLETY 
TITLE 
Expectations and priorities of elderly cancer patients for initial 
medical treatment. PRIORITY study. 
RATIONALE / BACKGROUND 
Approximately 60% of cancers occur in people over 65, but these 
patients are proportionately under-represented in clinical trials. As a 
result, the impact of anti-cancer treatments on these patients is 
poorly taken into account, which can affect the quality of their care. 
The 2014-2019 Cancer Plan states that clinical research in geriatric 
oncology must be designed to take better account of the objectives of 
the proposed treatment. This requires a new definition of outcome 
measures, adjusted to patients' priorities. Indeed, overall survival, 
which represents the amount of life gained, is not sufficient to assess 
the expectations of elderly people, who legitimately have more 
qualitative expectations, such as quality of life or the impact of 
treatment on different areas of life (cognitive, social, functional, etc.). 
Apart from quality of life and improved survival, there are currently 
no guidelines for evaluating cancer treatments in the elderly 
population using more qualitative measures. Elderly patients need to 
be repositioned at the centre of their assessments to enable a more 
precise understanding of the real benefits and consequences of 
medical treatment. The PRIORITY study proposes to identify and 
evaluate changes in the expectations and priorities of these patients, 
when faced with first-line cancer medical treatment. 
OBJECTIVES 
 
Primary objective 
To describe the priorities of patients 70 years of age and older 
receiving first medical treatment for cancer, at treatment initiation 
and 3 months after treatment initiation. 
The primary outcome measure is a prioritisation of 4 items by 
patients, from a list of 8 expectations concerning the objectives of 
their treatment: efficacy of treatment, life expectancy, autonomy, 
daily tasks, social activities, burden of treatment, toxicity, economic 
aspect. 
 
Secondary objectives  
 To assess the intra-individual reproducibility of the expectations 
prioritisation grid concerning the initial measurement of the 
priorities of elderly subjects. 
 In patients aged 70 and over receiving initial medical treatment for 
cancer: 
- 
To describe patient expectations, at treatment initiation and 3 
months after treatment initiation. 
- 
To describe patient priorities and expectations, 6 and 12 
months after treatment initiation. 
- 
To describe, 3, 6 and 12 months after initiation of treatment, 
the proportion of patients whose priorities are stable 
compared with when treatment was initiated. 
- 
To look for associations between patients' characteristics (at 

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initiation of treatment) and their priorities (at initiation of 
treatment and 3 months after initiation of treatment).  
- 
To describe overall survival in 2 groups of patients defined 
according to whether or not their priorities at 3 months were 
stable compared with their priorities at initiation of 
treatment. 
 For 2 groups of subjects (1- patients aged 70 and older and 
receiving initial medical treatment for cancer; 2- patients aged 
under 70 and receiving initial medical treatment for cancer):  
- 
To study the perception of the disease at initiation of 
treatment, 
- 
To look for an association between the perception of the 
disease at treatment initiation and a change in priorities 
between treatment initiation and 3 months after, 
- 
To look for an association between the perception of the 
disease at treatment initiation and the quality of life at 
treatment initiation, 
- 
To look for an association between the perception of the 
disease at treatment initiation and the change in quality of life 
between treatment initiation and 3 months after. 
 For 3 groups of subjects (1- patients aged 70 and over and 
receiving initial medical treatment for cancer; 2- patients aged 
under 70 and receiving initial medical treatment for cancer; 3- 
medical oncologists and oncogeriatricians): to compare subjects' 
priorities at initiation and 3 months after initiation of treatment. 
STUDY DESIGN 
This is a prospective study, for which recruitment will be conducted in 
two parts: 
- 
Part 1: Institut Bergonié single-centre phase (patient 
population aged 70 and over)  
- 
Part 2: national multi-centre phase. The main population will 
be patients aged 70 years and older. In parallel, a control 
population of patients aged 18 to 69 will be set up. The 
inclusion and exclusion criteria will be identical for both 
populations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INCLUSION CRITERIA 
1. Man or woman: 
a. Age ≥ 70 years 
b. 18 to 69 years of age (control population) 
2. Living conditions 0-3 (WHO index). 
3. First-line medical treatment for cancer (chemotherapy, targeted 
Population ≥ 70 years 
400 patients 
80 patients 
320 patients 
Population < 70 years 
100 patients 
+ 
PART 2 
National multi-
centre phase 
PART 1 
Institut Bergonié 
single-centre phase 

