Breast CarcinomaPhase 2NCT00712621
Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination
A Phase 2 study testing Counseling and Written materials in people with Breast Carcinoma, run by American Scitech International at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Counseling and Written materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 45Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Practicing physician in New Jersey
Englishtown, New Jersey, 07726
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Carcinoma
- Being tested
- Counseling, Written materials
- Keywords
- Genetics Home Reference related topics, breast cancer, breast cancer related to depression, Condition, Stage I-IV Carcinoma of Breast
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Also called Lifestyle Counseling
- 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
Written materialsBehavioural
Also called Quality of Life
- Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.
| Study group | Role | What they receive |
|---|---|---|
| I | Other | 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. Receives: Behavioral: Written materials |
| II | Other | 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. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-4 years
Secondary outcomes (1)
Long term disease free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Scitech International
- Sponsor type
- University, hospital or other
- Investigators
- Prem A Nandiwada, MD, Principal investigator, Raritan Bay Medical CenterRatna Grewal, MD, Study chair, American Scitech International-eCROSarat Babu, MD, Study director, St. Peter's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712621
- Sponsor's protocol ID
- ASI-QOLII0608
- Other IDs
- ASI-QOL8655
- Status last verified
- Nov 2009
- First submitted
- 18 Jun 2008
- Last updated
- 24 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00712621
- Acronym / sponsor ID
- ASI-QOLII0608
- Conditions
- Breast Carcinoma
- Keywords
- Genetics Home Reference related topics, breast cancer, breast cancer related to depression, Condition, Stage I-IV Carcinoma of Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- American Scitech InternationalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Other | Behavioral: Written materialsOUTLINE: 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. |
| II | Other | Behavioral: CounselingOUTLINE: 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. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Breast cancer patients
- 25 to 85 years old
- 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.
- 25 to 49 vs 50 to 85
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Lifestyle Counseling• 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 | Behavioural | II |
| Written materialsAlso: Quality of Life• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study. | Behavioural | I |
Primary outcome
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
Time frame: 2-4 years
1 secondary outcome
Long term disease free survival
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prem A Nandiwada, MD principal investigator
Raritan Bay Medical Center
Ratna Grewal, MD study chair
American Scitech International-eCRO
Sarat Babu, MD study director
St. Peter's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counseling and Written materials in people with Breast Carcinoma, run by American Scitech International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2009.