Needs Assessment After Cancer in Patients Treated for Breast Cancer

NCT ID: NCT03902964

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-02-01

Brief Summary

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observational monocentric study

Detailed Description

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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.

Conditions

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Breast Neoplasm Female Quality of Life Fear Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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women treated for breast cancer in 2017 (cohort A)

all patients who completed breast cancer treatment between January 1 and May 31, 2017. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random

No interventions assigned to this group

women treated for breast cancer in 2015 (cohorte B)

all patients who completed breast cancer treatment between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Jean-Godinot

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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stephanie SERVAGI VERNAT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Jean-Godinot

Locations

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Institut Jean Godinot

Reims, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02191-54

Identifier Type: -

Identifier Source: org_study_id

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