Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer
- Conditions
- Kidney CancerLymphomaLung CancerProstate CancerSarcomaBreast CancerOvarian CancerColorectal 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
- 
Male or female: - Age ≥ 70 years
- Aged 18-69 years (case population)
 
- 
ECOG / performance status 0-3 (WHO). 
- 
First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination): - Neo-adjuvant setting,
- Adjuvant setting: previous neo-adjuvant treatment is allowed,
- Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,
 
- 
Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive). 
- 
Life expectancy of more than 3 months. 
- 
Patients potentially compliant with the rules of the follow-up study. 
- 
Patients affiliated to a social security scheme. 
- 
Patients who received clear information from the investigator on the study and had not refused to participate. 
- 
Exclusive surgery treatment. 
- 
Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy). 
- 
Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion: - Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,
- Adjuvant setting: previous line(s) of adjuvant medical treatment,
- Metastatic setting: previous line(s) of metastatic medical treatment,
 
- 
Supportive care without specific medical treatment 
- 
Previous or ongoing cancer under treatment at the time of inclusion. 
- 
Patient already included in this study 
- 
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
- Name - Time - Method - Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation - Day 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 Treatment - 3 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
- Name - Time - Method - Expectations of Patients at Initiation of Treatment - Day 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 Treatment - 3 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 Months - 3 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 Survival - From 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 Physicians - Day 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
