Health Promotion Tools for Colorectal Cancer Survivors

(TTBF Trial)

Recruiting at 1 trial location

Overseen By Evelyn Montenegro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Severe cardiovascular, Respiratory, Musculoskeletal, Psychiatric, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different tools can help cancer survivors improve body weight, nutrition, and physical activity. Individuals who have completed treatment for cancers such as breast, colon, or prostate may find this trial relevant. Participants will receive personalized reports and various support tools, including text messages, health kits, or coaching, for 48 weeks. A smartphone is necessary for participation, and a support person is required. The study includes the "Tools To Be Fit" program, a nutrition and physical activity intervention for cancer survivors. As an unphased trial, it offers a unique opportunity for cancer survivors to enhance their health and well-being with innovative support tools.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, hormonal treatments for breast and prostate cancer are allowed, and co-enrollment in some trials involving medication is permitted.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the tools in this program, such as personalized reports, text messages, and digital health kits, are safe for participants. Specifically, high-intensity exercise, a program component, has proven safe and effective for colorectal cancer survivors. This ensures that the suggested exercises and activities are both manageable and generally safe. These tools aim to enhance diet and physical activity, which are linked to better health outcomes for cancer survivors.

Additionally, the American Cancer Society’s guidelines, supported by these tools, are based on well-researched advice promoting good nutrition and regular exercise. These guidelines are widely recognized as safe and beneficial for cancer survivors. Participants in this program can expect the activities and advice to be easy to follow and aligned with trusted health practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these health promotion tools for colorectal cancer survivors because they offer a comprehensive approach to improving lifestyle habits. Unlike standard care, which often focuses on medical and surgical treatments, this program integrates personalized nutrition and physical activity guidance aligned with ACS guidelines. It also leverages technology through digital toolkits, text messages, and health coaching sessions, aiming to support long-term behavior change and improve quality of life. This multi-faceted support system, including coaching for both patients and their support persons, sets it apart by encouraging sustainable lifestyle improvements tailored to cancer survivors.

What evidence suggests that this trial's intervention components could be effective for colorectal cancer survivors?

Research has shown that following the American Cancer Society's Nutrition and Physical Activity Guidelines can help colorectal cancer survivors live longer. This trial will evaluate various health promotion tools for these survivors, including text messages, digital health tool kits, and health coaching. Studies have found that programs focused on improving exercise and diet can enhance quality of life and increase activity levels. Evidence suggests these programs lead to significant improvements in healthy habits. Additionally, participants have reported positive experiences and outcomes from these programs. Overall, adhering to these guidelines is linked to better health for cancer survivors. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin Van Blarigan, ScD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for colorectal cancer survivors, aged 18 or older, who have completed treatment and are ready to improve their nutrition and physical activity. They must own a smartphone, speak English or Spanish, and have a supportive person willing to help. Exclusions include those with exercise contraindications without physician clearance, recent app-based diet/activity tracking, planned major surgeries during the study period, other active cancers (with exceptions), current participation in similar trials, pregnancy intentions during the study period.

Inclusion Criteria

I have finished all my initial cancer treatments except for hormone therapy.

I have been diagnosed with a specific type of cancer (bladder, breast, colon, endometrial, kidney, ovarian, prostate, or rectal).

It has been over 4 weeks since my last major surgery.

Exclusion Criteria

ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity

I do not have any major surgeries planned during the study, except for minor procedures.

Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive various combinations of text messaging, digital health tool kit, health coaching, and support person training to improve nutrition and physical activity

48 weeks

15 health coaching sessions, 4 support coaching sessions

Follow-up

Participants are monitored for changes in ACS guideline scores, nutrition, physical activity, and other health markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tools To Be Fit

Trial Overview The trial tests four 'tools' designed to help colon or rectal cancer survivors manage their body weight through better nutrition and physical activity. These tools align with American Cancer Society guidelines and include questionnaires, counseling sessions via text messages and digital health toolkits aimed at promoting healthier lifestyle choices after cancer treatment.

How Is the Trial Designed?

Group I: Condition XVI (study booklet) Experimental Treatment 2 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer.

Group II: Condition XV (support coach) Experimental Treatment 3 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group III: Condition XIV (health coach) Experimental Treatment 3 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.

Group IV: Condition XIII (health coach, support coach) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group V: Condition XII (health kit) Experimental Treatment 3 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks.

Group VI: Condition XI (health kit, support coach) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group VII: Condition X (health kit, health coach) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.

Group VIII: Condition VIII (text) Experimental Treatment 3 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks.

Group IX: Condition VII (text, support coach) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group X: Condition VI (text, health coach) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.

Group XI: Condition V (text, health coach, support coach) Experimental Treatment 5 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group XII: Condition IX (health kit, health coach, support coach) Experimental Treatment 5 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group XIII: Condition IV (text, health kit) Experimental Treatment 4 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.

Group XIV: Condition III (text, health kit, support coach) Experimental Treatment 5 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Group XV: Condition II (text, health kit, health coach) Experimental Treatment 5 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.

Group XVI: Condition I (text, health kit, health coach, support coach) Experimental Treatment 6 Interventions

Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

Tools To Be Fit is already approved in United States for the following indications:

Approved in United States as Tools To Be Fit for:

• Improving nutrition and physical activity habits in cancer survivors

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Robert H. Lurie Cancer Center

Collaborator

Trials

23

Recruited

1,800+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-week pilot study involving 42 colorectal cancer survivors showed that using a Fitbit and receiving daily text messages was feasible and well-received, with 88% of participants feeling motivated to exercise.

