Health Promotion Tools for Colorectal Cancer Survivors

(TTBF Trial)

Recruiting at 1 trial location

Overseen By Paige Steiding

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

Trial Summary

What is the purpose of this trial?

This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with a history of cancer adopt recommended health behaviors after they have completed treatment.

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.

What data supports the effectiveness of the treatment Tools To Be Fit, Nutrition and Physical Activity Intervention for Cancer Survivors?

Research shows that physical activity can improve quality of life and psychological well-being in colorectal cancer survivors. Additionally, technology-supported interventions have been effective in increasing physical activity and improving health-related quality of life in cancer survivors. ^{1 2 3 4 5}

Is the Health Promotion Tools treatment safe for colorectal cancer survivors?

The research suggests that physical activity interventions, like those in the Health Promotion Tools, are generally safe for colorectal cancer survivors and can improve their quality of life and health outcomes. ^{2 4 6 7 8}

How is the 'Tools To Be Fit' treatment different from other treatments for colorectal cancer survivors?

The 'Tools To Be Fit' treatment is unique because it focuses on increasing physical activity and improving nutrition specifically for colorectal cancer survivors, which can help reduce the risk of cancer recurrence and improve overall health. Unlike traditional treatments that may focus on medication or surgery, this approach emphasizes lifestyle changes to enhance quality of life and health outcomes. ^{1 6 9 10 11}

Research Team

Erin Van Blarigan, ScD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Condition XVI (study booklet) 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.

Group II: Condition XV (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. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group III: Condition XIV (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. Patients receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

Group IV: Condition XIII (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 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group V: Condition XII (health kit) 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.

Group VI: Condition XI (health kit, 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 use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group VII: Condition X (health kit, health 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 use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

Group VIII: Condition VIII (text) 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.

Group IX: Condition VII (text, 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 for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group X: Condition VI (text, health 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 for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

Group XI: Condition V (text, health coach, support coach) Experimental Treatment 7 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 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group XII: Condition IX (health kit, health coach, support coach) Experimental Treatment 7 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 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group XIII: Condition IV (text, health kit) 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.

Group XIV: Condition III (text, health kit, support coach) Experimental Treatment 7 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 30-45 minutes each, approximately every 12 weeks for 48 weeks.

Group XV: Condition II (text, health kit, health coach) Experimental Treatment 7 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 15 health coaching sessions over 30-45 minutes each for 48 weeks.

Group XVI: Condition I (text, health kit, health coach, support coach) Experimental Treatment 8 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 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Perceived barriers and benefits to physical activity in colorectal cancer patients. [2022]

2. England 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. [2023]

3. Scotland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

SurvivorCHESS to increase physical activity in colon cancer survivors: can we get them moving? [2021]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Correlates of leisure time physical activity compliance in colorectal cancer survivors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of physical activity in colorectal cancer survivors after participation in a telephone-delivered multiple health behavior change intervention. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. [2018]

11. England 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. [2020]