Breast Cancer Clinical Trial
Official title:
Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
RATIONALE: Gathering information from patients who received treatment for metastatic cancer
while participating in a phase II or phase III randomized clinical trial and from patients
receiving standard treatment off-trial may help doctors learn more about the psychological
and emotional results of being in a clinical trial.
PURPOSE: This clinical trial is comparing the psychological and emotional impact of
participating in a randomized clinical trial with the impact of standard treatment in
patients with metastatic cancer.
OBJECTIVES:
Primary
- To compare the psychological and emotional consequences in patients who underwent
first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic
disease while participating in a phase II or III randomized clinical trial vs patients
who underwent standard first-line treatment off-trial.
Secondary
- To measure and compare the temporal variation of psychological and emotional
consequences during and after completion of or stopping of treatment.
- To measure and compare the degree of knowledge of the implications of participating in
a clinical study vs the benefits of standard off-trial treatment and evaluate the
impact on psychological and emotional experience.
- To evaluate the relationship between the use of adjustment strategies and emotional
regulation and psychological and emotional experiences in both of these situations.
OUTLINE: This is a multicenter study.
Patients complete four questionnaires, including assessment of symptoms of anxiety and
depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of
emotional behavior (ERQ), during their first course of treatment, after the first evaluation
of treatment effectiveness, and one week after completion of treatment. During their first
evaluation, patients also complete a questionnaire on the modalities of randomized clinical
trials and their impact on care (ICEC-R).
;
N/A
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |