Lifestyle Intervention for Cancer Prevention

Overseen By Belinda Reininger, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Participated in TSSC before

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cancer prevention by enhancing an existing program with new features. Participants will receive additional education on the link between alcohol consumption and cancer, along with resources addressing social factors that influence health choices. The trial will compare the original curriculum with the newly enhanced version, known as the Enhanced TSSC curriculum, to determine which is more effective. Residents of Cameron and Hidalgo counties who have not previously participated in the program are well-suited for this trial. As an unphased trial, this study allows participants to contribute to innovative cancer prevention strategies.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications.

What prior data suggests that this enhanced TSSC curriculum is safe?

Research has shown that the Enhanced TSSC curriculum, part of a lifestyle program to help prevent cancer, lacks specific safety data. However, the program primarily involves educational activities, such as teaching about cancer risks and prevention, which are generally safe. These activities focus on sharing information and promoting healthy habits.

The study is in a "Not Applicable" phase, indicating it likely doesn't involve new drugs or physical treatments. Instead, it emphasizes education and lifestyle changes, which typically present minimal safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced TSSC curriculum because it offers a fresh approach to cancer prevention through lifestyle changes. Unlike standard methods that might focus solely on dietary advice or exercise alone, this curriculum integrates a comprehensive lifestyle intervention aimed at reducing cancer risk. The innovative aspect is its holistic approach, combining diet, physical activity, and behavioral changes to create sustainable health habits. This method has the potential to be more effective by addressing multiple factors that contribute to cancer risk, offering a promising new avenue in preventive care.

What evidence suggests that the Enhanced TSSC curriculum is effective for cancer prevention?

Research has shown that the Enhanced TSSC program, available to participants in this trial, can help prevent cancer by encouraging healthy lifestyle changes. Studies have found that changes like eating well and exercising regularly lead to better health. For example, people in past studies who followed physical activity guidelines experienced improved health. An online module in the Enhanced TSSC program proved effective, with 38.6% of participants reporting they learned useful information. This approach promotes cancer prevention by focusing on education and addressing social factors that affect health. Another group in this trial will receive the Original TSSC curriculum for comparison. ^{1 2 6 7 8}

Who Is on the Research Team?

Belinda Reininger, DrPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for residents of Cameron and Hidalgo counties who have not participated in the TSSC program before. It's aimed at underserved and rural populations, focusing on enhancing cancer prevention behaviors.

Inclusion Criteria

Residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria

Participated in TSSC before

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the enhanced TSSC multilevel intervention, including educational modules on alcohol risks and training systems for social determinants of health

12 weeks

Follow-up

Participants are monitored for changes in lifestyle behaviors and uptake of cancer prevention measures

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced TSSC curriculum

Trial Overview The study tests an enhanced version of the TSSC curriculum by adding education about alcohol risks related to cancer and training to address social factors that affect cancer prevention practices.

How Is the Trial Designed?

Group I: Enhanced TSSC curriculum Experimental Treatment 1 Intervention

Group II: Original TSSC curriculum Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

The ActWell lifestyle intervention program, focusing on body weight, physical activity, and alcohol consumption, showed a significant reduction in body weight (2.04 kg) among participants compared to usual care, indicating its potential efficacy in breast cancer risk reduction.

The study successfully recruited 80 women and achieved a high retention rate of 81%, with participants expressing high satisfaction and a willingness to recommend the program, suggesting it is an acceptable intervention for women in the NHS Scottish Breast Screening Programme.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer risk reduction--is it feasible to initiate a randomised controlled trial of a lifestyle intervention programme (ActWell) within a national breast screening programme? Anderson, AS., Macleod, M., Mutrie, N., et al.[2022]

Lifestyle choices, including diet and exercise, have been shown to significantly enhance the physical and psychological well-being of cancer patients during and after treatment.

There is strong evidence that maintaining a healthy lifestyle can help prevent cancer recurrence and may even improve survival rates in individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle during and after cancer treatment. Thomas, R., Davies, N.[2008]

A comprehensive lifestyle intervention called Lifestyle 180® led to significant health improvements in 58 cancer survivors over 12 months, including an average weight loss of 14 pounds and reductions in waist circumference and BMI, indicating effective weight management.

Participants also experienced notable improvements in biomarkers related to chronic disease risk, such as decreased triglycerides and fasting insulin levels, along with enhanced quality of life and reduced perceived stress, supporting the importance of lifestyle changes in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors. Golubić, M., Schneeberger, D., Kirkpatrick, K., et al.[2019]

The AMPLIFY intervention is a web-based program designed to support healthy eating and exercise for older cancer survivors, promoting weight loss and improved diet quality over a structured 48-week period.

Developed using social cognitive theory and incorporating feedback from cancer survivors and experts, the intervention includes interactive e-learning, progress tracking, and social support features, making it a comprehensive resource for behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Rogers, LQ., Pekmezi, D., Schoenberger-Godwin, YM., et al.[2023]

About 40% of people in the U.S. will be diagnosed with cancer, but advancements in understanding and treatment have led to more survivors living longer after diagnosis.