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therapy, hormone therapy, combination): 
a. neoadjuvant 
b. adjuvant; prior neoadjuvant medical treatment is permitted, 
c. advanced/metastatic; prior neoadjuvant and/or adjuvant 
medical treatments are permitted. 
d. For prostate cancers: patients with biological relapse without 
metastasis present are eligible in the advanced/metastatic 
disease group. 
4. Solid tumours (colorectal, ovarian, endometrium, lung, prostate, 
bladder, breast, sarcoma and kidney) and lymphoma (indolent 
and aggressive). 
5. Life expectancy greater than 3 months. 
6. Patients potentially compliant with the study follow-up rules. 
7. Patients affiliated to a social security scheme. 
8. Patients who have received clear information from the 
investigator about the study and have not refused to participate. 
EXCLUSION CRITERIA 
1. Treatment by exclusive surgery. 
2. Radiotherapy alone or in combination with medical treatment 
(radio-hormone therapy or concomitant radio-chemotherapy). 
3. Patient having already received a first line of medical treatment 
in the same indication as that at the time of patient enrolment in 
the trial: 
a. Patient in a neoadjuvant situation: having already received 
one or more lines of neoadjuvant medical treatment, 
b. Patient in an adjuvant situation: having already received one 
or more lines of adjuvant medical treatment, 
c. Patient in a metastatic situation: having already received one 
or more lines of metastatic medical treatment, 
4. Supportive care without specific medical treatment.  
5. History of another cancer being treated at the time of inclusion.  
6. Patient already included in this study. 
7. Patients who, for psychological, psychiatric, social, family or 
geographical reasons, could not be regularly monitored according 
to the study criteria; patients deprived of their liberty or under 
guardianship. 
NATURE OF THE INTERVENTION 
ASSESSED IN THE RESEARCH 
Patients' expectations and priorities will be assessed using two self-
assessment questionnaires which will be carried out before the 
initiation of treatment and at 3, 6 and 12 months after the initiation of 
treatment. 
OUTCOME MEASURES 
Primary outcome measure 
 
Description of the questionnaires 
1. The expectations questionnaire: our questionnaire consists of 8 
items, graded using an opinion scale (Not at all, Somewhat, 
Moderately, Fairly, Very much): 
- Efficacy of prescribed treatment for cancer  
- Life expectancy  
- Autonomy  
- Daily tasks  
- Social activities  
- Burden of treatment   
- Toxicity 
- Economic aspect  
 
2. A prioritisation grid: comprising four choices to gather patients' 
priorities regarding their specific treatment, from among the eight 

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items in the expectations above. 
 
These questionnaires will be given to patients at the end of 
the consultation by the investigating physician, the CRA or the 
UCOG (oncogeriatric coordination unit) nurse. They will be 
given before initiation and at three, six months, and twelve 
months after treatment initiation.  
 
Primary outcome measure analysis 
The ranking of priorities will be summarised by calculating the 
percentage of patients placing an item among their four priorities, i.e. 
assigning a value of 1.2, 3 or 4 to that item. Calculations will be 
performed separately for each item. For each item, we will describe 
the percentage of patients who prioritised the item concerned out of 
the 4 top items, then the percentage of patients who indicated the 
item as the 1st item to be prioritised. 
 
Secondary outcome measures 
 Each item concerning patients' expectations (treatment efficacy, 
life expectancy, autonomy, daily tasks, social activities, burden of 
treatment, toxicity, economic aspect) will be described individually 
at the different measurement times of interest (initiation of 
treatment, 3, 6 and 12 after initiation) 
 Expextation stability is defined, for an item on the expectations 
questionnaire, by an identical response at treatment initiation and 
at the subsequent measurement time of interest (3, 6 and 12 
months after treatment initiation) 
 Priority stability is defined by identical prioritisation (the same 4 
expectations selected and rated in the same order) between 
treatment initiation and the subsequent measurement time of 
interest (3, 6 and 12 months after treatment initiation) 
 Associations will be sought between patient priorities at treatment 
initiation, then at 3 months with the following characteristics: 
- Patient's age, 
- Sex (M or F),  
- Educational level (last degree obtained),  
- Living environment (urban or rural) / Isolation (living alone 
yes/no),  
- Cancer location, 
- Line of treatment (neoadjuvant, adjuvant, metastatic), 
- Type of treatment (chemotherapy, hormone therapy, 
targeted therapy), 
- Quality of life, 
- Complete oncogeriatric assessment, 
- Co-morbidities, 
- General condition, 
- Toxicity, 
- Progression of the disease. 
 Quality of life is defined by the EORTC QLQ-C30 questionnaire and 
by the elderly-specific module QLQ-ELD14  
 Disease perception at treatment initiation will be assessed using 
the “Brief Disease Perception Questionnaire” (Bref Questionnaire 
de Perception de la Maladie - BQPM). 
 A full oncogeriatric assessment will be carried out during the initial 
consultation and will include the systematic performance of the 
following tests: 

