Sup Sta B_13ZC

Supporting Statement: Part B

Case Studies to Explore Interventions that Support, Build, and Provide Legacy Awareness for Young Breast Cancer Survivors

Supported by:

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Public Health Service

Department of Health and Human Services

December 18, 2013

Government Project Officer:

Temeika L. Fairley, PhD

Health Scientist

Designated Federal Officer, ACBCYW

Office of Program and Policy Information

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Hwy, NE MS K52

Atlanta GA 30341

OFFICE: 770-488-4518

FAX: 770-488-4760

Table of Contents

Part B: Collection of Information Employing Statistical Methods

B1. Respondent Universe and Sampling Methods

B2. Procedures for Collection of Information

B3. Methods to Maximize Response Rates and Deal with Nonresponse

B4. Tests of Procedures or Methods to be Undertaken

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Attachments

1a Authorizing Legislation: Young Women’s Breast Health Education and Awareness Requires Learning Young Act of 2009

1b Authorizing Legisation: Public Health Service Act, Research and Investigation

2 Federal Register Notice

3 Case Study Framework

4 Site Selection Matrix

5 Similarities and Differences Across Case Types

6a Data Collector Non-disclosure Agreement

6b Introductory Letter

6c Introductory Email

6d Site Visit Preparation Call

6e Worksheet for Identifying Site Visit Interviewees

6f Worksheet for Scheduling Site Visit Interviews

7a Document Review Form

7b Observation Form

8 Interview Guide Matrix

9 Informed Consent

10a In-depth Interview Guide for Program Directors/Principal Investigators (Organizations that receive CDC DP11-1111 funding)

10b In-depth Interivew Guide for Program Managers (Organizations that receive CDC DP11-1111 funding)

10c In-depth Interview Guide for Program Staff Members (Organizations that receive CDC DP11-1111 funding)

10d In-depth Interview Guide for Program Partners (Organizations that receive CDC DP11-1111 funding)

11a In-depth InterviewGuide for Program Directors/Principal Investigators (Organizations that do not receive CDC DP11-1111 funding)

11b In-depth Interview Guide for Program Managers (Organizations that do not receive CDC DP11-1111 funding)

11c In-depth Interview Guide for Program Staff Members (Organizations that do not receive CDC DP11-1111 funding)

11d In-depth Interview Guide for Program Partners (Organizations that do not receive CDC DP11-1111 funding)

12 IRB Approval Letter

Case Studies to Explore Interventions that Support, Build, and Provide Legacy Awareness for Young Breast Cancer Survivors

Part B: Collection of Information Employing Statistical Methods

B1. Respondent Universe and Sampling Methods

CDC will conduct up to 12 case studies with organizations that implement initiatives and/or interventions related to the development, provision, or promotion of educational resources and/or support services for young breast cancer survivors (YBCS). Organizations involved in YBCS-targeted interventions, include but are not limited to: universities and academic centers, hospitals and cancer centers, non-profit organizations, and state health departments.

Using purposeful sampling, 12 organizations (cases) will be selected as potential case study participants using the following defined criteria: (1) organization’s experience with developing, promoting, and/or evaluating YBCS interventions; (2) the context for which these interventions operate; and (3) the factors that affect the development, implementation and/or evaluation of YBCS interventions. CDC also intends to explore the benefit and value of DP11-1111 cooperative agreement with grantees.

Preliminary selection criteria generated by the project team were focused on program and intervention characteristics, and include the following: type of organization (DP11-1111 cooperative agreement recipient; other organization not funded through DP11-1111 with YBCS-focused interventions); target population (YBCS, families and/or caregivers, healthcare providers, underserved populations); the intervention setting (clinical, non-clinical); the communication channels used to either promote or implement the YBCS intervention (mass media, small media, social media, interpersonal communication); and strategies used as a part of the YBCS intervention (educational resources, support services). Within these categories, the project team aimed for a mixture of sites that included variability across these categories. For the purpose of this study, operational definitions were created for all selection criteria. Definitions include:

Selection Criteria	Operational Definition
Type of Organization
DP11-1111		Those organizations that are a part of the DP11-1111 cooperative agreement
Unfunded organization		Those organizations that are not a part of the DP11-1111 cooperative agreement
Target Population
Young Breast Cancer Survivors (YBCS)	Women diagnosed with breast cancer under the age of 45
Families and/or Caregivers	Individuals who are responsible for caring for YBCS (e.g., family members, friends, coworkers)
Healthcare Providers	Health professionals who provide health services that target YBCS (e.g., physicians, physician assistants, nurses, medical assistants)
Underserved Populations	Individuals belonging to groups that have not received precedent in medical research and service. These groups include racial/ethnic minorities, those of lower socioeconomic statuses, and recent immigrants
Intervention Setting
Clinical Setting	YBCS interventions that fit one or more of the following criteria with respect to the majority of their intervention components— Housed within a clinical setting (e.g., hospitals/hospital systems, health clinics) Provide educational resources and/or support services to participants within a clinical setting Utilize a clinical setting as the primary source of recruitment of intervention participants
Non-Clinical Setting	YBCS interventions that fit one or more of the following criteria with respect to the majority of their intervention components— Housed within a non-clinical setting (e.g., not-for-profit organizations, community-based organizations, government organizations, web-based initiatives) Provide educational resources and/or support services to participants within a non-clinical setting Utilize a non-clinical setting as the primary source of recruitment of intervention participants
Communication Channels
Mass Media	YBCS interventions that utilize mass media channels (i.e. newspapers, television, radio, billboards, magazines) to communicate educational and/or motivational information to large and relatively undifferentiated audiences.
Small Media	YBCS interventions that utilize small media channels (e.g., videos, letters, brochures, newsletters) to provide information tailored to specific individuals or general audiences.
Social Media	YBCS interventions that utilize online tools (i.e. Facebook, Twitter, blogs) to share content relevant to YBCS, caregivers, and/or healthcare providers.
Interpersonal Communication	YBCS interventions that communicate primarily via direct interaction between one or more individuals (i.e. one-on-one interaction, group education)
Intervention Strategies
Educational Resources	Resources intended to enhance patient and/or provider knowledge of health behaviors and other strategies for reducing the risk of recurrences, development of new malignancies, chronic disease onset, and/or improving overall health and quality of life for young women with breast cancer.
Support Services	Structured services intended to provide support to young women with breast cancer (i.e. case management and/or patient navigation assistance).

Using the selection criteria, the evaluation team created the following list of potential organizations to serve as respondents for this exploratory study:

• John C. Lincoln Health Foundation (DP11-1111 funded)

• Living Beyond Breast Cancer (LBBC) (DP11-1111 funded)

• Louisiana State University and Health Services Center (DP11-1111 funded)

• Sharsheret (DP11-1111 funded)

• University of California at Los Angeles (DP11-1111 funded)

• University of North Carolina at Chapel Hill (DP11-1111 funded)

• Washington University at St. Louis (DP11-1111 funded)

• Knight Cancer Institute Adolescent and Young Adult Oncology Program at Oregon Health and Science University

• Program for Young Women with Breast Cancer at Dana Farber

• Tigerlily Foundation

• University of Colorado, Denver

• Young Survival Coalition

In order to avoid duplication of data collection efforts (particularly among DP11-1111 grantees), this information collection will focus on assessing how grantees and nonfunded organizations plan, implement, and evaluate YBCS interventions; the context for which these interventions are implemented; and the factors that affect implementation.

B2. Procedures for Collection of Information

Upon receiving OMB approval, CDC will send an Introductory Letter and Introductory Email to each organization to provide them with information about the case studies and confirm their interest and willingness to participate (Attachment 6b and 6c). Within one month, the contractor will schedule a conference call with each site via email and use the Script for Scheduling Site Visits to contact each organization and plan their respective case study site visit, including identifying appropriate staff members to interview and scheduling dates, times, and locations for each interview (Attachments 6d, 6e, and 6f). At this time, CDC will also request key program documents in electronic format in order to conduct a document review prior to the site visit (Attachment 7a).

Each case study will include one site visit to the respective organization, with a total of up to 12 case studies conducted. Case studies will be conducted at one point in time. Each site visit will include in-depth interviews with several respondent types, including: Principal Investigators/Program Directors (1 per site), Program Managers (1 per site), Program Staff Members (up to 5 per site), and Program Partners (up to 3 per site), which could total up to 10 respondents per site. In addition, site visit will include on-site observation of key programmatic activities, such as key program meetings and intervention activities. In addition, ICF site visit staff will record on-site observations of key programmatic activities (Attachment 7b). These activities will provide important context for interpreting interview findings.

Respondents will be asked to give verbal consent to participate and for the interview team to audio record the interview for transcription purposes. The audio tapes will be destroyed after interview transcripts have been created for data analysis purposes.

B3. Methods to Maximize Response Rates and Deal with Nonresponse

Case studies will include the seven organizations currently participating in the DP11-1111 cooperative agreement, as well as five additional organizations providing educational resources and support services to YBCS. In the event that one or more is unable or unwilling to participate, that organization will not be substituted with an alternate organization and the total number of case studies will be decreased. Participation is voluntary for the on-site interviews and on-site observations.

B4. Tests of Procedures or Methods to be Undertaken

CDC staff and contractors, who comprise the study team, were involved in the development, review, and approval of case study documents.

B5. Individuals Consulted on Statistical Aspects and Individual Collecting and/or Analyzing Data

Data collection instruments will be reviewed by three CDC staff with expertise in breast cancer survivorship issues and/or case study methodology.

Temeika L. Fairley

Health Scientist

Designated Federal Officer, ACBCYW

Office of Program and Policy Information

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Hwy, NE MS K52

Atlanta, GA 30341

Phone: 770.488.4518

Email: [email protected]

Angela Moore

Centers for Disease Control and Prevention

Division of Cancer Prevention and Control

4770 Buford Highway, NE

Atlanta, GA 30341

Phone: 770.488.3094

Email: [email protected]

Tiffani Mulder

Centers for Disease Control and Prevention

Division of Cancer Prevention and Control

4770 Buford Highway, NE

Atlanta, GA 30341

770.488.3289

[email protected]

Information will be collected and analyzed by CDC’s contractor, ICF International.

Sarah O’Dell

Project Manager

ICF International

3 Corporate Square, Suite 370

Atlanta, GA 30307

404.321.3211

[email protected]

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