Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Skin Diseases

Individuals randomized to intervention group 1 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 AND will receive additional skin cancer screening educational materials.

Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.

Individuals randomized to the intervention group will receive skin cancer screening educational materials.

Intervention Arm

All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.

AAD SPOTmeⓇ skin cancer screening

Alan Geller, MPH, RN

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Evaluation Study of SPOTme® Skin Cancer Screenings

Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the period following patient's receipt of an AAD SPOTme® skin cancer screening to the baseline assessment.

Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the 3 months prior to the 6-month follow up assessment

Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 3 months prior to the 6-month follow up assessment

Self-report of patient attitude towards use of sun protection will be defined by likelihood of engaging in sun protection practices in the year following the 6-month follow up assessment

American Academy of Dermatology (AAD)

Harvard School of Public Health (HSPH)

MPH, RN

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA .

The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.

Medhi JEAN-LAURENT, MD

In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type 2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although targeted therapies are used in many types of cancer, they are still possible a minority of patients. In current practice, endometrial cancers do not benefit these therapies. Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial carcinoma could help to identify biomarkers predictive of a response to targeted therapies. We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.

Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of metastatic recurrence and death even when diagnosed at early stages. They also have few therapeutic options. The Characterize the mutations responsible of cancer development has led to develope "precision medicine" that targets "actionable genes" by a drug. This concept of actionable mutation refers to a change in the DNA molecule that can predict the response to a drug defined as targeted therapy. Although targeted therapies are used in many types of cancer, they still target a minority of patients. Some tumor sites still do not benefit from these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few therapeutic options. The characterization of molecular mechanisms, by Next Generation Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2 cancers, should allow the identification of predictive biomarkers for response to certain targeted therapies.

Samples for extraction of DNA on whole blood

Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

Characterization of potentially operable mutations in type 2 endometrial tumors from DNA sample withdraw at inclusion and during follow visit

Martinique Cancer Registry

University Hospital Center of Martinique

Breast Neoplasms

Breast Diseases

Participants randomized to the Intervention Arm will be provided with the website link to the online psychosocial program and the questionnaire and distress survey. They will be asked to use the website within two weeks and then to complete the questionnaire and distress survey after using it and mail them back in a self-addressed stamped envelope. The participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted.

Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.

Participants randomized to the Intervention Arm will be provided with the website link to the online self-help program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then to complete these documents after using it and mail them back in a self-addressed stamped envelope. Same documents will be administered at the 3-month follow-up period, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. Additionally, participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted. The focus groups will last about 1-1.5 hours and consist of 3-4 participants. Focus groups will be audio-taped and conducted in either English or Chinese.

Control Group

Terry Cheng, PhD

Terry Cheng

The purpose of the study is to evaluate the effectiveness of an online psychosocial self-help program for Chinese immigrant women with breast cancer, by comparing Chinese immigrant women who receive the online psychosocial program and those who do not receive the program.

The investigators want to understand if this online psychosocial program is effective in helping Chinese immigrant women to feel more supported, understand that the distress is normal, engage in self-care activities, become aware of the community resources, feel more confident about returning to a normal life, and feel less distress overall as they return to life after treatment. This information will help us to better understand these Chinese immigrant women's needs and concerns and plan future growth of the program to meet their personal, cultural, and language needs.

This study will be conducted over a three-year period at the Princess Margaret Cancer Centre (PM), University Health Network. The mixed-methods study design will include a longitudinal survey and a focus group component. Quantitative assessments will be conducted at three time periods: pre-intervention (T0), within 2 weeks post-intervention (T1), and three months post-intervention (T2). Two small focus groups will be conducted to deepen the understanding of the participants', who received the online psychosocial program, experience of the intervention.

The online psychosocial self-help program (www.asianbrcarecovery.ca) website is hosted with University Health Network Digital, build on the SharePoint 2013 Platform. The website is an anonymous website with open access to the general public, including Control Group participants. They may come across the online psychosocial program if they search the internet for information. A question was included in the Control Group 3-month follow-up questionnaire to track if the participants found and used the website.

Recruitment. Recruitment will be conducted by a research assistant (RA) who is fluent in English and Chinese either in-person or by telephone. The oncologist will approach each patient coming to the hospital for treatment or from virtual visits using hospital approved Ontario Telemedicine Network and introduce the study. If the participant is interested to hear more about the study, the oncologist will ask for the participant's consent to release her contact information to the RA. The RA will contact the participant and explain the nature and demands of the study, go through the informed consent form with her, and answer any questions. If the participant agrees to participate, written informed consent, Participant Demographics questionnaire, and baseline distress survey (T0) will be mailed to the participant with a return self-addressed stamped envelope prior to randomization. The two community partners (South Riverdale Community Health Center and Senior Persons Living Connected) will also help with identifying participants. The group leaders at the monthly Chinese cancer psychoeducational groups will introduce the study and if the participant is interested, they will ask for the participant's consent to have her contact information provided to the RA. The recruitment process will remain the same. The participant will be asked to complete these documents in two weeks.

