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

Completed

• Conditions: Kidney Cancer; Lymphoma; Lung Cancer; Prostate Cancer; Sarcoma; Breast Cancer; Ovarian Cancer; Colorectal Cancer
• Interventions: Other: Geriatric consultation, evaluation questionnaire; Other: Consultation, evaluation questionnaire

• Registration Number: NCT02821793
• Lead Sponsor: Institut Bergonié

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-04
• Primary Completion: 2022-06-30
• Study Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly patient (70 years and older)	Geriatric consultation, evaluation questionnaire	-
Young patient (18 years - 69 years)	Consultation, evaluation questionnaire	-

Primary Outcome Measures

Name	Time	Method
Priorities of patients aged 70 and over and receiving first medical treatment for cancer.	Day 0 initiation of treatment	Main criteria is a prioritization of 4 items selected from a list of 8 expectations regarding the objectives of their treatment : efficacy , life expectancy , autonomy, daily activities , social activities, cumbersome treatment , toxicity, economics
Priorities of patients aged 70 and over and receiving first medical treatment for cancer	3 months after initiation of treatment	Main criteria is a prioritization of 4 items selected from a list of 8 expectations regarding the objectives of their treatment : efficacy , life expectancy , autonomy, daily activities , social activities, cumbersome treatment , toxicity, economics .

Secondary Outcome Measures

Name	Time	Method
Describe expectations of patients 3 months after initiation of treatment	3 months after initiation of treatment
Describe priorities and expectations of patients, at 6 months after initiation of treatment	6 months after initiation of treatment
Describe expectations of patients at initiation of treatment	Day 0 initiation of treatment
Overall survival, according to priorities changing or not	3 months after initiation of treatment
Compare priorities of older subjects compared to younger patients or physician's priorities	3 months after initiation of treatment
Describe 6 months after initiation of treatment, the rate of stable patients in their priorities	6 months after initiation of treatment
Describe 12 months after initiation of treatment, the rate of stable patients in their priorities	12 months after initiation of treatment
Intra- individual reproducibility of the prioritization grid regarding the initial measurement of priorities of the elderly.	Day 0 initiation of treatment
Describe priorities and expectations of patients, at 12 months after initiation of treatment	12 months after initiation of treatment
Describe 3 months after initiation of treatment, the rate of stable patients in their priorities	3 months after initiation of treatment

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France