Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling | Behavioral | — | UNRESOLVED |
| Written materials | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- I
- description
- 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.
- interventionNames
- Behavioral: Written materials
- type
- OTHER
- label
- II
- description
- 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.
- interventionNames
- Behavioral: Counseling
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available