Clinical trial NCT02821793: Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer
Official title: Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Kidney Cancer
Lung Cancer
Prostate Cancer
Sarcoma
Ovarian Cancer
Lymphoma
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Fondation Université de Bordeaux
name: AG2R La Mondiale
First posted: 2016-07-04
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.

Brief summary: The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.

Detailed description: For the primary endpoint assessment, this self-administered patient questionnaire will used an opinion scale (Not at all, A little, Moderately, Enough, Many) to explore the eight domains. Next to the completion of the expectations questionnaire, patients will have to order 4 of the different 8 items that they prioritized in regard of the first line treatment that has just been prescribed by their physician.

Secondary endpoint will focus on those 8 proposed expectations of patients at different periods of time since treatment initiation. Patients' priorities will be compared to physician's priorities (using the same prioritization grid) before medical treatment and after 3 months of treatment and to younger patients' priorities (18-69 years). Associations between elderly patients' characteristics (social, medical...) and their priorities will be search.

Eligibility criteria: Inclusion Criteria:

1. Male or female:

   1. Age ≥ 70 years
   2. Aged 18-69 years (case population)
2. ECOG / performance status 0-3 (WHO).
3. First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):

   1. Neo-adjuvant setting,
   2. Adjuvant setting: previous neo-adjuvant treatment is allowed,
   3. Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,
4. Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).
5. Life expectancy of more than 3 months.
6. Patients potentially compliant with the rules of the follow-up study.
7. Patients affiliated to a social security scheme.
8. Patients who received clear information from the investigator on the study and had not refused to participate.

Exclusion Criteria:

1. Exclusive surgery treatment.
2. Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).
3. Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:

   1. Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,
   2. Adjuvant setting: previous line(s) of adjuvant medical treatment,
   3. Metastatic setting: previous line(s) of metastatic medical treatment,
4. Supportive care without specific medical treatment
5. Previous or ongoing cancer under treatment at the time of inclusion.
6. Patient already included in this study
7. Patient who for psychological, psychiatric, social, family or geographical reasons could not be regularly monitored according to the criteria of the study; patient private of liberty or under guardianship.

Primary outcomes:
measure: Priorities of patients aged 70 and over and receiving first medical treatment for cancer.
timeFrame: Day 0 initiation of treatment
measure: Priorities of patients aged 70 and over and receiving first medical treatment for cancer
timeFrame: 3 months after initiation of treatment
Secondary outcomes:
measure: Intra- individual reproducibility of the prioritization grid regarding the initial measurement of priorities of the elderly.
timeFrame: Day 0 initiation of treatment
measure: Describe expectations of patients at initiation of treatment
timeFrame: Day 0 initiation of treatment
measure: Describe expectations of patients 3 months after initiation of treatment
timeFrame: 3 months after initiation of treatment
measure: Describe priorities and expectations of patients, at 6 months after initiation of treatment
timeFrame: 6 months after initiation of treatment
measure: Describe priorities and expectations of patients, at 12 months after initiation of treatment
timeFrame: 12 months after initiation of treatment
measure: Describe 3 months after initiation of treatment, the rate of stable patients in their priorities
timeFrame: 3 months after initiation of treatment
measure: Describe 6 months after initiation of treatment, the rate of stable patients in their priorities
timeFrame: 6 months after initiation of treatment
measure: Describe 12 months after initiation of treatment, the rate of stable patients in their priorities
timeFrame: 12 months after initiation of treatment
measure: Overall survival, according to priorities changing or not
timeFrame: 3 months after initiation of treatment
measure: Compare priorities of older subjects compared to younger patients or physician's priorities
timeFrame: 3 months after initiation of treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
References: