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Clinical Trials/NCT01331629
NCT01331629
Completed
Phase 2

Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer

Centre Francois Baclesse6 sites in 1 country322 target enrollmentJuly 2010
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ConditionsBreast Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre Francois Baclesse
Enrollment
322
Locations
6
Primary Endpoint
evaluate persistent fatigue
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Breast cancer surgery (invasive or in situ) by conservative surgery
  • •Age ≥ 18 years
  • •Indication of adjuvant radiotherapy
  • •Adjuvant chemotherapy allowed
  • •Agreeing to participate in a clinical study
  • •Able to participate in a clinical trial

Exclusion Criteria

  • •Metastatic Breast Cancer
  • •Personal history of breast cancer

Outcomes

Primary Outcomes

evaluate persistent fatigue

Time Frame: up to 12 months after radiotherapy

Estimate the decrease in the proportion of patients with persistent fatigue after one month of radiotherapy in patients receiving an approach from art therapy as a complement to standard care compared to those with care standard alone. Evaluated by auto-questionnary

Secondary Outcomes

  • Evaluate the quality of life patients.(up to 12 months after radiotherapy)
  • Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives(up to 12 months after radiotherapy)
  • Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients(6 months and 12 months after treatment)
  • Evaluate the anxiety of patients(up 12 months after radiotherapy)
  • evaluate the depression of patients(up 12 months after study)
  • Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients(6 months and 1 year after treatment)

Study Sites (6)

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