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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Individualized Nutrition and Physical Activity Counseling Program for breast cancer?

Research shows that physical activity and nutritional education can improve the quality of life and prognosis for breast cancer patients. Telephone and in-person counseling have been effective in promoting physical activity and weight loss, which are beneficial for breast cancer outcomes. ^{1 2 3 4 5}

Is the Nutrition and Physical Activity Counseling Program safe for humans?

The Nutrition and Physical Activity Counseling Program, including telephone-based and in-person counseling, has been studied for its effects on diet and physical activity. These studies have shown improvements in dietary habits, body composition, and some mental health parameters without reporting any significant safety concerns, suggesting it is generally safe for humans. ^{4 6 7 8 9}

How is the Individualized Nutrition and Physical Activity Counseling Program different from other treatments for breast cancer?

This treatment is unique because it combines personalized nutrition and physical activity counseling, which can be delivered both in-person and via telephone, making it more flexible and accessible compared to traditional in-person counseling. It focuses on tailored interventions to improve diet and exercise habits, which are crucial for managing breast cancer outcomes. ^{2 4 10 11 12}

What is the purpose of this trial?

More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

Research Team

Elizabeth Stone, MD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity and psychosocial benefits among breast cancer patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized trial to promote physical activity among breast cancer patients. [2022]

3. England 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. [2018]

4. United States 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Telephone-based counseling improves dietary fat, fruit, and vegetable consumption: a best-evidence synthesis. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Group Nutrition Counseling or Individualized Prescription for Women With Obesity? A Clinical Trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of individual counseling on physical activity fitness and health: a randomized controlled trial in a workplace setting. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Technology-Supported Self-Guided Nutrition and Physical Activity Interventions for Adults With Cancer: Systematic Review. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity counseling practices of family practice residents. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

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