Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

Women in the mHealth group will receive text and voice messages, in addition to their habitual care from the health clinic they attend. The messages will remind them to schedule a PAP smear, and will be sent for 1 year following enrollment in the study.

Women in the No mHealth group will not receive any text messages, and will only receive their habitual care from the health clinic they attend.

Text and voice messages sent to study participants reminding them to schedule a PAP smear.

mHealth

Javiera Martínez, MD, MPH

Francis Ciampi, Nurse

Javiera Martinez-Gutierrez, MD, MPH

Carmen Huerta

The purpose of this study is to evaluate the implementation and effectiveness of text messages as a means for improving adherence to cervical cancer screening.

1. Problem Outline, Theoretical Framework and Project Justification

   The problem: Cervical Cancer

   Cervical cancer is a serious public health problem. Worldwide, it is the third leading cause of death of women. An estimated 270,000 women die every year due to cervical cancer, and more than 85% of these deaths take place in developing countries (1).

   Chile´s national cervical cancer program was created in 1987. Since then, and with the systematic implementation of cervical cancer screening through Papanicolau (Pap) smears, cervical cancer mortality rates have dropped significantly (2,3).

   In spite of all efforts, cervical cancer continues to cause the mortality of more than 500 women each year in Chile. Across the nation, only 59 percent of the population is up-to-date with their Pap, a figure that has not changed significantly in the last 10 years (2). In the Metropolitan Region, this percentage is as low as 56 percent. The distribution of cervical cancer, like that of other cancers, follows a pattern of inequality in that women of lowest socioeconomic status are those most affected (4).

   Closing the Gap: Mobile Health (mHealth)

   Mobile technologies have had an exponential increase in the last few years.

   In 2014, the penetration of mobile phones will reach 90% in developing countries compared to 121% in developed countries. (5, 6).

   This same trend can also be seen in access to mobile broadband technologies, which will have an estimated penetration of 32% by the end of 2014.

   The number of internet users worldwide follows this same trend as well. By the end of 2014, there will be more than 3 billion users, with more than 2/3 of these in developing countries.

   According to a survey by the Deputy Minister of Telecommunications in Chile (7), access to a mobile or fixed internet connection was 39.4% by the end of 2009. This increased to over 60% by 2012.

   This coverage is distributed unequally according to socioeconomic class, with more than 81% of penetration in richer homes and less than 30% in poorer strata (21.4% and 9.8% respectively).

   On the other hand, mobile telephones reached more than 90% of homes in 2009, of both rural and urban survey respondents interviewed by the Deputy Minister of Telecommunications. While inequalities remain in this area as well, they are much less profound than with other technologies: the mobile telephone can be found widely distributed in all socioeconomic levels, and varies between 97% in richer strata and 82.8% in poor SES (7).

   By the end of 2013, the percentage of mobile telephone subscribers per 100 inhabitants was almost 40% for mobile phones with a contract and more than 94% for phones with prepaid plans.

   The Solution: Using mobile health technology (mHealth)

   Mobile health (mHealth) has been defined by the WHO (World Health Organization) as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices" (9).

   Given the explosion of the use of these technologies in the world and particularly in developing countries, the potential for mobile health in health issues is huge.

   The overall interest in mobile health is widespread (11). According to the WHO´s report on mHealth in 2011 (9), mobile health strategies exist in at least 75% of the countries that belong to the WHO in each region. 100% of the countries in the Southeast Asian region reported some mobile health initiative at different stages of development, and the Americas region reported that more than 90% of its countries had some form of mobile health initiative (Chile was not included in these statistics).

   According to the World Bank, high-income countries reported more initiatives than low-income countries.

   Some examples of mobile health initiatives in Latin America are the following: Mexico reported a mobile health program called MedicalHome in which a million mobile telephone subscribers have access to health professional support by telephone for $5 per month, which is charged directly to the cell phone account. Columbia reported a program for treatment adherence reminders using voice messages and Peru reported a RCT (Randomized Controlled Trial) that was done to assess treatment adherence using text messaging in patients with HIV/AIDS (9).

   One of the most relevant problems regarding the use of these technologies is that there isn´t sufficient evidence of its effectiveness in prevention (12). Because of this, it is imperative to invest in rigorous and systematic evaluations of these interventions so that they can be applied at the population level.

   While some evidence exists that shows that mobile health is an effective strategy for treatment adherence for prenatal care and those with HIV and TB (13,14,15), the potential use of mobile health technologies in cancer prevention has not been fully explored. Given the widespread existence of mobile telephones in Chile, investigators intend with this study to deliver a simple, replicable, and scalable intervention to improve the rates of morbidity and mortality due to cervical cancer that afflict Chile´s population.
2. Research Questions

1. Do mobile technologies have a preventive benefit in women with greater risk of getting cervical cancer as compared to usual care? 2. In women with greater risk of getting cervical cancer, what are the barriers and facilitators to implementing this kind of technological intervention?

3. Research Hypotheses

1. Null Hypothesis: The proposed intervention does not increase Pap adherence rates in the studied health centers.

   Alternative Hypothesis: The proposed intervention increases Pap adherence rates in the studied health centers.
2. Null Hypothesis: An intervention using mobile technology cannot be feasibly implemented in this population.

Alternative Hypothesis: It is possible to implement an intervention using mobile technology in this population.

4. Study Objectives General Objective: Evaluate the implementation and effectiveness of a mobile health intervention to increase cervical cancer screening adherence.

Specific Objectives:

1. Evaluate the effect that a text message intervention has on Pap adherence rates.
2. Evaluate the implementation and usability of a cellphone mobile health intervention in three health centers of the Southeast Metropolitan Health District of Santiago.

5. Methodology Design:

1. Quantitative phase:

   1. Target Population:

      Target population will be women between 25 and 64 years of age who use cell phones and do not have an up-to-date Pap test (no Pap in the last three years). They must also be registered at one of the following health clinics: CESFAM (Centro de Salud Familiar) El Roble or CESFAM Juan Pablo II.

      A randomized controlled trial will be carried out to evaluate the effectiveness of text message intervention in improving Pap adherence. Socio-demographic variables associated with its effectiveness will also be analyzed.

      Selection methodology: Using the database of medical records in each clinic, women will be identified that meet the inclusion criteria. They will be invited to participate in the study, and if they choose to accept, informed consent will be obtained.

      Before randomization, the participants will be asked to complete a questionnaire with simple demographic questions and questions regarding their beliefs and attitudes about cellphone use and cervical cancer.
   2. Randomization:

   Participants will be randomized into either the intervention group or the control group using a randomization software that keeps the randomization sequence hidden. The control group will receive their usual care in each health center, which consists of different interventions depending on the health center they attend. Examples of usual care include periodic midwife visits, education by health personnel and cervical cancer health campaigns.

   c) Intervention: Women randomized to the intervention group will receive text and voice messages (designed with input from previous qualitative phase) sent to their cellphones that remind them to get a Pap smear, send them information about cervical cancer, and inform them of health clinic location and hours where they could get a Pap smear.
2. Qualitative phase:

The implementation of a mHealth intervention could fail for many reasons. Some of the previously described barriers for this and other types of mobile interventions are: restrictions in the number of characters in the text message, illiteracy, poor signal coverage and quality, and confidentiality and pertinence in families where cellphones are shared.

However, there may be many other factors that hinder or facilitate its effectiveness: lack of funds to keep credit on a cellphone throughout the entire month, losing the phone, little use of text messaging in the elderly, among others.

Investigators will carry out focus groups with women who receive care at the participating centers in order to define barriers and facilitators to a text message intervention that will promote Pap adherence.

Focus Groups Participants:

Women between 25 and 64 years old that meet the inclusion criteria for the study.

Midwives at the health care centers.

Investigators will carry out nine (9) focus groups in total. Women will let us know about barriers and facilitators to the use of this technology and midwives will help investigators to characterize the usual care that women receive and better inform text message content as well as barriers to their use.

Every community member that attends a focus group will receive an incentive of 5,000 Chilean pesos (8 USD) for their time and information. Each health professional that attends a focus group will receive 10,000 Chilean pesos (16 USD).

Data Encoding The focus groups will be led by individuals expert in qualitative methods and assisted by the Principal Investigator and a student assistant who will serve as a note-taker. The focus groups will be recorded for analysis.

The audio of the focus groups will be transcribed and coded using the software Atlas.ti version 6.2

Analysis Information will be analyzed using a qualitative content analysis process\* by two or more investigators who will extract relevant themes regarding usage patterns, barriers, and facilitators to this type of intervention. Investigators will use the conceptual framework called PRECEDE-PROCEED in order to carry out the analysis\*. Investigators will use it to identify predisposing factors that reinforce and enable the use of mobile technologies to improve Pap adherence.

The collected information will contribute to the design of the intervention, and from there the quantitative phase of the study will begin.

d) Sample size Previous studies have shown that without an intervention, around 30% of women who are not up-to-date with their Pap test will get a Pap within the following 6-12 months. Looking at literature regarding similar interventions for other pathologies, investigators anticipate seeing an absolute increase of 15% in adherence rate. With this difference in proportions, and alpha errors of 5% and beta errors of 20%, the estimated sample size is 176 per arm. Considering a loss of 10%, investigators will recruit an estimated 200 patients per arm.

e) Statistical Analysis Investigators will use descriptive statistics to characterize demographic variables of the included patients in the same manner as charactering the indicators of implementation.

For the primary outcome (proportion of women with an up-to-date Pap), investigators will use a chi-squared test to test differences in proportions.

For the multivariate analysis, investigators will use logistic regression and Poisson regression.

