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Health Promotion Tools for Colorectal Cancer Survivors (TTBF Trial)

N/A

Recruiting

Led By Erin Van Blarigan, ScD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effect of 4 different "tools" on weight, nutrition, and physical activity in colorectal cancer survivors. The goal is to see if these tools can help patients adopt recommended health behaviors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves non-medical approaches like education and counseling rather than drugs or medical procedures, side effects are minimal but may include potential discomfort from increased physical activity or changes in diet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in American Cancer Society (ACS) guideline score at 48 weeks

Secondary study objectives

Mean change in ACS guideline score at 24 weeks

Mean change in scores on the individual components of the ACS at 24 weeks

Mean change in scores on the individual components of the ACS at 48 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Group I: Condition XVI (study booklet)Experimental Treatment4 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 Treatment5 Interventions

Group III: Condition XIV (health coach)Experimental Treatment5 Interventions

Group IV: Condition XIII (health coach, support coach)Experimental Treatment6 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 Treatment5 Interventions

Group VI: Condition XI (health kit, support coach)Experimental Treatment6 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 Treatment6 Interventions

Group VIII: Condition VIII (text)Experimental Treatment5 Interventions

Group IX: Condition VII (text, support coach)Experimental Treatment6 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 Treatment6 Interventions

Group XI: Condition V (text, health coach, support coach)Experimental Treatment7 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 Treatment7 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 Treatment6 Interventions

Group XIV: Condition III (text, health kit, support coach)Experimental Treatment7 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 Treatment7 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 Treatment8 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education

2014

Completed Phase 3

~4410

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