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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
Completed all neoadjuvant and adjuvant cytotoxic chemotherapy or radiation prior to enrollment (hormonal treatments for breast and prostate cancer are allowed)
Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights

TTBF Trial 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.Check my eligibility
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.See study design
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.

TTBF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have finished all my initial cancer treatments except for hormone therapy.
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I have been diagnosed with a specific type of cancer (bladder, breast, colon, endometrial, kidney, ovarian, prostate, or rectal).
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I am 18 years old or older.

TTBF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in American Cancer Society (ACS) guideline score at 48 weeks
Secondary outcome measures
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

TTBF Trial Design

16Treatment groups
Experimental Treatment
Group I: Condition XVI (study booklet)Experimental Treatment2 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 Treatment3 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 Treatment3 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 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. 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 Treatment3 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 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. 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 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. 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 Treatment3 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 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. 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 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. 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 Treatment5 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 Treatment5 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 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. Patients receive text messages and use digital health tool kit for 48 weeks.
Group XIV: Condition III (text, health kit, support coach)Experimental Treatment5 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 Treatment5 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 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 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
~4000

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER
497 Previous Clinical Trials
163,559 Total Patients Enrolled
Robert H. Lurie Cancer CenterOTHER
21 Previous Clinical Trials
797 Total Patients Enrolled
University of California, DavisOTHER
909 Previous Clinical Trials
4,703,130 Total Patients Enrolled

Media Library

Tools To Be Fit Clinical Trial Eligibility Overview. Trial Name: NCT05056077 — N/A
Kidney Cancer Research Study Groups: Condition XIV (health coach), Condition VIII (text), Condition I (text, health kit, health coach, support coach), Condition IV (text, health kit), Condition IX (health kit, health coach, support coach), Condition VI (text, health coach), Condition VII (text, support coach), Condition XV (support coach), Condition XI (health kit, support coach), Condition XII (health kit), Condition II (text, health kit, health coach), Condition III (text, health kit, support coach), Condition V (text, health coach, support coach), Condition XIII (health coach, support coach), Condition XVI (study booklet), Condition X (health kit, health coach)
Kidney Cancer Clinical Trial 2023: Tools To Be Fit Highlights & Side Effects. Trial Name: NCT05056077 — N/A
Tools To Be Fit 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056077 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available in this research program for new participants?

"Affirmative. According to information published on the clinicaltrials.gov website, this medical experiment is presently recruiting subjects. The trial was first listed in October 2021 and updated most recently in July 2022; 800 participants are required from 2 sites for the study's completion."

Answered by AI

How many individuals are enrolled in this investigation?

"Affirmative. Per clinicaltrials.gov, the trial which was uploaded on October 21st 2021 is still seeking participants. 800 patients are required at 2 separate healthcare facilities before completion of recruitment."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~608 spots leftby Dec 2027