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Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer (APAPI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01780064
First received: January 29, 2013
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

Condition Intervention
Breast Cancer
Behavioral: interviews with a psychologist
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work [ Time Frame: At 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison between the two modes of care, social inequalities and calculating the cost / benefit ratio of the two modes of care [ Time Frame: At 24 months ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard group
routine monitoring with questionnaires
Behavioral: Questionnaires
Questionnaires
Active Comparator: Interviews with psychologist
Patients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires
Behavioral: interviews with a psychologist
interviews with a psychologist
Behavioral: Questionnaires
Questionnaires

Detailed Description:

For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).

In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥ 18 with work at the time of diagnosis
  • Presenting a unilateral breast cancer exclusively local extension
  • Having received surgery
  • Reporting of adjuvant chemotherapy (+ / - trastuzumab)
  • Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
  • In work at the time of diagnosis (employees, traders and professionals)
  • Patient affiliated to a social security scheme
  • Consent signed by the patient before the implementation of any specific procedure to study

Exclusion Criteria:

  • Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
  • Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
  • Recognition previous ALD (due to another disease)
  • Patient under guardianship
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780064

Locations
France
Centre Marie Curie
Arras, France, 62000
Centre Pierre Curie
Beuvry, France, 62880
Centre Léonard de Vinci
Dechy, France, 59187
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Valenciennes, France, 59300
Nouvelle Clinique des Dentellières
Valenciennes, France, 59300
Hôpital Privé de Villeneuve d'Ascq
Villeneuve d'Ascq, France, 59657
Sponsors and Collaborators
Centre Oscar Lambret
University Hospital, Lille
Investigators
Study Director: Sophie FANTONI, MD, PhD CHRU / Université Lille 2
Study Director: Jacques BONNETERRE, MD, PhD Centre Oscar Lambret
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01780064     History of Changes
Other Study ID Numbers: APAPI-1202 
Study First Received: January 29, 2013
Last Updated: July 28, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 27, 2016