Nutrition and Physical Activity Counseling for Breast Cancer

Overseen By Elizabeth Stone, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must be taking: Hormonal therapy

Disqualifiers: Metastatic disease, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore an easier way for breast cancer survivors to lose weight and improve fitness. It tests a personalized program combining in-person and phone-based nutrition and exercise guidance. The main goal is to determine if this approach can help survivors who are overweight and have stage 0-III breast cancer. Good candidates have a BMI over 25, have completed active cancer treatment, and are open to trying exercise and diet changes. As an unphased trial, participants contribute to innovative research that may enhance the quality of life for breast cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants currently taking hormonal therapy, like SERMS or aromatase inhibitors, can still join the study.

What prior data suggests that this counseling program is safe for breast cancer survivors?

Research has shown that both in-person and phone counseling can aid in weight loss and improve health. For example, studies have found that these methods can reduce levels of C-reactive protein, an indicator of inflammation in the body.

No harmful side effects have been reported from the nutrition and exercise counseling itself. The program involves discussions with a registered dietitian about food and exercise, which is generally safe and well-received.

Many participants find these counseling sessions helpful and engaging. This suggests that the approach is not only safe but can also lead to positive lifestyle changes for breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Individualized Nutrition and Physical Activity Counseling Program for breast cancer because it offers a personalized approach that is different from standard treatment options like chemotherapy, surgery, and radiation. This program provides one-on-one consultations with a registered dietitian, tailoring nutrition and exercise plans specifically to the individual needs of each participant. Unlike traditional treatments that primarily target the cancer itself, this program focuses on improving overall well-being and potentially enhancing treatment outcomes by promoting healthy lifestyle changes. This holistic approach could lead to better quality of life and long-term health benefits for individuals undergoing breast cancer treatment.

What evidence suggests that this counseling program is effective for breast cancer survivors?

Research shows that both in-person and phone counseling can aid in weight loss. Studies have also found that these methods can lower C-reactive protein levels, indicating reduced inflammation in the body. One study demonstrated that workplace counseling significantly increased physical activity and improved heart and lung fitness. This suggests that personalized advice on diet and exercise can help breast cancer survivors manage their weight and enhance their overall health. These findings support the use of individualized counseling, such as the Individualized Nutrition and Physical Activity Counseling Program in this trial, to promote healthier lifestyles. ^{1 2 3 6 7}

Who Is on the Research Team?

Elizabeth Stone, MD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors with a BMI of 25 or higher, at stages 0-III. They must understand and agree to the study's terms, be in good health as per ECOG scale (0 or 1), and be under care at Maroone Cancer Center. Participants should be able to attend nutrition counseling there and do exercise testing if cleared by their oncologist.

Inclusion Criteria

Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center

Participants must have the ability to understand and the willingness to sign a written informed consent document

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have never had breast cancer before.

Body mass index below 25kg/m2

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individualized nutrition and physical activity counseling, including initial in-person consults and monthly telephone follow-ups

6 months

Initial in-person consult, monthly telephone consults

Follow-up

Participants are monitored for changes in body weight, composition, cardiovascular function, and quality of life

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Nutrition and Physical Activity Counseling Program

Trial Overview The study tests an individualized program combining in-person and phone-based advice on diet and exercise tailored for overweight breast cancer survivors. It aims to see if this approach helps them lose weight without needing frequent travel for sessions.

How Is the Trial Designed?

Group I: Individualized, nutrition and physical activity intervention Experimental Treatment 1 Intervention

Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

A study involving 192 women who completed treatment for breast cancer showed that adding 3 months of telephone counseling to healthcare provider advice significantly increased moderate-intensity physical activity by about 30 minutes per week at both 3 and 6 months.

Participants receiving telephone counseling were more than twice as likely to meet the recommended physical activity guidelines of at least 150 minutes per week compared to those in the control group, and they also showed greater improvements in motivational readiness for physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to promote physical activity among breast cancer patients. Pinto, BM., Papandonatos, GD., Goldstein, MG.[2022]

Both group nutrition counseling (GNC) and individualized nutrition prescription (INP) were effective in reducing body mass, body fat percentage, and total caloric intake among 74 overweight or obese women over a 12-week period, indicating both methods can improve physical health.

Participants in both intervention groups also experienced reductions in body dissatisfaction and anxiety, suggesting that these dietary interventions can positively impact mental health as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Nutrition Counseling or Individualized Prescription for Women With Obesity? A Clinical Trial. Bolognese, MA., Franco, CB., Ferrari, A., et al.[2023]

A study involving 299 employees showed that individual counseling at the workplace significantly improved physical activity levels, cardiorespiratory fitness, and reduced body fat percentage over a 9-month period.

While the counseling was effective in enhancing certain fitness metrics, it did not significantly impact overall body mass index or the proportion of individuals meeting public health recommendations for moderate-intensity physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of individual counseling on physical activity fitness and health: a randomized controlled trial in a workplace setting. Proper, KI., Hildebrandt, VH., Van der Beek, AJ., et al.[2019]

Intensive individualized nutritional counseling for cancer patients is essential and should be conducted by nutrition professionals with specific oncology experience to ensure effective dietary management.

