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

NCT ID: NCT02821793

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly patient (70 years and older)

Geriatric consultation, evaluation questionnaire

Intervention Type: OTHER

Geriatric consultation, evaluation questionnaire

Young patient (18 years - 69 years)

Consultation, evaluation questionnaire

Intervention Type: OTHER

Consultation, evaluation questionnaire

Interventions

Consultation, evaluation questionnaire

Consultation, evaluation questionnaire

Intervention Type: OTHER

Geriatric consultation, evaluation questionnaire

Geriatric consultation, evaluation questionnaire

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Université de Bordeaux

UNKNOWN

Sponsor Role: collaborator

AG2R La Mondiale

OTHER

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Bergonié

Bordeaux, , France

Countries

France

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IB 2015-06

Identifier Type: -

Identifier Source: org_study_id