Participants will be randomly assigned in a 1:1 ratio to the online psychosocial intervention (INT) or the standard care control group (CTL) by using a list of randomly generated numbers (www. Random.org): when a participant is enrolled, she will be assigned the next consecutive number in the list. Participants receiving an odd number will be assigned to the CTL condition, and those receiving an even number will be assigned to the INT condition.

Intervention Arm. Following the receipt of completed baseline (T0) questionnaires, the participants randomized to the INT group will be provided with the website link to the online psychosocial program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then complete the questionnaire and distress survey after using it (T1) and mail them back in a self-addressed stamped envelope. The RA will call participants with a reminder if completed questionnaires have not been received by the third week. The questionnaire and survey will be administered at the 3-month follow-up period (T2) either at a participant's clinic visit or by mail, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. A reminder call will be made after the two-week period. The questionnaires will take about 10 minutes to complete.

INT participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. For those who have expressed an interest will be contacted. The focus groups will last about 1-1.5 hours and consist of 3-4 participants; the small group size will afford more focused solicitation of the primary outcomes. Focus groups will be audio-taped and conducted in either English or Chinese.

Control Group. Participants randomized to the CTL group will receive standard care. At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), the RA will mail the questionnaire and distress survey for completion. Participants will be given two weeks to complete the questionnaire and distress survey. A self-addressed stamped envelope will be provided to mail them back. A reminder call will be made after the two-week period. The questionnaire and distress survey will be administered at the 3-month follow-up period (T2) either at the participant's clinic visit or by mail. The questionnaires will take about 10 minutes to complete. Once the 3-month follow-up package is received, each participant will be provided with the website link to view the self-help program.

Data Collection. Quantitative data will be collected with a pre/post measure of emotional distress (anxiety and depression), questionnaires, and website analytics (e.g., number of visits to the website per individual). All measures used in the study will be available in both English and Chinese (traditional and simplified versions), and participants will be asked about their language preference. Qualitative data will be collected from two small focus groups.

Measures. Socio-demographic and medical information will be collected with a self-report information form (Patient Demographics questionnaire) created by the research team. Any study materials that are in English (i.e., consent forms, socio-demographic information form, and questionnaires) will be professionally translated to Chinese (simplified and traditional), to accommodate the diversity in the Chinese population. The translated documents will be reviewed by the Chinese members of the team and recommendations made until acceptable Chinese-translated versions are agreed upon.

Statistical Analysis. Data will be analyzed using SPSS version 25. Participant characteristics and baseline outcome measures will be summarized using descriptive statistics. The equivalence of groups at baseline on basic demographic and medical variables will be assessed using independent t-tests and chi-square tests, and variables demonstrating any significant group differences (p\<.05) will be included as covariates in the primary analyses. A data dictionary will be created containing detailed descriptions of each variable and coding information. Data checks will be verified by the study investigator.

To evaluate the effect of the online self-help program, the main and interaction effects of treatment group (INT and CTL) and time (T0, T1, and T2) on each of the primary outcomes will be examined using separate mixed ANCOVA models, controlling for any empirically identified covariates. Hedges' g and associated confidence intervals will be calculated to estimate effect sizes both over time (within groups) and between groups. Alpha will be set at 0.05, and probability values will be two-tailed. Missing data will be evaluated on a case-by-case basis such that drop-outs will be excluded.

Qualitative Data Analysis. Focus group interviews will be transcribed verbatim. Content analysis will be used to analyze focus group transcripts and identify categories and themes. Constant comparison will be undertaken by staying close to the data, identifying negative cases, and comparing themes and patterns. NVivo 10 will be used for data management.

A small honorarium will be provided to each participant at every single time period they complete the measures to compensate for the time taken to participate. Similarly, a small honorarium will be provided to the participants attending the focus groups to compensate them for their time and transportation expenses.

