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Lifestyle Intervention for Cancer Survivors
N/A
Recruiting
Led By Jennifer Bea, PhD
Research Sponsored by University of Arizona
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 baseline, 13-weeks, and 25-weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a program to help Hispanic cancer survivors and their caregivers eat healthier and be more active. The goal is to reduce symptoms and improve overall health by providing support and boosting confidence.
Who is the study for?
This trial is for Hispanic cancer survivors over 18 who've finished treatment within the last year, except hormonal therapy or trastuzumab. They must have a caregiver to join with them and suffer from symptoms like pain or fatigue rated at least 4 out of 10 in severity. Participants need phone access and must understand English or Spanish.
What is being tested?
The study compares two approaches: one group will only assess their symptoms, while the other will also receive guidance on symptom management and lifestyle changes aimed at meeting nutrition and physical activity guidelines to improve health and reduce cancer risk.
What are the potential side effects?
Since this trial involves non-medical interventions such as lifestyle modifications, side effects may include discomfort from increased physical activity or dietary changes but are generally expected to be minimal compared to drug treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 13-weeks, and 25-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 13-weeks, and 25-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline vegetable and fruit intake at 25-weeks in survivors
Change in vegetable and fruit intake at 13-weeks in survivors
Secondary study objectives
Physical activity
Symptom severity
Vegetable and fruit intake in caregivers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Symptom management and lifestyle interventionExperimental Treatment1 Intervention
Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.
Group II: Attention controlActive Control1 Intervention
Dyads will receive mailed print education materials regarding healthy lifestyle (nutrition and physical activity) disseminated by ACS and NCI. They will also receive 12 weekly phone calls to assess post-treatment related symptoms.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cancer survivors, particularly those involving lifestyle modifications, focus on diet and physical activity. These interventions work by improving metabolic health, reducing inflammation, and enhancing immune function.
A healthy diet rich in fruits, vegetables, and whole grains can provide essential nutrients and antioxidants, while regular physical activity helps maintain a healthy weight and improves cardiovascular health. These mechanisms are vital for cancer survivors as they can reduce the severity of treatment-related side effects, lower the risk of cancer recurrence, and improve overall quality of life.
Coordination of care among healthcare professionals ensures that survivors receive comprehensive support tailored to their individual needs.
Breast Cancer: A Lifestyle Medicine Approach.
Breast Cancer: A Lifestyle Medicine Approach.
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Who is running the clinical trial?
University of ArizonaLead Sponsor
536 Previous Clinical Trials
159,723 Total Patients Enrolled
3 Trials studying Cancer Survivors
469 Patients Enrolled for Cancer Survivors
American Cancer Society, Inc.OTHER
231 Previous Clinical Trials
109,494 Total Patients Enrolled
1 Trials studying Cancer Survivors
400 Patients Enrolled for Cancer Survivors
Jennifer Bea, PhDPrincipal InvestigatorUniversity of Arizona
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18, finished cancer treatment over a year ago, and have a caregiver willing to join.I am a Hispanic female cancer survivor, over 18, with a caregiver, and have had severe cancer symptoms.I am over 18, speak English or Spanish, have a phone, and am not being treated for cancer.I am a caregiver under 18, without phone access, not in diet counseling or cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Symptom management and lifestyle intervention
- Group 2: Attention control
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.
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