For the categorical variables, investigators will use a chi-squared test.

Messages For Your Health: A Cancer Screening Prevention Study

Development of Mobile Technologies for the Prevention of Cervical Cancer in Santiago, Chile: A Randomized Controlled Trial.

The information will be collected from the cancer registration and monitoring database (CITOEXPERT/REVICAN), where Pap data of the population at the national level is registered. Investigators will also review medical records from participating patients at the two health centers. The data collection will take place 6 months after initial recruitment.

Centro de Salud Familiar El Roble

Pontificia Universidad Catolica de Chile

Javiera Martínez MD, MPH

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Neoplasm Metastasis

Lymphoma

Caregiver Burden

Male Urogenital Diseases

Lymphosarcoma

Anti-Inflammatory Agents

All Drugs and Chemicals

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Caregivers of Latino/a advanced cancer patients

The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study:

1. A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish)
2. A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window.

Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention.

Weekly 45 minute Sessions

Kelly Trevino, PhD

This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this study, and a version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. We will use the culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants. This culturally sensitive intervention has the potential to reduce Latino/a patient and caregiver distress and improve patient and caregiver quality of life, shared understanding of the patient's illness, and patients' and caregivers' ability to discuss, identify, and document patients' treatment preferences. The intervention is designed to minimize burden to patients, caregivers, and healthcare institutions to allow for easy integration into clinical practice.

An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer

A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden

Weill Medical College of Cornell University

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Nervous System Diseases

Anxiety Disorders

Depressive Disorder

Breast Neoplasms

Parasomnias

Depression

Dyssomnias

Breast Diseases

Skin Diseases

Participants will attend 6 weekly educational and mindfulness sessions

Participants will be placed on a wait list

6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation

Mindfulness

Control group

Maria G Juarez-Reyes, MD, PhD

Lisa Golman-Rosas, PhD

The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression

Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention.

Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

The Acceptability scale was developed for this study and is a 5 point Likert scored scale that will be administered after end of each weeks for 6 weeks. There are two questions with scores ranging from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 8 with the higher scores representing greater levels of acceptability. It has 2 additional open ended questions: "What changes did you make in your daily routine as a result of this intervention, if none, why" and "Were there any barriers to making changes you listed on your action plan, if so what were they? The scale takes approximately 5 minutes to complete. Acceptability change will be measured after each session (week 1-6). The mean score with standard deviation for each 6 sessions and acceptability will be reported.

The Feasibility and Satisfaction scale was developed for this study and is a 5 point Likert scored scale that will be administered at at time of completion of intervention or at time of withdraw (if participant withdraws prior to completion of intervention.) Five questions are scored from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 20 with higher scores representing greater levels of feasibility. Differences in Feasibility will be evaluated and reported. There is also 1 open-ended question "What is the optimal number of visits" with continuous numeric score (participants able to write in number of preferred visits) with higher score representing desire for greater number of visits. The scale takes approximately 5-10 minutes to complete

The GAD7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3).Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Difference in GAD-7 measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be compared and reported. The scale takes approximately 5-10 minutes to complete

The CES-D scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3).Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.

The Participant Reported Outcomes Measurement Information System (PROMIS) Adult Short Form: Sleep Disturbance (PROMIS-SD), is an 8 item scale measuring overall sleep quality, disturbances, and satisfaction over the past 7 days on 5 point Likert scale with scores ranging from 1 to 5. Raw scores are converted into t scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance. Exploratory analysis will compare scores at three time points (week 1 and 6 of the intervention and 3 months post intervention). The scale takes approximately 2 minutes to complete 26 and is available in Spanish.

Stanford University

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

Total

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

Sex: Female, Male

Ethnicity (NIH/OMB)

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
Messages For Your Health: A Cancer Screening Prevention Study	NCT02376023	Cervical Cancer	mHealth	25 Years - 64 Years	Pontificia Universidad Catolica de Chile
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer	NCT03794635	Metastatic Canc... Locally Advance... Thoracic Cancer Gynecologic Can... Genitourinary C... Lymphoma	Weekly 45 minut...	18 Years -	Memorial Sloan Kettering Cancer Center
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer	NCT03794635	Metastatic Canc... Locally Advance... Thoracic Cancer Gynecologic Can... Genitourinary C... Lymphoma	Weekly 45 minut...	18 Years -	Memorial Sloan Kettering Cancer Center
Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients	NCT04834154	Breast Cancer Depression, Anx... Mindfulness Sleep Disturban...	Mindfulness Control group	18 Years -	Stanford University
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
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer	NCT03794635	Metastatic Canc... Locally Advance... Thoracic Cancer Gynecologic Can... Genitourinary C... Lymphoma	Weekly 45 minut...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for latina

Every month we try and update this database with for latina 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.

Spots Global Cancer Trial Database for latina

Every month we try and update this database with for latina 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 latina 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.