Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Body Weight

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Session 1:The Breakfast Club: ways to increase the healthiness of breakfast and all meals.

Session 2: Calcium and Vitamin D -Keys to Bone Health

Session 3: Fruits and Veggies -Your New Best Friends

Session 4: Let's Talk About Fat

Session 5: Shopping Therapy

Session 6: Celebrity Chefs Share Their Secrets

Dietary intervention

Carolyn Gotay, PhD

Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new cases estimated for 2015. Prostate cancer patients often live with uncomfortable side effects of treatment, such as a decrease in bone health, weight gain, and challenges to their interpersonal relationships. Nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for prostate cancer survivors and their partners.

The objectives are to assess the feasibility of the intervention, specifically:

* Accrual, retention and adherence, and participant satisfaction
* Candidate measures for primary outcomes in future studies

The intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.

Prostate cancer (PCa) is the most commonly-diagnosed invasive cancer in Canada, with 24,000 new cases predicted for 2015. The large majority of men (96%) will survive five or more years post-diagnosis. However, many PCa survivors live with side effects of the disease and treatment and may develop chronic conditions due to aging and/or cancer therapy. The PCa-related side effects can also impact men's interpersonal relationships. Effective interventions to promote health and well-being for PCa survivors are urgently needed.

Evidence shows that nutrition can improve outcomes for PCa survivors; however, dietary interventions for prostate cancer patients are limited. Furthermore, all PCa-related interventions reported thus far are limited in one important way: they focus only on the patient/survivor. Yet, the impact of prostate cancer extends to the spouse as well. When it comes to lifestyle interventions, responsibility for health behaviours and food preparation typically falls on the wife, particularly in today's cohort of PCa patients. As such, engaging the partner is crucial to ensure success for the survivor, and provide benefits for the wife as well.

Therefore, this is a feasibility study that tests the impact of an innovative intervention to promote healthy nutrition and weight control for PCa survivors and their partners.

The objectives are to assess the feasibility of the intervention, specifically:

* Accrual, retention and adherence, and participant satisfaction
* Candidate measures for primary outcomes in future studies

The study draws on Interdependence Theory and features of successful cooking class intervention research in other populations. Specifically, it uses hands-on cooking experience, combined with increased cooking skills and nutrition knowledge to build skills and self-efficacy; to be culturally appropriate and use simple affordable ingredients; and to involve the spouses.

The dietary intervention will be offered to a total of 24 couples (48 individuals). The intervention includes 6 cooking and nutrition-related classes, that are held weekly in a university classroom kitchen with interactive demo and cooking components. Classes focus on learning through preparing theme-based recipes, with themes organized around prostate health.

Feasibility outcomes are assessed throughout. Questionnaire-based outcomes are assessed pre- and post-intervention, anthropometric outcomes at first and last intervention session.

The main intent is to evaluate how well the classes work and identify ways to make them more successful. At the end of the study, the investigators will know if this approach shows merit to be tested further through a randomized controlled trial.

Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners

Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Pilot Study

Canadian Cancer Society (CCS)

University of British Columbia

Professor

Nutritional and Metabolic Diseases

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Weight Loss

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Body Weight Changes

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

PADI

Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Patrick Maisonneuve

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

long-term weight control or maintenance via calibrated scales, stadiometer

change in total step count via pedometer device with electronic data transmission

change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

change in dietary intake via Food Frequency Questionnaire

change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

change in oestradiol assessed by blood samples

change in insulin assessed by blood samples

change in glucose assessed by blood samples

change in C-reactive protein assessed by blood samples

Associazione Italiana per la Ricerca sul Cancro

European Institute of Oncology

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Ovarian Neoplasms

Lymphoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Endometrial Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Endocrine System Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Ovarian Cancer

Lymphosarcoma

Renal Cell Carcinoma

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.

Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health

Diet-Exercise

Exercise-Diet

Combined Diet and Exercise

Wendy Demark-Wahnefried, PhD, RD

This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm will be evaluated at baseline, 6-, 12-, and 18-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin.

It is hypothesized that cancer survivors assigned to all three of these study arms will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.

Participants will participate in one of three arms:

1. Diet followed by Exercise intervention
2. Exercise followed by Diet intervention
3. Combined Diet and Exercise intervention

Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not.

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health

We agree to share any remaining biospecimens, including plasma, sera, and buffy coat (some stored in RNAlater® and some stored alone). Samples will be accompanied by a limited dataset of deidentified participant data that investigators need for analyses. To facilitate the data sharing, we plan to build a central archive that will allow public access to data dictionaries and limited-access anonymized datasets. We will develop a single password protected Share Point web system so that all data dictionaries, documentation, and data accessibility will have a consistent user interface. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). Data will be made available as either a SAS export dataset, or as a tab-delimited ASCII file.

Participants will complete the 14-item Perceived Stress Scale

Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha

The 43-item Older Americans Resources \& Services (OARS) Questionnaire will be administered

Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006

Questions include: smoking status, falls, serious health events

Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

Participants will complete two dietary recalls (one weekday and one weekend day)

Participant body weight will be measured during an in-person or remote (Zoom) visit

Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.

Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.

Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.

Waist circumference will be measured using an unmarked tape at the level of the umbilicus during in-person or remote assessments.

Waist circumference will be measured using an marked tape at the level of the umbilicus during the in-person or remote assessments.

To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine \[creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element\], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day

Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.

Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners	NCT02954289	Prostate Cancer	Dietary interve...	18 Years -	University of British Columbia
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health	NCT04000880	Breast Cancer Colorectal Canc... Endometrial Can... Kidney Cancer Multiple Myelom... Ovary Cancer Prostate Cancer Thyroid Cancer Non-Hodgkin Lym...	Adapting MultiP... Diet-Exercise Exercise-Diet Combined Diet a...	50 Years -	University of Alabama at Birmingham
Cooking Class Intervention Project for Men With Prostate Cancer and Their Partners	NCT02954289	Prostate Cancer	Dietary interve...	18 Years -	University of British Columbia
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health	NCT04000880	Breast Cancer Colorectal Canc... Endometrial Can... Kidney Cancer Multiple Myelom... Ovary Cancer Prostate Cancer Thyroid Cancer Non-Hodgkin Lym...	Adapting MultiP... Diet-Exercise Exercise-Diet Combined Diet a...	50 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for weight control