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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
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
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
~4010
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterOTHER
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163,863 Total Patients Enrolled
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Robert H. Lurie Cancer CenterOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have any major surgeries planned during the study, except for minor procedures.I can speak and read English or Spanish.I have a support person over 18 who can communicate in English or Spanish and agrees to support me during the study.I have severe heart, lung, or muscle/joint issues preventing moderate exercise.I am 18 years old or older.I am not scheduled for cancer therapy during the study, except for hormone treatments for breast or prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Condition I (text, health kit, health coach, support coach)
- Group 2: Condition IX (health kit, health coach, support coach)
- Group 3: Condition XIV (health coach)
- Group 4: Condition VIII (text)
- Group 5: Condition IV (text, health kit)
- Group 6: Condition VII (text, support coach)
- Group 7: Condition XV (support coach)
- Group 8: Condition VI (text, health coach)
- Group 9: Condition XI (health kit, support coach)
- Group 10: Condition XII (health kit)
- Group 11: Condition II (text, health kit, health coach)
- Group 12: Condition III (text, health kit, support coach)
- Group 13: Condition V (text, health coach, support coach)
- Group 14: Condition XIII (health coach, support coach)
- Group 15: Condition XVI (study booklet)
- Group 16: Condition X (health kit, health coach)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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