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- Instrumental Activities of Daily Living (IADL, Lawton & 
Brody, Gerontologist 1969), and Activities in Daily Living 
(ADL, Katz et al. JAMA 1963), 
- Get up and go test (Mathias et al, Arch Phys Med Rehabil. 
1986) 
- Mini Nutritional Assessment (MNA; Guigoz et al. 
FactsResGerontol 1994) 
- Mini Mental State Examination (MMSE; Folstein et al. J 
PsychiatrRes 1975), 
- Geriatric Depression Scale (GDS-15; Sheikh et al. Clin 
Gerontol 1986). 
- Co-morbidities will be assessed at the beginning of the 
study by the Cumulative Illness Rating Scale-Geriatric 
(CIRS-G; Extermann et al. J Clin Oncol 1998). 
 Overall condition will be assessed by the WHO living conditions 
score at the four time points of the assessment,  
 Toxicity will be assessed by collecting the following events at the 
three time points of the assessment (3, 6 and 12 months): 
- Unscheduled hospitalisation and cause, 
- Postponement of treatment due to toxicity, 
- Dose adjustment due to toxicity, 
- Treatment discontinuation due to toxicity, 
- Febrile neutropenia. 
 Disease progression will be determined at 3, 6 and 12 months of 
treatment according to the investigator’s clinical judgement based 
on the standard criteria in force: 
- RECIST criteria (Eisenhauer et al., Eur J Cancer 2009) for 
solid tumours,  
- PSA, RECIST (visceral locations), PET Scan (bone lesions) for 
prostate cancers (Scher, J Clin Oncol, 2008 and 2011), 
-  Lugano Lymphoma classification criteria (Cheson et al. J 
Clin Oncol 2014).  
 Overall survival is defined as the time between the date of 
inclusion and the date of death from any cause. 
 The repeatability of the prioritisation grid developed in this study 
will be assessed by administering the prioritisation grid twice to a 
sample of 80 patients for the initial measurement of priorities: 
once at the time of the initial consultation and then a second time, 
for example at the start of treatment visit, and within no more 
than 10 days.  
 For 3 groups of subjects (1- patients aged 70 and over and 
receiving initial medical treatment for cancer; 2- patients aged 
under 70 and receiving initial medical treatment for cancer; 3- 
medical oncologists and oncogeriatricians): the subjects' priorities 
at initiation and 3 months after initiation of treatment will be 
compared.  
STUDY SIZE 
Total (Part 1 and Part 2): 
400 patients in the main population (≥ 70 years)  
100 patients in the control population (aged 18 to 69). 
Part 1:  
80 patients in the main population (≥ 70 years)  
 
Part 2:  
320 patients in the main population (≥ 70 years)  

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100 patients in the control population (aged 18 to 69). 
EXPECTED NUMBER OF CENTRES 
Part 1: Institut Bergonié single-centre study 
Part 2: multi-centre study (approximately 10 national centres) 
STUDY DURATION 
Part 1: 
- Duration of the inclusion period: 8 months 
- Participation time for each patient: 12 months 
- Total study duration: 20 months 
Part 2: 
- Duration of the inclusion period: 48 months 
- Participation time for each patient: 12 months 
- Total study duration: 60 months 
DATA STATISTICAL ANALYSIS 
Study size 
 For this descriptive study, we wish to limit the inclusion period to 24 
months.  
 The first part, carried out at Institut Bergonié, will enable us to 
assess the reproducibility of the expectations questionnaire. For this 
part, we wish to include 80 subjects aged 70 and over. The 
experience of the ONCODAGE study (Soubeyran et al, Plos One 
2014) (200 patients included in 20 months at the Institut Bergonié), 
allows us to estimate the feasibility of inclusion for this first stage, 
with 80 patients included in 8 months.  
 For the second part, we wish to include 320 patients aged 70 and 
over and 100 patients under 70. Based on the experience of the 
ONCODAGE study (Soubeyran et al, Plos One 2014) (approximately 
1,600 patients included in 18 months in 20 centres at national level), 
we estimated the feasibility of inclusion for this second stage, with 
420 patients included in 18 months. As the rate of inclusions was 
slower than expected, the inclusion period was extended to 48 
months. 
 
