- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
New Jersey
-
Englishtown, New Jersey, Forenede Stater, 07726
- Practicing physician in New Jersey
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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.
Andre navne:
|
Andet: 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: 2-4 years
|
2-4 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Long term disease free survival
Tidsramme: 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Prem A Nandiwada, MD, Raritan Bay Medical Center
- Studieleder: Sarat Babu, MD, St. Peter's Hospital
- Studiestol: Ratna Grewal, MD, American Scitech International-eCRO
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ASI-QOLII0608
- ASI-QOL8655
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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