Participants having previously attended at least once in previous years the "World Cancer Day Walk" will be considered as the group exposed to the health education intervention (returning).

The control/non-exposed group will be the participants who are attending the "World Cancer Day Walk" for the first time in 2020 (first timers) and have not yet received health education information.

Healthy lifestyle information (education) is distributed to participants during the "World Cancer Day Walk" via brochure, lectures, and professional counseling.

Healthy Lifestyle Education

Leigh Leibel, MSc

Cancer awareness is a critical element of cancer prevention and control. Creating public awareness on risk factors, preventative strategies, and the importance of early screening is the foundation upon which a cancer control program must be constructed. The purpose of this study is to describe the sociodemographic and risk factor distribution of the Abuja, Nigeria "World Cancer Day Walk" participants according to their motive for participating in the event (free cancer screening versus fun/activities), and secondarily, to investigate the impact of the event on educating attendees from the general population about cancer prevention and screening, in particular the importance of being physically active and maintaining a healthy body weight. Obesity is a known risk factor contributing to the development of cancer and NCD's.

Cancer awareness is a critical element of cancer prevention and control. Creating public awareness on risk factors, preventative strategies, and the importance of early screening is the foundation upon which a cancer control program must be constructed. Ideally, efforts should include knowledge of the problem and its solutions, a group of people who respect and care for the populations they want to serve, and importantly, resources.

Nigeria is the most populous black nation in the world with a population of over 196 million, more than 500 ethnic groups, 380 languages, and a diverse range of cultural, traditional and religious beliefs. Nigeria constitutes approximately 20% of the population of Africa and slightly more than 50% of the West African population. Cancer is a critical public health problem in this population. Nigeria is a major contributor to the overall cancer burden on the continent with 72,000 cancer deaths in 2012 and 115,950 new cases of cancer and 70,327 cancer deaths in 2018. Nigerians also have one of the world's poorest 5-year cancer survival rates.

Breast cancer is the most frequently diagnosed cancer in Nigerian women and the leading cause of cancer death in Nigeria, with an estimated 26,310 new cases and 11,564 deaths in 2018 (44% death rate). Breast cancer incidence in this population historically has been low but is now increasing. By comparison, in the United States (population 329 million) there were 30,700 new breast cancer cases and 6,310 deaths in 2016. Another female cancer - cervical, is 99% preventable, however, it is the second leading cause of cancer death in Nigeria with over 26 deaths every day. By comparison, in the United States between 2013-2017, the average annual death rate of cervical cancer was 2.3% per 100,000 (age adjusted to the 2000 US standard population). Prostate cancer is the leading cause of cancer deaths in Nigerian men with 13,078 new cases (which is 29.1%) and 5,806 deaths in 2018. The age-standardized incidence rates (ASR) for prostate cancer was 32.8 new cases per 100,000 men and mortality rate was about 16.3 per 100,000 men in 2018. On a daily basis, at least 15 men die of prostate cancer in Nigeria. By comparison, in the United States prostate cancer death rates in men declined 52% from 1993 to 2017.

Strategies for prevention and early detection are imperative in the reduction of cancer death rates globally; awareness campaigns (such as the annual "World Cancer Day Walk" in Abuja) are critical to educate the general population on cancer risk factors, the benefits of screening and early detection, and to offer free cancer screening to all populations.

This study "Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians" will describe the sociodemographic and risk factor distribution of the Abuja, Nigeria "World Cancer Day Walk" participants according to their motive for participation, and secondarily, to investigate the impact of the event on educating attendees from the general population about cancer prevention and screening, in particular the importance of being physically active and maintaining a healthy body weight. Obesity is a known risk factor contributing to the development of cancer and NCD's.

The study will take place in Abuja, Nigeria on Feb 1, 2020 during the 6th Annual "World Cancer Day Walk" sponsored by Project PINK BLUE, a registered Nigerian nonprofit cancer organization, viz. Health \& Psychological Trust Centre (CAC/IT/NO 73960).

The purpose of the "World Cancer Day Walk" is to create awareness and advocate for better cancer care for Nigerians. The event offers free breast, cervical, and prostate cancer screenings; heath education and information about cancer risk reduction; and group physical activities that include a 5km Walk, 10km Race, 20km Ride, 5km Skate, 50km Cycle, and Marathon.

On the day of the event, the in-field research team will distribute a voluntary, one-page questionnaire to the anticipated 3,000 event participants to ascertain demographic information, cancer risk factors, motivations for attending the event, and lifestyle behaviors. Subjects will be recruited voluntarily onsite during the event following inclusion and exclusion criteria. Informed consent will be taken.

The questionnaire is 27 questions. Part one (eight questions) captures basic demographic information. Part two (six questions) captures personal and family history of cancer and cancer screening. Part three (six questions) captures information about the motivation for attending the event (free screening vs. fun/activities) and preferred ways to receive healthy lifestyle and cancer risk reduction / prevention information. Part four (five questions) captures lifestyle behaviors. Part five is the validated seven question International Physical Activity Questionnaire (IPAQ) instrument that measures physical activity and reduced sedentary behavior over the last seven days.

Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians

The brief survey instrument captures participant sociodemographic characteristics. Participants are asked to provide known risk factors for cancer and to indicate if they are attending for "free cancer screening" or "fun/activities".

The International Physical Activity Questionnaire (IPAQ) measures self-reported time spent per week doing vigorous and moderate activity in the last 7 days; time spent walking in the last 7 days, and time spent sitting down in the last 7 days. It is a "fill in the blank" survey instrument.

Project PINKBLUE, Health and Psychological Trust Centre

University Of Nigeria Teaching Hospital

Vaughn A. Lewis Institute for Research and Innovation

Columbia University

AshtaYoga, LLC

Symptoms and General Pathology

All Conditions

Fatigue

Herbal and Botanical

All Drugs and Chemicals

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

12 weeks of time-restricted eating (10-hour window)

Time-restricted eating

Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Healthy lifestyle education

Amber Kleckner, PhD

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism.

The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial

To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.

FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long, and a higher score indicates less fatigue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians	NCT04248881	Cancer Preventi...	Healthy Lifesty...	18 Years -	AshtaYoga, LLC
Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians	NCT04248881	Cancer Preventi...	Healthy Lifesty...	18 Years -	AshtaYoga, LLC
Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians	NCT04248881	Cancer Preventi...	Healthy Lifesty...	18 Years -	AshtaYoga, LLC
Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians	NCT04248881	Cancer Preventi...	Healthy Lifesty...	18 Years -	AshtaYoga, LLC
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue	NCT05256888	Neoplasms Therapy Fatigue Diet Therapy Time Survivorship Fasting, Interm...	Time-restricted... Healthy lifesty...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for healthy lifestyle education