- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00712621
Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination
Phase II Two Arm Randomized Controlled Clinical Trial to Study Quality of Life and Survival of Breast Cancer Patients After Completion of Chemotherapy or Radiation Therapy or Surgery or Any Combination Therapy in Stage I to IV Carcinoma
Rationale: Determining quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy.
Intervention includes supportive care in terms of psychological support and moral boosting efforts by counseling breast cancer survivors which may enhance the well-being and quality of life of women who are treated with chemotherapy or radiation therapy or surgical procedures or any given combination therapy.
PURPOSE: Randomized clinical trial study to compare the effectiveness of support system and counseling of breast cancer survivors on the well-being of women, who have completed various modes of treatment of breast cancer with the subjects who have no support system.
Study Type: Quality of life and survival
Study Design: Two arm randomized controlled clinical trial to study quality of life and survival of breast cancer patients after completion of chemotherapy or radiation therapy or surgery or any combination therapy. The stages from I to IV (metastases to other sites of the body) are included.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- Determine the quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy in both Arms.
- Determine the effect of providing standard written materials in Arm I.
- Determine the effect of psychological support and moral boosting efforts by counseling breast cancer survivors which may enhance the well-being and quality of life of women who are treated with chemotherapy or radiation therapy or surgical procedures or any combination therapy in Arm II.
- Determine the effect of socioeconomic status on all available demographic area which is not a criteria for exclusion in both Arms.
- Determine psychosocial and mental state to measure wellness and good quality of life in both Arms.
- Determine the periodic medical care for related or unrelated problems of the disease which have a positive impact on the survival and quality of life in both Arms.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
New Jersey
-
Englishtown, New Jersey, Stati Uniti, 07726
- Practicing physician in New Jersey
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Breast cancer patients
- 25 to 85 years old
DISEASE CHARACTERISTICS:
- Received prior definitive treatment for stage I-IV breast cancer with or without adjuvant chemotherapy or radiation therapy or surgical therapy or any combination therapy.
- 3 to 18 months since completion therapy.
PATIENT CHARACTERISTICS:
Age:
- 25 to 49 vs 50 to 85
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- CBC in normal range:
- Hemoglobin - 10 g/dl
- Blood Glucose is twofold above the normal range
Hepatic:
- Hepatic profile is twofold above the normal range:
- AST/ALT
- Bilirubin,total
- Protein (Albumin, Globulin)
Renal:
- Renal tests are twofold above the normal range:
- Creatinine clearance 24 hours
- BUN
- Creatinine level
Other:
- No current psychiatric diagnosis
- Mini Mental Status Examination
- No signs and symptoms MDD
- Anxiety disorder
- Post Traumatic Syndrome Disorder
Status of Therapy:
Chemotherapy:
- Completed
Endocrine therapy:
- Completed
Radiotherapy:
- Completed
Surgery:
- Completed at least three months before the start of the study
Exclusion Criteria:
- Age below 25 and above 85
- Subject with breast carcinoma in therapy
- Any current mental illness
- Hepatic enzymes are more than twofold from the normal range
- Renal impairment is more than twofold from the normal range
- Hemoglobin is less than 10 g/dl
- CBC results are below normal range
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: I
OUTLINE: This is a randomized, multicenter study. Patients are selected according to age ( 25 to 49 vs 50 to 85), time since initial completion of therapy (3 to 18 months), and are separated in two groups. Arm I: Quality of life is assessed at baseline and at 3 and 6 months. |
• Arm I: Patients receive the support by providing existing resources.
Patients receive standard written materials from the counseling group after enrolling in the study.
Altri nomi:
|
|
Altro: II
OUTLINE: This is a randomized, multicenter study. Patients are selected according to age ( 25 to 49 vs 50 to 85), time since initial completion of therapy (3 to 18 months), and are separated in two groups. Arm II: Quality of life is assessed at baseline and at 3 and 6 months. |
• Arm II: Patients receive audio visual aids and weekly counseling sessions by the expert counselors and breast cancer survivors over 8 weeks for a total of 8-16 sessions.
Patients receive written materials from the counseling group after the completion of the sessions
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Procedure: Psychological assessment and discussion on social & economic issues and medical problems related or unrelated to the therapy; quality-of-life assessment; long term survival
Lasso di tempo: 2-4 years
|
2-4 years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Long term disease free survival
Lasso di tempo: 5 years
|
5 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Prem A Nandiwada, MD, Raritan Bay Medical Center
- Direttore dello studio: Sarat Babu, MD, St. Peter's Hospital
- Cattedra di studio: Ratna Grewal, MD, American Scitech International-eCRO
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ASI-QOLII0608
- ASI-QOL8655
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .