Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Information from CDC website Narratives about CRCS written by others Peer social support among study participants

Information + Narratives + Support Group

Information from CDC website on colon cancer screening.

Information Only

Kevin Hwang, MD

To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.

Participants in the control group will view standard online information about colon cancer screening. Participants in the intervention group will view the same information and also will be invited to sign on to the online website and interact with peer supporters at their convenience. They will have 6 months to communicate with peer supporters. Peer supporters are encouraged to address comments and concerns of the study participants.

About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.

The study will also include 15 previously identified peer supporters.

Recruitment: Administrators of the SparkPeople.com weight loss community will send study recruitment emails to members at least 50 years of age. Interested individuals will pass an eligibility screening and provide informed consent.

Online Programs to Promote Colon Cancer Screening

Feasibility of recruitment, randomization, intervention delivery, retention, and assessment of colon cancer screening status

The University of Texas Health Science Center, Houston

Assistant Professor - Internal Medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Control patients will be sent a pamphlet about breast cancer \& its treatment. We will call all patients 2 weeks later and ask if they received the packet. If they didn't, we will send the packet again.

Patients will be surveyed to assess their knowledge about cancer \& its treatment, experience with \& access to health care system, trust, depression, social support \& self-efficacy. A Brief Screening Needs Assessment will be done to ascertain practical, informational or psychosocial needs; based on their responses, an individualized action plan to connect with patient assistance programs will be created for the intervention group. We will ask intervention patients if they connected with any programs in their action plan. For those who didn't connect, we will give their name to an outreach worker. The outreach worker will call patients and identify reasons for not contacting the assistance programs.

Patient Assistance

Information only

Nina A Bickell, MD

The purpose of this study is to determine whether patient-assistance programs as compared with usual care will help women with early stage breast cancer receive appropriate treatments.

Numerous trials proved the efficacy of radiation following breast conserving surgery and systemic therapies to increase disease-free and overall survival among women with early-stage breast cancer. Yet 14%-89% of women do not receive them, especially minority women. Despite lower incidence of the disease, African American women are more likely than white women to die of breast cancer. As we near racial equity in rates of breast cancer screening, disparities in treatment and mortality remain. Efforts to achieve control of breast cancer and reduce racial disparities in mortality will not be fully realized until proven effective treatments are provided to those who can benefit.

Underuse of effective treatments may be caused by patient, physician and system factors. For breast cancer screening, women's lack of access to care; insurance; transportation; beliefs about fatalism and curability, and cancer's effect on partner relationships, all impact mammography rates. For breast cancer treatment, little is known about patient-related reasons for underuse, and less is known about racial differences in such reasons.

Interventions targeted to specific causes are more likely to succeed. For breast cancer screening, patient-centered interventions that successfully raise mammography rates among minority women include lay health workers to raise awareness about and address cultural beliefs and barriers to screening, vouchers to pay for screening and navigators to help women with abnormal screenings obtain needed follow-up. For breast cancer treatment, patient-assistance programs provide practical support such as financial counseling, aid with navigating the complex healthcare system, emotional support, and information about cancer and its treatment. Such programs abound but patients are often unaware of them. While these services may increase the receipt of effective adjuvant therapies, these strategies have not been rigorously tested.

We propose to conduct a randomized controlled trial to evaluate the effectiveness of patient-assistance programs as compared with usual care on receipt of adjuvant therapies among minority and nonminority women with newly operated early-stage breast cancer. During the 24 month trial, we will assess patients' beliefs about cancer and its treatment, and their practical, psychosocial, and informational needs and barriers to care. We will identify and train employees in existing cancer assistance services in order to increase the sustainability of this program beyond the grant-funded cycle. Specifically, we propose:

1. To assess racial differences in early-stage breast cancer patients' experiences, beliefs about and barriers to effective adjuvant treatments;
2. To evaluate the effectiveness of an intervention connecting women with early-stage breast cancer and cancer-related needs to community and hospital-based patient-assistance programs to reduce underuse of effective adjuvant breast cancer treatment overall and in minority populations and to assess its sustainability; and
3. To evaluate whether this patient assistance intervention affects patients' knowledge, attitudes and behaviors

Patient Centered Randomized Controlled Trial

Patient Assistance to Reduce Breast Cancer Disparities

National Cancer Institute (NCI)

Icahn School of Medicine at Mount Sinai

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will be contacted by CHAs by phone one week after giving informed consent and completion of the baseline survey. CHAs will contact participants once a week for up to 10 weeks (a maximum of 10 attempts or until a clinic appointment is made, whichever comes first). Using the TIMS© message library, the CHAs will engage participants in conversations about breast and cervical cancer screening and navigate the participants to overcome any barriers to screening and motivate them to make a clinic appointment. Personal messages from mothers to daughters and vice versa and screening reminder notecards will be sent at 12-months (T3). At 18-months (T4), CHAs will follow-up with navigation group participants who reported completing a mammogram during the navigation process. Screening completion will be measured by self-report and confirmed via medical record check.

Participants will be mailed an informational brochure on mammography and Pap testing one week after enrollment into the study. At 3-months post enrollment, CHAs will conduct a follow-up phone call with each participant to assess mammogram and/or Pap testing completion (primary outcomes). At 12-months (T3) post enrollment, CHAs will contact all control group participants by phone to confirm a scheduled appointment or screening completion. For those who completed a mammogram within the 12 months since enrollment, generic screening reminder notecards will be sent by mail. At 18-months (T4), CHAs will follow-up with those control group participants who reported scheduling a mammogram, Pap smear, or both at the 12-month (T3) time point.

Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card

Navigation

American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card

Jennifer Kue, PhD

Judith Tate, PhD, RN

Cancer is the leading cause of death for Southeast Asian refugee and immigrant (R/I) women; yet they have unacceptably low screening rates. Drawing on successful tailored navigation interventions, the purpose of this study is to compare a culturally congruent, tailored navigation intervention delivered by bilingual and bicultural Community Health Advisors (CHAs) to increase age-appropriate breast and cervical cancer screening completion among intergenerational Southeast Asian R/I women (mother-daughter dyads) with information and reminder only. We will examine the underlying factors that associate with the intervention that influence cancer screening completion. We will also explore the influence of intergenerational exchange of breast and cervical cancer screening information between mothers and daughters. This multi-faceted intervention, combining culturally tailored messages and navigation via CHAs, has high potential for scalability across settings and diseases for hard-to-reach populations. In addition, this study focuses on breast and cervical cancer screening jointly potentially increasing the public health impact.

Cancer is the leading cause of death for Southeast Asian refugee and immigrant women. Cambodian, Lao, and Vietnamese (hereafter referred to as SEAR/I) women have disproportionately high incidence rates of breast and cervical cancers. Breast cancer incidence increased significantly for all Asians from 1988 to 2013, but the largest increase was in SEAR/I women (APC=2.5, 95% CI 0.8, 4.2). Over the past two decades, SEAR/I women experienced significant increases in breast cancer incidence across age groups compared to other Asian and White women. Lao and Cambodian women are 2.5 times and Vietnamese women are 40% more likely to be diagnosed with cervical cancer than are White women. Despite evidence that regular screening through mammography and Pap testing reduces breast and cervical cancer mortality, SEAR/I women continue to have strikingly low rates of screening (75.4% for Pap tests and 64.1% for mammography), well below the Healthy People 2020 target of 93% and 81.1%, respectively. Drawing on successful tailored navigation interventions, the purpose of this study is to test the efficacy of a culturally-relevant, tailored navigation intervention delivered through bilingual and bicultural Community Health Advisors (CHAs) for intergenerational SEAR/I women (mother-daughter dyads). Ethnically matched CHAs will use the tested Tailored Intervention Messaging System (TIMS©) to educate and navigate participants from the community to health clinic to complete mammography and/or Pap testing.

Our specific aims are to:

AIM 1: Test the efficacy of tailored navigation intervention delivered by SEA community health advisors (CHA+TN) to increase age-appropriate breast and cervical cancer screening completion compared to an information and reminder only control among intergenerational SEAR/I dyads.

H1: The intervention group (CHA+TN) will have significantly higher age-appropriate breast and cervical cancer screening rates compared with the control group (information + reminder only).

AIM 2: Examine the underlying mechanisms (both mediating and moderating factors) associated with the intervention (CHA+TN) that influence breast and cervical cancer screening completion.

Exploratory AIM 3: Explore in greater detail the influence of intergenerational exchange of information between mothers and daughters related to breast and cervical cancer screening.

Intervention group- Tailored Navigation Delivered by Community Health Advisor (CHA+TN)

Control Group- Information and Reminder Only

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Online Programs to Promote Colon Cancer Screening	NCT01411826	Colon Cancer Sc...	Information + N... Information Onl...	50 Years - 75 Years	The University of Texas Health Science Center, Houston
Online Programs to Promote Colon Cancer Screening	NCT01411826	Colon Cancer Sc...	Information + N... Information Onl...	50 Years - 75 Years	The University of Texas Health Science Center, Houston
Patient Centered Randomized Controlled Trial	NCT00233077	Early-Stage Bre...	Patient Assista... Information onl...	18 Years -	Icahn School of Medicine at Mount Sinai
Southeast Asian Women's Health Project	NCT04086771	Breast Cancer Cervical Cancer	Navigation Information onl...	21 Years -	Ohio State University

Spots Global Cancer Trial Database for information only