Statistical methods used 
Primary outcome measure 
 The analysis of the primary outcome measure will focus on the 
population that is eligible and evaluable for the primary outcome 
measure. 
 Expectations: for each time point of interest, the distribution of 
response modalities (not at all; somewhat; moderately; fairly; very 
much) is plotted for each of the eight items, using frequencies and 
percentages. Missing values will also be reported. 
 Priorities: for each time point of interest, the expectations reported 
as priorities will be plotted, in terms of frequency and percentages.  
 Additional analyses will be carried out to assess any response shift 
(RS) phenomena. 
Secondary outcome measures 
 Quality-of-life questionnaires 
 The QLQ-C30 quality of life questionnaire (outside the three 
targeted sub-scales for the co-primary outcome measure) will be 
analysed following the guidelines in the EORTC Scoring Manual. 
The same applies to the QLQ-ELD14 questionnaire. 
 The scores will be analysed if at least half of the items on the 
corresponding scale have been answered.  
 Descriptive statistics of raw and standardised QLQ-C30 and QLQ-
ELD14 scores and change from inclusion will be calculated at 

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each visit time and for each arm. 
 A cross-sectional analysis will be carried out with a graphical 
representation of the scores per treatment arm at the different 
time points. 
 Disease perception (BQPM questionnaire) 
 The distribution of subjects by modality (pessimistic, realistic, 
optimistic) will be reported (frequency, proportion and 95% 
confidence interval) by population of interest. 
 Associations with quality of life and changes in priorities will be 
sought (chi2 test or non-parametric test depending on the 
distribution of the variables) 
  Geriatric parameters  
 For each of the geriatric scales, the scores will be analysed. 
 Quantitative analysis: Scores will be described from mean values 
(+/- standard deviation) if the normality assumption is satisfied, 
and failing that on the basis of other descriptive statistics 
(median, range, quartiles). The scores will be described at each 
time point of interest. 
 Qualitative analysis: the rate of subjects with an abnormal score 
will be reported (frequency, proportion and 95% confidence 
interval) at each time point of interest. 
 The reproducibility analysis will be carried out on the population of 
eligible patients who completed the expectations questionnaires 
and the prioritisation grid on 2 occasions before the initiation of 
treatment, within a period of between 3 and 10 days. The 
reproducibility of the expectations questionnaire will be assessed by 
the kappa concordance coefficient; values of the kappa coefficient 
above 0.75 correspond to acceptable reproducibility. 
 Contingency tables will be presented for the priorities of the 3 
groups of subjects, and a comparison will be made using a chi-2 test 
(or, failing that, a Fisher test). 
 Associations between prioritisations and patient characteristics will 
be investigated using a Chi-square test (univariate analyses) and 
logistic modelling (multivariate analyses). 
 Survival data will be described using the Kaplan-Meier method 
(median survival, probability of survival at 1 year) and presented 
with their 95% confidence intervals. 
 Quantitative variables will be described from mean values (+/- 
standard deviation) if the normality assumption is satisfied, and 
failing that on the basis of other descriptive statistics (median, 
range, quartiles). 
 Qualitative variables will be described based on frequency, 
percentage and 95% confidence interval (binomial law). 
 Missing data will be reported (per item and per questionnaire) using 
frequency and percentage.  
 Kappa coefficients will be evaluated, along with their 95% 
confidence intervals, and compared using the method described by 
Fleiss (Third Ed. 2003). 
 The application conditions will be checked for all analyses that will 
be carried out. All tests will be carried out with a risk of error of the 
first kind α=5% and will be exploratory.  
 
Two interim analyses will be planned: 
 
A first interim analysis will be planned at the end of Part 1 of the 

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study, i.e. once the data of the first 80 patients enrolled at Institut 
Bergonié (elderly population) are available. A reproducibility 
analysis will be carried out on these 80 patients and the results 
will be discussed by the steering committee. 
 
A second interim analysis will be planned once 250 patients have 
been included in the elderly population, in order to describe the 
inclusions according to the different cancer locations. These 
results will be analysed by the steering committee in order to 
decide on any changes to the inclusion criteria, in order to ensure 
the inclusion of all tumour locations. 
EXPECTED BENEFITS 
For patients: 
Better consideration of patient expectations with the following 
consequences: 
- direct improvement in patients' experience of treatment as a result 
of listening to their objectives, particularly with regard to the risk of 
hospitalisation and adverse effects,  
- better definition of the indications for cancer treatments in this 
population, where evidence from clinical trials is lacking, 
- improved quality of life. 
 
For public health: 
- Improved quality of clinical trials in oncogeriatrics in line with the 
guidelines of the 2014-2019 Cancer Plan, by proposing more 
appropriate outcome measures, 
- Improved recruitment and relevance of the results of these future 
clinical trials thanks to a more specific design, 
- Improved cost/effectiveness ratio of treatments prescribed in 
oncogeriatrics by improving patient compliance. 
- Possible extension of the use of composite outcome measures based 
on patient expectations to other serious diseases (severe heart 
failure, chronic respiratory failure, chronic end-stage renal failure, 
etc.) 
 
