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NCT Number: NCT02821793

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Consultation, evaluation questionnaire

Other

Consultation, evaluation questionnaire

Geriatric consultation, evaluation questionnaire

Other

Geriatric consultation, evaluation questionnaire

Primary outcomes

  1. Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation

    Time frame: 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.

  2. Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment

    Time frame: 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 outcomes

  1. Expectations of Patients at Initiation of Treatment

    Time frame: 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

  2. Expectations of Patients 3 Months After Initiation of Treatment

    Time frame: 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

  3. Stability of Patients in Their Priorities at 3 Months

    Time frame: 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

  4. 1-year Overall Survival

    Time frame: 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

  5. Agreement Rate for Prioritization of Expectations Between Patients and Physicians

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • AG2R La Mondiale
  • Fondation Université de Bordeaux

Registry information

Official study title

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

Acronym: PRIORITY

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Jul 4, 2016
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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