What side effects are associated with this type of intervention?

Common treatments for cancer survivors, such as chemotherapy and radiation therapy, often result in side effects like fatigue, nausea, pain, and cognitive changes. These treatments can also lead to long-term issues such as cardiovascular problems, secondary cancers, and persistent fatigue. Exercise and nutrition interventions, like those in the Lifestyle Modification Program, aim to mitigate these side effects by improving physical function, reducing fatigue, and enhancing overall quality of life.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer survivors, but specific approvals focusing solely on lifestyle modifications like those in the Lifestyle Modification Program are less common. However, the importance of diet and physical activity in improving health outcomes for cancer survivors is well-documented. Programs that encourage adherence to the American Cancer Society's guidelines on nutrition and physical activity can significantly reduce symptoms and improve overall health. While not FDA-approved drugs, these lifestyle interventions are crucial in the long-term management of cancer survivorship.

What other types of research exist?

Promising, novel alternatives to Lifestyle Modification Programs for cancer survivors in 2024 include: 1) Telehealth-based interventions, which provide remote support and personalized guidance on diet and exercise; 2) Mobile health applications that offer tracking, reminders, and educational resources to promote healthy behaviors; 3) Integrative approaches combining physical activity with complementary therapies such as yoga or mindfulness; 4) Community-based programs that foster social support and group activities; and 5) Personalized nutrition and exercise plans based on genetic and metabolic profiling to tailor interventions to individual needs.

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Lifestyle Intervention for Cancer Survivors

N/A

Recruiting

Led By Cynthia Thomson, MD

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

Study Summary

This trial is testing an intervention to help Hispanic cancer survivors reduce symptoms and adhere to American Cancer Society guidelines for cancer prevention.

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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 13-weeks, and 25-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

Change from baseline vegetable and fruit intake at 25-weeks in survivors

Change in vegetable and fruit intake at 13-weeks in survivors

Secondary outcome measures

Physical activity

Symptom severity

Vegetable and fruit intake in caregivers

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.

Do I qualify?Apply below to find out

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.

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Who is running the clinical trial?

University of ArizonaLead Sponsor

518 Previous Clinical Trials

148,353 Total Patients Enrolled

3 Trials studying Cancer Survivors

281 Patients Enrolled for Cancer Survivors

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,238 Total Patients Enrolled

1 Trials studying Cancer Survivors

212 Patients Enrolled for Cancer Survivors

Cynthia Thomson, MDPrincipal InvestigatorUniversity of Arizona

Media Library

Symptom management and lifestyle intervention Clinical Trial Eligibility Overview. Trial Name: NCT05364372 — N/A

Cancer Survivors Research Study Groups: Symptom management and lifestyle intervention, Attention control

Cancer Survivors Clinical Trial 2023: Symptom management and lifestyle intervention Highlights & Side Effects. Trial Name: NCT05364372 — N/A

Symptom management and lifestyle intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364372 — N/A

~103 spots leftby Mar 2026

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