Neoplasms

All Conditions

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.

Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.

Rinaa S. Punglia, MD, MPH

Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.

Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.

Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.

Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)

Impact of Radiation Therapy on Breast Conservation in DCIS

The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster.

Patient-Centered Outcomes Research Institute

Dana-Farber Cancer Institute

Principal Investigator

This was a retrospective review of data from the SEER and SEER-Medicare registries. There were no adverse events to report because this was not a clinical trial.

Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer

SEER

SEER-Medicare

Data was collected from the Surveillance Epidemiology and End Results database on patients with DCIS between 1990 and 2011.

SEER-Medicaid diagnoses from 1990-2009 linked to Medicare claims through 2010

Total

Age at Secondary Diagnosis

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

1 (lowest)

5 (highest)

Participants' median income levels were assessed using US Census Data. Income data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest socioeconomic status (quintile 1) to highest socioeconomic status (quintile 5).

Number of Participants with Household Income Within Census Data Quintiles

Participants' education levels were assessed using US Census Data. Education data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest education level (quintile 1) to highest education level (quintile 5).

Number of Participants in Education Levels Within Census Data Quintiles

Urban

Rural

Residence

Number of Participants with a Secondary SEER Diagnosis

Ductal carcinoma in situ (DCIS)

Stage I

Stage II-III

Unknown

For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The number of cases who had a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387. Staging in the SEER and SEER-Medicare data registries is consistent with general cancer staging. Higher stages indicate worse outcomes.

The number of cases with a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387.

Number of Participants with Secondary SEER Diagnoses and Staging

Positive

Negative

For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The total number of cases who had ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ER positive or negative. Therefore, the total number of SEER-Medicare cases in the final analysis was 387.

The total number of cases with ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was unclear whether the diagnosis was ER+ or ER-.

Number of Participants with ER Status for Secondary SEER Diagnosis

Ipsilateral

Contralateral

For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with laterality information. The total number of cases who had laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral. Therefore, the total number of SEER-Medicare cases in the final analysis was 387.

The total number of cases with laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral.

Number of Participants with Laterality for Secondary SEER Diagnosis

1990-1995

1996-2000

2001-2005

2006-2011

Year of secondary diagnosis

Interval between diagnoses

Low (HSAs with lowest proportion receiving RT)

Medium

High (HSAs with highest proportion receiving RT)

Regional treatment intensity was measured by using health service areas (HSAs). HSAs were assiged to 1 of 3 clusters based on the observed proportion of radiotherapy used as coded by SEER and SEER-Medicare. The HSAs with the highest proportion of patients receiving radiotherapy were assigned to the high cluster; those with the lowest to the low cluster. This table shows how many people lived in each HSA.

Treatment intensity for primary DCIS

The Charlson comorbidity score is used to predict the risk of death within 1 year of hospitalization for patients with specific comorbid conditions. A high score indicates increased risk.

Data was not collected for the SEER group and the data is no longer available to us.

Charlson comorbidity score

<10 miles

10+ miles

Data was not collected for the SEER group and is no longer available to us.

Distance to nearest radiation facility

Chemotherapy for secondary breast event

MRI in 6 months before secondary breast event

No data set can capture all of the complexity surrounding surgical decision making at the time of a second diagnosis. We did not have information about patient preferences or the clinical characteristics about second breast event.

Rinaa Punglia, MD

Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.

Age at secondary diagnosis: <50

Age at secondary diagnosis:50 to 59

Age at secondary diagnosis: 60 to 69

Age at secondary diagnosis: 70 to 90

Race: White

Race: Black

Race: Other

Hispanic: No

Hispanic: Yes

Median income: Quintile 1 (lowest)

Median income: Quintile 2

Median income: Quintile 3

Median income: Quintile 4

Median income: Quintile 5 (highest)

High school educated, Quintile 1 (lowest)

High school educated, Quintile 2

High school educated, Quintile 3

High school educated, Quintile 4

High school educated, Quintile 5 (highest)

Residence: Urban

Residence: Rural

Secondary SEER Diagnosis: No

Secondary SEER Diagnosis: Yes

Stage of secondary SEER Diagnosis: DCIS

Stage of secondary SEER Diagnosis: Stage I

Stage of secondary SEER Diagnosis: Stage II-III

Stage of secondary SEER Diagnosis: Unknown

ER status of secondary SEER diagnosis: Positive

ER status of secondary SEER diagnosis: Negative

ER status of secondary SEER diagnosis: Unknown

Laterality of secondary SEER diagnosis:Ipsilateral

Laterality of secondary SEER diag.: Contralateral

Year of secondary diag.: 1990-1995

Year of secondary diag.: 1996-2000

Year of secondary diag.: 2001-2005

Year of secondary diag.: 2006-2011

Charlson comorbidity score: 0-1

Charlson comorbidity score: 2+

Distance to nearest radiation facility: <10 mi

Distance to nearest radiation facility: 10+ mi

Chemotherapy for secondary breast event: No

Chemotherapy for secondary breast event: Yes

SEER - Low Treatment Cluster

Medium treatment intensity for primary DCIS

SEER-Medium Treatment Cluster

High treatment intensity for primary DCIS

SEER - High Treatment Cluster

SEER-Medicare - Low Treatment Cluster

SEER-Medicare - Medium Treatment Cluster

SEER Medicare - High Treatment Cluster

Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS

SEER-Medicare diagnoses from 1990-2009 linked to Medicare claims through 2010

Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer

Surveillance Epidemiology and End Results (SEER)-Medicare

Data was collected from the Surveillance Epidemiology and End Results (SEER) database on patients with ductal carcinoma in situ (DCIS) between 1990 and 2011.

Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer

Surveillance Epidemiology and End Results (SEER)

Overall Study

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.

Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.

The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.

Nueva Vida Intervention

Kristi D Graves, Ph.D.

Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.

What is the Nueva Vida Intervention? The "Nueva Vida Intervention: Improving Quality of Life in Latina Breast Cancer Survivors and Their Caregivers" is a randomized controlled trial (RCT) that was co-developed by a Latina breast cancer survivor who is trained as a mental health professional. The program was developed for Nueva Vida, a community-based organization (CBO) in the Washington, DC metropolitan area that serves Latina breast cancer survivors and their families. We are comparing the intervention to the usual services provided at our four partner community-based organizations.

How is the Nueva Vida Intervention Structured? The 8-session psycho-educational quality of life intervention includes group-based skill-building workshops in which Latina survivors and their caregivers are part of concurrently-held but separate groups (survivors in one room; caregivers in another). This separation meets the needs of Latino participants by encouraging them to freely share their experiences and feelings without worrying about upsetting the other person. Five of the eight sessions address core topics: Introduction and The Impact of Cancer on the Family, Stress Management, Improving Communication: Family, Friends, and Providers, Spirituality and Cancer, and Balancing Physical and Emotional Needs.

The remaining three sessions are selected by the intervention participants based on their own needs and interests from the following options: Anger Management, Intimacy after Cancer: Emotional and Sexual, Trauma and Cancer, Role Changes, Understanding Distress and Depression, Myths and Cancer, Including Others in Helping Caregivers, and Putting Our Lives in Order. At the end of the intervention everyone participates in a graduation ceremony.

How does the Nueva Vida Intervention Reflect Latino Values? The Nueva Vida intervention reflects Latino values, including personalismo (warm, personal relationships), familismo (emphasizing the family unit in managing a cancer diagnosis) and framing the sessions as workshops to avoid stigma associated with mental health care.

Where will the Nueva Vida Intervention Study take place? We will evaluate the Nueva Vida Intervention within a multi-site RCT at four community-based organizations in Washington, DC (Nueva Vida), New York, New York (SHARE, Gilda's Club New York City), and San Jose, California (Latinas Contra Cancer).

What is Involved in Study Participation? Latina survivors and their caregivers will be assigned by chance (randomized) to either the Nueva Vida Intervention or to usual care. Survivors and caregivers assigned to usual care can take part in any and all of the services provided at one of the four community-based organizations who are study partners. Both survivors and caregivers will complete informed consent forms and telephone surveys at the beginning of the study, about 4 months later, and again 6 months later. Survivors and caregivers receive gift cards in appreciation of their time for completing the surveys.

Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers

Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning

Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles

Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety

Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression

Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue

Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.

Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment

Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers

Nueva Vida, Inc.

Latinas Contra Cancer

Gilda's Club NYC

SHARE

Georgetown University

Associate Professor

Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.

Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.

Usual Care

Survivors

Caregivers

Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.

Age, Categorical

Race (NIH/OMB)

This measure was administered to Survivors only. 11 items; Range: 10-44; Higher scores = better communication

Satisfaction with Care Experience of Care and Health Outcomes (ECHOS-NHL)

12 items. The CBI-B score is calculated as the sum of all 12 items, range = 12-108. A higher score = higher confidence.

Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)

This scale was administered to Survivors only. 6 items; Range: 1-5; Higher scores = higher general satisfaction with care.

Communication - Patient Satisfaction with Care (PSQ-18 Communication Subscale)

6 items; Sum and then use IRT to standardize the score. Standardized Mean of 50; SD of 10. Range of the raw score = 6 to 30. Reference value for breast cancer survivors T-score is 49.6. A higher score = higher anxiety.

PROMIS Anxiety

6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; Reference value for breast cancer survivors T-Score in Depression is 48.5. A higher score = higher depression

PROMIS Depression

4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; Reference value for breast cancer survivors T-Score for Fatigue is 52.5. A higher score = higher fatigue

PROMIS Fatigue

6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; Reference value for breast cancer survivors T-Score for Physical Functioning is 44.9. A higher score = higher physical functioning

PROMIS Physical Functioning

6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; Reference value for breast cancer survivors T-Score for Satisfaction with Social Roles is 50.7. A higher score = higher satisfaction with social roles

PROMIS Satisfaction With Social Roles

Two participants enrolled in the study but withdrew prior to the baseline interview (thus, N = 130). Baseline analysis was conducted by 1) randomization, and 2) participant type. Data was missing for certain measures; numbers analyzed are adjusted accordingly.

Difficulty tracking all approached and eligible participants in terms of number of individuals who declined the study due to recruitment at multiple community events and community sites.

Kristi Graves, PhD

Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.

Usual Care Survivors

Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.

Usual Care Caregivers

Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.

The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.

Nueva Vida Intervetion Survivors

Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.

The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.

Nueva Vida Intervention Caregivers

Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Radiation Therapy on Breast Conservation in DCIS	NCT02248662	DCIS		21 Years -	Dana-Farber Cancer Institute
Impact of Radiation Therapy on Breast Conservation in DCIS	NCT02248662	DCIS		21 Years -	Dana-Farber Cancer Institute
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers	NCT02222337	Quality of Life Breast Cancer	Nueva Vida Inte...	- 85 Years	Georgetown University
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers	NCT02222337	Quality of Life Breast Cancer	Nueva Vida Inte...	- 85 Years	Georgetown University

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Spots Global Cancer Trial Database for pcori

Every month we try and update this database with for pcori cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pcori cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.