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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
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.

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
Primary Outcome Measures
NameTimeMethod
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment InitiationDay 0 initiation of treatment

Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.

For each expectation, the number and rate of priorization are reported.

Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment3 months after initiation of treatment

Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.

For each expectation, the number and rate of priorization are reported.

Secondary Outcome Measures
NameTimeMethod
Expectations of Patients at Initiation of TreatmentDay 0 initiation of treatment

Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden

Expectations of Patients 3 Months After Initiation of Treatment3 months after initiation of treatment

Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden

Stability of Patients in Their Priorities at 3 Months3 months after initiation of treatment

For each expectation, stability is defined as the prioritization of the expectation at treatment initiation and 3 months after treatment initiation

1-year Overall SurvivalFrom inclusion to the end of study

Overall survival is defined as the time between the date of inclusion and the date of death, whatever the cause.

The rate of overall survival is reported at 1 year

Agreement Rate for Prioritization of Expectations Between Patients and PhysiciansDay 0 initiation of treatment

For each expectation, the agreement rate is defined by the same prioritization or non-prioritization by the patient-physician pairs.

Trial Locations

Locations (1)

Institut Bergonié

🇫🇷

Bordeaux, France

Institut Bergonié
🇫🇷Bordeaux, France

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