However, the intervention did not result in a statistically significant increase in moderate-to-vigorous physical activity compared to the control group, indicating that further research is needed to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-monitoring and reminder text messages to increase physical activity in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial. Van Blarigan, EL., Chan, H., Van Loon, K., et al.[2020]

Only 25.60% of colorectal cancer survivors in the study met the physical activity guidelines, indicating a need for improved activity levels among these patients.

Factors such as fatigue, body image, depression, and self-efficacy were found to be closely linked to physical activity levels, suggesting that addressing these issues could help increase physical activity in colorectal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. Kang, DQ., Li, Y., Chen, ZQ., et al.[2021]

A survey of 495 colorectal cancer survivors revealed that common barriers to physical activity included fatigue from cancer and its treatments, as well as age and mobility issues, which significantly reduced their activity levels.

While many survivors recognized physiological benefits of increased physical activity, such as improved health and fitness, they rarely mentioned cancer-related benefits like preventing recurrence, indicating a need for targeted interventions to address these perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived barriers and benefits to physical activity in colorectal cancer patients. Fisher, A., Wardle, J., Beeken, RJ., et al.[2022]

Physical activity is beneficial for colorectal cancer survivors, as it can reduce the risk of colon cancer recurrence and improve overall quality of life and cardiovascular health, based on a review of existing data.

While the evidence for rectal cancer survivors is less strong, physical activity still shows positive effects on quality of life and health outcomes, potentially through mechanisms involving inflammation and insulin-like growth factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. Denlinger, CS., Engstrom, PF.[2021]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

A pilot trial involving 50 breast and colorectal cancer survivors showed that adding a 12-week technology-based physical activity module to standard care significantly improved physical health, mental health, sleep quality, and exercise self-efficacy.

The intervention led to moderate-to-large effect sizes in various health-related quality of life measures, suggesting that integrating technology into survivorship care plans could effectively support cancer survivors' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial. Rastogi, S., Tevaarwerk, AJ., Sesto, M., et al.[2021]

A study of 2,378 colorectal cancer survivors found that certain sociodemographic factors, like being Hispanic or non-Hispanic Black, and having multiple chronic conditions, negatively impacted compliance with recommended levels of leisure time physical activity (LTPA).

Survivors with some college education or a college degree, as well as current drinkers, were more likely to meet LTPA recommendations, highlighting the need for targeted interventions to promote physical activity among at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of leisure time physical activity compliance in colorectal cancer survivors. D'Andrea, AP., Fernandez, CA., Tannenbaum, SL., et al.[2022]

In a study of 321 colorectal cancer survivors, 57% were able to meet the recommended exercise guideline of over 150 minutes per week, highlighting the potential for regular physical activity in this population.

Key factors influencing exercise levels included personal beliefs about exercise, functional status, and environmental barriers like time constraints and weather, suggesting that tailored support from healthcare providers could enhance exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. Chou, YJ., Lai, YH., Lin, BR., et al.[2018]

In a study of 410 colorectal cancer survivors, key predictors of achieving sufficient physical activity (≥150 minutes/week) at 12 months included prior physical activity levels, unemployment status, private health insurance, and higher quality of life and post-traumatic growth.

Understanding these predictors can help create targeted public health interventions to encourage long-term physical activity among colorectal cancer survivors, ultimately improving their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of physical activity in colorectal cancer survivors after participation in a telephone-delivered multiple health behavior change intervention. Hawkes, AL., Patrao, TA., Baade, P., et al.[2021]

The eHealth intervention SurvivorCHESS led to an increase in physical activity among colon cancer survivors, with participants in the intervention group increasing their moderate to vigorous activity from 19.4 minutes to 50 minutes over 6 months, compared to a smaller increase in the control group.

Despite the initial increase in physical activity, the benefits were not sustained 3 months after the intervention ended, and there were no significant differences in quality of life or distress between the intervention and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SurvivorCHESS to increase physical activity in colon cancer survivors: can we get them moving? Mayer, DK., Landucci, G., Awoyinka, L., et al.[2021]

A self-management mobile application for colorectal cancer survivors significantly improved self-efficacy, health practices, and quality of life after six weeks of use, as shown by surveys of 39 participants.

The intervention led to specific improvements in emotional functioning and reductions in overall symptoms and fatigue, highlighting the effectiveness of mobile technology in providing social support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive coaching intervention on quality of life and psychological factors for colorectal cancer survivors: A single group pre and posttest design. Yoon, J., Lee, H., Son, H.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10561599/

Optimizing intervention tools to improve nutrition and ... The American Cancer Society (ACS) Nutrition and Physical Activity Guidelines are associated with longer survival among CRC survivors.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05056077

Improving Nutrition and Physical Activity for Cancer ... This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560161/

Physical Activity Interventions for Colorectal Cancer Survivors We provided evidence that PA interventions were effective in improving disease-specific quality of life, PA level, and maximum amount of oxygen.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1462388914001355

Diet and physical activity intervention in colorectal cancer ... Study completion rate was high (79%), and completers evaluated the intervention favourably. Significant improvements were observed in objectively-measured ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21719

American Cancer Society nutrition and physical activity ... The overall 5-year relative survival rate for all cancers combined is now 68%, and there are over 16.9 million survivors in the United ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6717629/

Impact of physical activity and diet on colorectal cancer ... Devin et al. reported that, for CRC survivors, high-intensity exercise comprises a safe, effective, and feasible intervention, because of the ...

7. facingourrisk.org facingourrisk.org/research-clinical-trials/study/171/tools-to-be-fit-tools-to-improve-nutrition-and-physical-activity-for-colorectal-cancer-survivors

Tools To Be Fit: Tools to Improve Nutrition and Physical ... Tools To Be Fit is a study to figure out what tools work best for helping cancer survivors improve their diet and exercise.