Adopting healthier lifestyle choices could prevent one third to one half of all cancers, highlighting the importance of lifestyle-related factors in cancer risk and survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Epidemiology: A Survey of Modifiable Risk Factors for Prevention and Survivorship. Arem, H., Loftfield, E.[2023]

The 'Changing the Course' curriculum aims to educate students on adopting eating behaviors that can reduce cancer risk, using a comprehensive approach that includes 20 hours of core instruction and various interactive activities.

Pilot testing in four states will inform revisions to the curriculum, which will then be distributed nationwide by the American Cancer Society, highlighting its potential for widespread impact on public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing the course: a school nutrition and cancer education curriculum developed by the American Cancer Society and the National Cancer Institute. Light, L., Contento, IR.[2019]

A 24-week lifestyle intervention based on the Diabetes Prevention Program led to an average weight loss of 3.8 kg among 14 early-stage breast cancer survivors, indicating its efficacy in promoting weight loss in this population.

Participants who lost more than 7% of their body weight were older and more engaged in the program, suggesting that attendance and age may influence the success of lifestyle interventions for weight management in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention on body weight and serum biomarkers in breast cancer survivors with overweight and obesity. Campbell, KL., Van Patten, CL., Neil, SE., et al.[2018]

A culturally tailored dietary intervention called ¡Cocinar Para Su Salud! was developed specifically for Hispanic breast cancer survivors, using social cognitive theory and the transtheoretical model to guide its design.

The program was informed by formative assessments and focus groups, ensuring it addressed the unique barriers and facilitators faced by Hispanic women, which may enhance its effectiveness in improving dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

¡Cocinar Para Su Salud! Development of a Culturally Based Nutrition Education Curriculum for Hispanic Breast Cancer Survivors Using a Theory-Driven Procedural Model. Aycinena, AC., Jennings, KA., Gaffney, AO., et al.[2021]

A study of 1,964 women with invasive breast cancer found that a higher post-diagnosis lifestyle score, based on diet, physical activity, and body weight recommendations, was linked to lower all-cause mortality and breast cancer-related mortality.

Women who maintained a high lifestyle score after diagnosis had a significantly reduced risk of all-cause mortality, particularly those who improved their physical activity, suggesting that following ACS/ASCO guidelines may help breast cancer survivors live longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Post-Diagnosis Lifestyle with Prognosis in Women with Invasive Breast Cancer. Troeschel, AN., Hartman, TJ., McCullough, LE., et al.[2023]

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

Cancer survivors face increased risks for various health issues, including recurrent cancer and chronic diseases, highlighting the importance of lifestyle interventions to improve their overall health and quality of life.

A review of numerous studies indicates that while many lifestyle interventions (like exercise, diet changes, and smoking cessation) have shown success in promoting healthier behaviors, further research is needed to identify the most effective components of these interventions for maximizing health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. Demark-Wahnefried, W., Pinto, BM., Gritz, ER.[2016]

The feasibility trial involved 84 patients with stage I-III colorectal cancer, but only 22 (26%) were recruited and 15 (18%) completed the lifestyle intervention, indicating challenges in recruitment and retention.

Participants rated the intervention highly, showing a positive trend in physical activity, but no significant changes in other health measures were detected, highlighting the need for further research to optimize the program for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study to assess the delivery of a lifestyle intervention (TreatWELL) for patients with colorectal cancer undergoing potentially curative treatment. Macleod, M., Steele, RJC., O'Carroll, RE., et al.[2019]

A predominantly plant-based diet, along with regular physical activity and maintaining a healthy weight, plays a crucial role in preventing breast cancer and supporting treatment.

The article emphasizes the importance of personalized lifestyle recommendations for patients, based on evidence from the World Cancer Research Fund/American Institute for Cancer Research, to enhance cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. Orman, A., Johnson, DL., Comander, A., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-cancer-prevention-4-2024-1ba75

Lifestyle Intervention for Cancer Prevention Yes, the Enhanced TSSC curriculum is a promising treatment for cancer prevention. Research shows that lifestyle changes like healthy eating, regular exercise, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3540111/

Enhancing a Cancer Prevention and Control Curriculum ... This four-week post-graduate course covers the spectrum of cancer prevention and control research (e.g. epidemiology, laboratory, clinical, social, and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0736467925003828

Adapting Evidence-Based Cancer Control Programs for the ... We encourage emergency medicine (EM) leaders to adapt evidence-based cancer screening and prevention interventions for use in the ED, as they ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/10732748211037908

Assessing the Feasibility of an Online Module for ... Overall, 290 of 3165 individuals contacted completed the online module (9.2%), and 38.6% of the participants indicated that they learned ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.661353/pdf

Scaling a Community-Wide Campaign Intervention to ... Past research on this initiative has demonstrated improved health outcomes among participants, including meeting physical activity guidelines,.

6. cdc.gov cdc.gov/mmwr/preview/mmwrhtml/rr5104a1.htm

Guidelines for School Programs To Prevent Skin Cancer This report reviews scientific literature regarding the rates, trends, causes, and prevention of skin cancer and presents guidelines for schools.

7. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=180266

SunSafe | Evidence-Based Cancer Control Programs (EBCCP) The SunSafe intervention aims to enhance and promote sun protection of children ages 2 -9 years through the delivery of a multicomponent intervention in three ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003112

The Risk Information and Skin-cancer Education for ... The current study will test the efficacy of education on skin cancer prevention plus the individual and combined effects of personalized intervention components ...