 

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Elderly patient follow-up summary table 
 
Patient Part 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Initial 
consultation 
3 months 
6 months 
12 months 
Information note 
X 
 
 
 
History of the disease/previous 
treatments 
X 
 
 
 
WHO general condition 
X 
X 
X 
X 
Height, weight 
X 
X 
X 
X 
Priorities and Expectations 
Questionnaire 
X 
X 
X 
X 
Quality of life 1 
X 
X 
X 
X 
BQPM 
disease 
perception 
questionnaire ² 
X 
 
 
 
Initial geriatric assessment 3 
X 
 
 
 
Simplified geriatric assessment 4 
 
X 
X 
X 
Treatment toxicity 5 
 
X 
X 
X 
Tumour evaluation 6 
 
X 
X 
X 
Concomitant oncology treatments 7 
 
X 
X 
X 
Physician part8 
 
 
 
 
Priorities questionnaires 
X 
X 
X 
X 
 
1 EORTC QLQ-C30, QLQ-ELD14 questionnaires. To be completed for 12 months, even if the treatment line is 
changed and/or the disease progresses and/or specific treatments are discontinued. 
² BQPM questionnaire, to be completed at the initial visit only. 
3 The initial geriatric assessment includes: CIRS-G (Co-morbidities and associated treatments), Socio-economic 
Questionnaire, ADL, IADL, MNA, MMS, GDS15, GUAGT.  
4 The simplified geriatric assessment includes: ADL, IADL and changes concerning housing/environment/family 
and aid (shortened socio-economic questionnaire). The geriatric assessment will be continued for 12 months, 
even if the treatment line is changed and/or the disease progresses and/or specific treatments are discontinued. 
5 Collection of the following information: febrile neutropenia, unscheduled hospitalisation, delayed treatment, 
dose adjustment, discontinuation of treatment due to toxicity. 
6 Tumour assessment planned by the referring physician as part of the patient's normal cancer follow-up, based 
on current standard criteria (RECIST 2009 criteria for solid tumours, Scher criteria - PSA and/or RECIST- for 
prostate cancer and Cheson for lymphoma).  
7 Treatment line changes must be recorded with their date and type of change (chemotherapy, hormone 
therapy, targeted therapy). Similarly, concomitant treatments such as surgery, radiotherapy or interventional 
radiology related to the cancer should be recorded, along with their date and type, throughout the patient's 
follow-up period. 8 Collection of some information about the physician at the start of the study (year of birth, 
number of years of exercise, training in oncogeriatrics). 
 
 

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Young patient follow-up summary table 
 
Patient Part 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Initial 
consultation 
3 months 
6 months 
12 months 
Information note 
X 
 
 
 
History of the disease 
X 
 
 
 
WHO general condition 
X 
X 
X 
X 
Height, weight 
X 
X 
X 
X 
Priorities and Expectations 
Questionnaire 
X 
X 
X 
X 
Quality of life 1 
X 
X 
X 
X 
BQPM disease perception 
questionnaire ² 
X 
 
 
 
Treatment Toxicity 3 
 
X 
X 
X 
Tumour evaluation 4 
 
X 
X 
X 
Concomitant oncology treatments 5 
 
X 
X 
X 
Physician Part6 
 
 
 
 
Priorities questionnaires 
X 
X 
X 
X 
1 EORTC QLQ-C30 questionnaire. To be completed for 12 months, even if the treatment line is changed and/or 
the disease progresses and/or specific treatments are discontinued. 
² BQPM questionnaire, to be completed at the initial visit only. 
3 Collection of the following information: febrile neutropenia, unscheduled hospitalisation, delayed treatment, 
dose adjustment, discontinuation of treatment for toxicity. 
4 Tumour assessment planned by the referring physician as part of the patient's normal cancer follow-up, based 
on current standard criteria (RECIST 2009 criteria for solid tumours, Scher criteria - PSA and/or RECIST- for 
prostate cancer and Cheson for lymphoma).  
5 Treatment line changes must be recorded with their date and type of change (chemotherapy, hormone 
therapy, targeted therapy). Similarly, concomitant treatments such as surgery, radiotherapy or interventional 
radiology related to the cancer should be recorded, along with their date and type, throughout the patient's 
follow-up period.  
6 Collection of some information about the physician at the start of the study (year of birth, number of years of 
exercise, training in oncogeriatrics).