An Impact Assessment of a Culturally Tailored Online Psychosocial Program for Chinese Immigrant Women With Breast Cancer

An Impact Assessment of a Culturally Tailored Online Psychosocial Self-Help Program for Chinese Immigrant Women With Breast Cancer

A 17-item questionnaire was developed to evaluate the four primary outcomes. Each outcome variable is assessed with 4 questions that include 7-point rating scales (strongly disagree, disagree, somewhat disagree, neutral, somewhat agree, agree, and strongly agree). One multiple-choice question was included asking about the types of social/recreational activities the participant is engaged in. This questionnaire will be administered to both the Intervention Arm and Control Group. For the Intervention Arm, an additional 4 questions were included in the questionnaire at the two-week and 3-month follow-up periods asking about the impact of the online psychosocial program: the importance and usefulness of information in the website, the frequency of website visits, and the participant's interest in participating in a focus group. For the Control Group, one extra question was included in the 3-month follow-up questionnaire asking the participants if they found the website and used it.

Hospital Anxiety and Depression Scale (HADS) is a 4-item scale used to assess levels of anxiety and depression in cancer populations. It is a well validated and frequently used self-reported measure consisting of a 4-point Likert rating scale ranging from 0 (not a problem) to 3 (high level of problems).

University Health Network, Toronto

Control arm

Dietetic follow up + adapted physical activity

Intervention arm

Patrick BACHMANN, MD

Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

With approximately 52,600 new cases diagnosed in France in 2010, breast cancer is the most common cancer in women, according to national projections of the incidence and cancer mortality for 2010.

Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity).

Several hypotheses explain the association between obesity and breast cancer: obesity, metabolic syndrome and diabetes participate to changes in hormone levels (estrogen, leptin, insulin) that promotes mammary carcinogenesis and tumor progression.

The association between obesity and development of breast cancer is partly due to increased serum levels of estradiol produced by adipocytes, but the role of insulin resistance and inflammation associated with obesity is widely discussed.

Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Thus, several large cohort studies of women with breast cancer showed an average mortality reduction of 45% associated with moderate physical activity compared with inactivity. Adapted Physical Activity (APA) could also improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

A rich fruits and vegetables diet combined with regular physical activity appears to offer the best protection from breast cancer. The nature, frequency, duration, intensity and arrangement of physical training program meetings are key elements to consider, metabolic responses differ according to these factors.

The optimal management for an improved level of physical activity appear to be an individual of at least three sessions per week, 30 to 60 minutes each with a moderate intensity, allowing a physiological response to chronic exercise and an adequate recovery.

After diagnosis of breast cancer, there is thus many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Proportion of patients who participate in at least two mandatory APA sessions by week during all the APA program, except during the 1st week of each course of CT

Rate of patients who completed the full program and analysis of non-compliance grounds during the program

Number of patients contacted by the investigator to participate in the study and rate of patients randomized

Formalization of a program used in real conditions

Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction

Settlement expenses costs, incurred costs and costs avoided by the intervention

Analyses of metabolomic profiles and adipokines expression linked to breast cancer at initial diagnosis (before surgery) and description of metabolism changes during nutritional interventions and therapeutic care

Collection of patient nutritional intake during 3 days by self-administered questionnaire

Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)

Measurement of weight, height, waist and hip circumference

Measurement of total cholesterol, HDL, LDL and triglycerides

Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)

score calculation of anxiety (STAI questionnaire)

score calculation of QSCPGS questionnaire

Measurement of body composition by impedancemetry

score calculation of self-perception (QSCPGS questionnaire)

score calculation of self-esteem (Rosenzweig scale)

score calculation of depression (BDI questionnaire)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation Study of SPOTme® Skin Cancer Screenings	NCT03564769	Skin Cancer	Intervention Ar... AAD SPOTmeⓇ ski...	18 Years -	Harvard School of Public Health (HSPH)
Evaluation Study of SPOTme® Skin Cancer Screenings	NCT03564769	Skin Cancer	Intervention Ar... AAD SPOTmeⓇ ski...	18 Years -	Harvard School of Public Health (HSPH)
Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique	NCT03766672	Endometrial Neo...	Intervention Ar...	-	University Hospital Center of Martinique
An Impact Assessment of a Culturally Tailored Online Psychosocial Program for Chinese Immigrant Women With Breast Cancer	NCT04656353	Breast Cancer	Intervention Ar... Control Group	18 Years -	University Health Network, Toronto
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy	NCT01331772	Breast Cancer Adequate Physic...	Control arm Intervention ar...	18 Years - 75 Years	Centre Leon Berard
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy	NCT01331772	Breast Cancer Adequate Physic...	Control arm Intervention ar...	18 Years - 75 Years	Centre Leon Berard

Spots Global Cancer Trial Database for intervention arm