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

Breast Cancer Clinical Trial

— PRIORITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821793
• Other study ID #: IB 2015-06
• Status: Recruiting
• Start date: January 2016
• Est. completion date: July 2020

Study information

• Verified date: September 2018
• Source: Institut Bergonié
• Contact: SOUBEYRAN Pierre-Louis, MD, PhD
• Email: p.soubeyran[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Lung Cancer
• Lymphoma
• Ovarian Cancer
• Prostate Cancer
• Sarcoma

Intervention

Other:
• Consultation, evaluation questionnaire
Consultation, evaluation questionnaire
• Geriatric consultation, evaluation questionnaire
Geriatric consultation, evaluation questionnaire

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
Institut Bergonié	AG2R La Mondiale, Fondation Université de Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Priorities of patients aged 70 and over and receiving first medical treatment for cancer.	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	Day 0 initiation of treatment
Primary	Priorities of patients aged 70 and over and receiving first medical treatment for cancer	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 .	3 months after initiation of treatment
Secondary	Intra- individual reproducibility of the prioritization grid regarding the initial measurement of priorities of the elderly.		Day 0 initiation of treatment
Secondary	Describe expectations of patients at initiation of treatment		Day 0 initiation of treatment
Secondary	Describe expectations of patients 3 months after initiation of treatment		3 months after initiation of treatment
Secondary	Describe priorities and expectations of patients, at 6 months after initiation of treatment		6 months after initiation of treatment
Secondary	Describe priorities and expectations of patients, at 12 months after initiation of treatment		12 months after initiation of treatment
Secondary	Describe 3 months after initiation of treatment, the rate of stable patients in their priorities		3 months after initiation of treatment
Secondary	Describe 6 months after initiation of treatment, the rate of stable patients in their priorities		6 months after initiation of treatment
Secondary	Describe 12 months after initiation of treatment, the rate of stable patients in their priorities		12 months after initiation of treatment
Secondary	Overall survival, according to priorities changing or not		3 months after initiation of treatment
Secondary	Compare priorities of older subjects compared to younger patients or physician's priorities		3 months after initiation of treatment