Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer (PRIORITY)

Institut Bergonié

Status: Completed

Conditions: Breast Cancer; Sarcoma; Lung Cancer; Kidney Cancer; Lymphoma; Ovarian Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Other: Consultation, evaluation questionnaire; Other: Geriatric consultation, evaluation questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT02821793

IB 2015-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

346 participants in 2 patient groups

Elderly patient (70 years and older)

Treatment:

Other: Geriatric consultation, evaluation questionnaire

Young patient (18 years - 69 years)

Treatment:

Other: Consultation, evaluation questionnaire