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OpenTrials
Completed

NCT Number: NCT03902964

Needs Assessment After Cancer in Patients Treated for Breast Cancer

observational monocentric study

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut Jean Godinot

Reims, 51100, France

About this study

observational monocentric study

Primary objective :

Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.

Secondary objective :

  • Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.
  • Compare the need for supportive care between the end of treatment and 2 years after.
  • Assess needs after cancer according to the stage of the disease
  • Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.
  • Assess needs after cancer according to age and socio-professional category.

Schedule :

The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.

Exclusion criteria

Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.

Treatment and study plan

Primary outcomes

  1. Post-cancer needs analysis

    Time frame: 2 years

    Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts

Sponsors and collaborators

Lead sponsor

Institut Jean-Godinot

Other

Registry information

Acronym: EACE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Apr 4, 2019

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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