Nutritional supplements may be necessary when patients cannot meet their nutritional needs through regular foods, and these supplements should be tailored based on dietary deficits and individual patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional approaches in cancer: relevance of individualized counseling and supplementation. Ravasco, P.[2015]

Telephone-based counseling significantly improves fruit and vegetable consumption (effect size=0.41) and reduces dietary fat intake (effect size=0.22) compared to usual care, based on a review of nine randomized-controlled trials.

The intervention was particularly effective for women at high risk for cancer, and it also showed potential benefits in improving blood lipid levels and weight, suggesting it could be a valuable complement to traditional dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-based counseling improves dietary fat, fruit, and vegetable consumption: a best-evidence synthesis. Vanwormer, JJ., Boucher, JL., Pronk, NP.[2007]

A systematic review of 16 randomized controlled trials involving 2684 participants found that technology-supported self-guided nutrition and physical activity interventions can lead to short-term improvements in physical activity levels, fatigue, and some dietary behaviors in cancer patients.

While some studies reported significant benefits in health-related quality of life (HRQoL) and dietary quality, the overall evidence for long-term benefits of these interventions remains insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Supported Self-Guided Nutrition and Physical Activity Interventions for Adults With Cancer: Systematic Review. Kiss, N., Baguley, BJ., Ball, K., et al.[2020]

Only about 20% of family practice residents consistently ask their patients about nutrition and physical activity, indicating a gap in counseling practices that could impact cancer risk and prognosis.

Perceived effectiveness of counseling significantly influences residents' likelihood to assess and provide nutrition and physical activity advice, highlighting the need for improved training and resources to enhance these counseling practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity counseling practices of family practice residents. Guo, JL., Gottlieb, NH., Smith, MM., et al.[2015]

In a study of 100 breast cancer survivors, both in-person and telephone weight loss counseling led to significant weight loss (6.4% and 5.4%, respectively) compared to usual care (2.0%), indicating that these counseling methods are effective for weight management.

Participants in the counseling groups also experienced a notable 30% reduction in C-reactive protein levels, a marker of inflammation, suggesting that weight loss interventions may have additional health benefits for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial Comparing Telephone Versus In-Person Weight Loss Counseling on Body Composition and Circulating Biomarkers in Women Treated for Breast Cancer: The Lifestyle, Exercise, and Nutrition (LEAN) Study. Harrigan, M., Cartmel, B., Loftfield, E., et al.[2022]

In a study of 192 women who completed treatment for breast cancer, engaging in at least 150 minutes of moderate-intensity physical activity per week was linked to improved physical functioning and quality of life after 3 months.

Sustaining this level of physical activity for at least 6 months led to significant reductions in fatigue and further improvements in physical functioning and quality of life, highlighting the importance of long-term exercise for psychosocial benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and psychosocial benefits among breast cancer patients. Pinto, BM., Dunsiger, S., Waldemore, M.[2022]

A cluster-randomized clinical trial involving 468 cancer patients receiving radiotherapy showed that an evidence-based nutrition education and counseling (NEC) program significantly improved nutrition status, as indicated by lower PG-SGA scores (5.6 vs 6.9) and reduced malnutrition rates (56.0% vs 70.5%) compared to usual care.

The study demonstrates that implementing NEC in clinical settings can effectively reduce malnutrition among cancer patients undergoing treatment, highlighting its potential as a standard practice in radiotherapy units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. Zhang, Z., Zhu, Y., Zhang, L., et al.[2022]

The patient-centered counseling model improves long-term dietary adherence by personalizing interventions based on individual patient needs and stages of change.

This model includes a 4-step counseling process that helps nutrition professionals effectively support patients in following nutrition care plans and dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. Rosal, MC., Ebbeling, CB., Lofgren, I., et al.[2022]

A 2-week intervention involving adapted physical activity and nutritional education significantly improved the quality of life (QoL) of 251 breast cancer patients post-chemotherapy, with benefits persisting for up to 5 years.

The intervention also led to sustained weight control for 2 years, with a notable decrease in weight and waist circumference, indicating long-term health benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term improvement of breast cancer survivors' quality of life by a 2-week group physical and educational intervention: 5-year update of the 'PACThe' trial. Kwiatkowski, F., Mouret-Reynier, MA., Duclos, M., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26598750/

The Lifestyle, Exercise, and Nutrition (LEAN) Study - PubMed Both in-person and telephone counseling were effective weight loss strategies, with favorable effects on C-reactive protein levels.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04365569?tab=table

Evaluating the Effectiveness of an Individualized Nutrition ... This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program. Detailed Description. Not provided. Study ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2015.61.6375

Randomized Trial Comparing Telephone Versus In-Person ... Both in-person and telephone counseling were effective weight loss strategies, with favorable effects on C-reactive protein levels. Our findings ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-2021-10af4

Nutrition and Physical Activity Counseling for Breast Cancer A study involving 299 employees showed that individual counseling at the workplace significantly improved physical activity levels, cardiorespiratory fitness, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4872022/

The Lifestyle, Exercise, and Nutrition (LEAN) Study Both in-person and telephone counseling were effective weight loss strategies, with favorable effects on C-reactive protein levels. Our findings ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-13837

A Nutrition and Exercise Counseling Program to Assist ... This clinical trial investigates whether an individualized counseling program with a registered dietician may help stage 0-III breast cancer survivors reach ...

7. nature.com nature.com/articles/s41523-024-00659-x

Evaluation of a mobile behavior change program for weight ... In this study, breast cancer survivors were highly engaged with a behavioral change smartphone application which led to clinically significant weight loss.