Quality-of-Life Assessment for Carcinoma in Situ

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Carcinoma in Situ+9 More
Quality-of-Life Assessment - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether an electronic health (eHealth) support program called PACK Health may improve quality of life, decrease hospital admissions and improve overall health for individuals with newly diagnosed breast cancer.

See full description

Eligible Conditions

  • Carcinoma in Situ
  • Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Breast Ductal Carcinoma In Situ
  • Invasive Breast Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome and 1 secondary outcome in patients with Carcinoma in Situ. Measurement will happen over the course of From day 1 to day 180.

Day 180
Rate of emergency room visits and hospital admissions
Up to 6 months
Patient reported outcomes on global physical and mental health

Trial Safety

Trial Design

2 Treatment Groups

GROUP II (standard of care)
1 of 2
GROUP I (PACK Health program)
1 of 2
Active Control
Experimental Treatment

This trial requires 545 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

GROUP I (PACK Health program)Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months.
GROUP II (standard of care)Patients receive standard of care support services over 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive Care
2013
Completed Phase 2
~720

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Carcinoma in Situ or one of the other 9 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 years and older
Able to read, speak and consent in English.
First time diagnosis of invasive breast cancer
Ductal carcinoma in situ (DCIS)
Recurrent breast cancer off all therapy prior to recurrence
Currently starting or undergoing active treatment
Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.

Patient Q&A Section

What causes carcinoma, mammary ductal?

"The most common causes of carcinoma, mammary ductal are [increased estrogen receptor α (ERα): estrogen (E2) receptor status (ERα or ERβ) and overexpression of the proto-oncogene HER2/neu] (http://www.ncbi.nlm.nih.gov/books/NBK.fcgi?rid=cis_bibl_3.5.3.30.1). Breast density has a relationship to HER2/neu(rs11899360) (http://genetics.humc.u-psud.fr/humc/genetic-path/path_her2/humc_her2." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, mammary ductal?

"Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) involve breast tenderness, lumps or masses, nipple discharge, altered skin colour, and changes in shape to the breast. The presence of one of these symptoms, or any combination of symptoms, increases the risk of breast cancer to 4.9 fold over the general population." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, mammary ductal a year in the United States?

"The American Cancer Society's estimate of 35,740 new cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in 2016 is consistent with the number of new cases previously calculated based on breast cancer rates observed in the US in 2010. Estimates of new cases of breast cancer based on rates of breast cancer in 2010 suggest that about 15,000 new cancers will occur in the United States in 2016. This suggests that about 75,000 new cancers will be diagnosed in the United States in 2016." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, mammary ductal?

"Mammary ductal carcinomas occur most commonly in postmenopausal women. A substantial proportion have metastases and in most cases have advanced-stage disease. Radical mastectomy without axillary dissection is typically undertaken and often followed by adjuvant chemotherapy. The adjuvant chemotherapy usually includes anthracyclines." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, mammary ductal?

"Cancer, mammary ductal is a condition that mostly affects women between age 60 and 90. This condition is associated with the development of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) later in life and is caused when cells from a benign lesion or tumor develop uncontrollable cell growth. The most common of all breast cancer is carcinoma, mammary ductal. Breast cancer is one of the most effective cancer treatments, even when it is discovered at an early stage. Copyright rights © 2015 Medical Publishers International." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, mammary ductal be cured?

"The authors have analyzed the treatment history of patients who present with mammary carcinoma to the authors' institution, and have determined that (1) most patients did not receive optimal therapy but had some form of treatment, (2) most patients had good cosmetic results after surgery, and (3) the number of patients with residual disease who received chemotherapy was small, and the number of patients who had failed or lost residual disease was also small when compared with the number of patients with residual disease who received chemotherapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, mammary ductal?

"A small percentage of patients who have carcinoma, mammary ductal and are not eligible for clinical trial would be appropriate candidates for treatment by clinical trial. Although the probability of treatment success may be low, the likelihood that not every patient with carcinoma in situ or carcinoma with microinvasion will progress to invasive carcinoma may be increased with early screening and treatment by clinical trial. Clinical trials involving long-term follow-up might be appropriate for patients who are candidates for treatment of in situ carcinoma by surgical resection." - Anonymous Online Contributor

Unverified Answer

Is quality-of-life assessment safe for people?

"Most people with operable breast, skin and breast cancer can engage in quality-of-life assessment. If asked to complete specific self-report items the data obtained appear comparable to the data obtained by a health professional observer (health care provider)." - Anonymous Online Contributor

Unverified Answer

How does quality-of-life assessment work?

"Quality-of-life assessments were frequently reported using PQI, but other sources of assessments appeared more often. This would indicate that quality of life assessments are not being routinely used in practice, particularly in primary care settings." - Anonymous Online Contributor

Unverified Answer

What does quality-of-life assessment usually treat?

"In a recent study, findings of our study indicate that QoL can be used to characterize the course of breast cancer and to identify patients at risk of developing complications due to surgery, chemotherapy, and endocrine therapy. In particular, we demonstrated that quality of life correlates with clinical symptomatology in patients suffering from breast cancer." - Anonymous Online Contributor

Unverified Answer

Does quality-of-life assessment improve quality of life for those with carcinoma, mammary ductal?

"Patients with carcinoma (C) have markedly different levels of health-related quality of life (HRQOL) than those with benign breast disease (BI). The significant differences between C and BI in HRQOL scores suggest that patients should be evaluated separately before inclusion in clinical studies. Furthermore, HRQOL assessment should be an integral part of patient selection and quality-of life outcomes should be routinely measured." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, mammary ductal?

"Based on these findings, we recommend that the use of definitive radiation therapy in carcinoma, ductal, should be considered if a pathological evaluation confirms the presence of invasive disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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