Exercise Promotion for Breast Cancer Survivors

Overseen By Hollin R Hakimian, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Antipsychotics, Anticonvulsants, Lithium

Disqualifiers: Pregnancy, Severe mental illness, others

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

Compensation: Varies

Number of Visits: 6

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are: 1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking mood stabilizing medications like antipsychotics, anticonvulsants, or lithium, you may not be eligible to participate.

Is the exercise promotion intervention safe for breast cancer survivors?

The ACTIVATE Trial, which used wearable technology to encourage physical activity in breast cancer survivors, did not report any safety concerns, suggesting that the intervention is generally safe for this group. ^{1 2 3 4 5}

How does the Core Exercise Promotion Intervention treatment differ from other treatments for breast cancer survivors?

The Core Exercise Promotion Intervention is unique because it focuses on promoting physical activity among breast cancer survivors, using behavior change techniques to improve exercise adherence and health outcomes. Unlike standard treatments that may focus on medication or surgery, this intervention aims to enhance physical activity through structured programs and support, potentially improving overall well-being and reducing fatigue. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Core Exercise Promotion Intervention for breast cancer survivors?

Research shows that physical activity provides numerous health benefits for cancer survivors, improving both patient-reported outcomes and physiological health during and after cancer therapy. Additionally, a motivational program for women after breast cancer has been shown to increase physical activity levels 12 months post-rehabilitation. ^{8 9 10 11 12}

Who Is on the Research Team?

Courtney Stevens, PhD

Principal Investigator

Dartmouth-Hitcock Health

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who finished their primary treatment within the last 5 years. Participants should be interested in increasing physical activity and willing to wear an activity monitor and answer surveys at specified times.

Inclusion Criteria

Access to internet to complete REDCap survey assessments

<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6 months

I own a smartphone or tablet and agree to use it for surveys.

Exclusion Criteria

Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)

Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)

Non-English speaking/not able to read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assigned to either the Affect-based or Effort-based exercise prescription and participate in initial meetings to increase weekly exercise

1 week

2 visits (in-person)

Exercise Intervention

Participants follow their assigned exercise prescription and wear an activity monitor, responding to surveys at specified intervals

12 weeks

4 survey points (Baseline, 2 weeks, 6 weeks, 12 weeks)

Follow-up

Participants are monitored for changes in physical activity, depressive symptoms, and other health measures

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core Exercise Promotion Intervention

Trial Overview The study tests two exercise prescriptions: one based on affect (how exercises make you feel) and another on effort. It measures how much moderate-to-vigorous exercise participants do, their satisfaction with the program, and retention rates over a 12-week period.

How Is the Trial Designed?

Group I: Affect-based Exercise Prescription (Affect-Rx) Experimental Treatment 2 Interventions

Group II: Effort-based Exercise Prescription (RPE-Rx) Active Control 2 Interventions

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Both breast cancer survivors and healthcare providers agree that exercise counseling is an important part of cancer care, highlighting a shared belief in its benefits.

Over half of the surveyed breast cancer survivors expressed willingness to participate in structured exercise classes, while most providers supported the idea of cancer centers offering such programs, indicating a strong demand for exercise integration in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Beliefs of Older Female Breast Cancer Survivors and Providers About Exercise in Cancer Care. Perry, CK., Ali, W., Solanki, E., et al.[2021]

Breast cancer survivors with Medicaid insurance are less physically active and less likely to recognize the health benefits of exercise compared to those with non-Medicaid insurance, indicating a need for targeted support.

On-treatment and early survivors value health benefits from exercise more than late survivors, suggesting that exercise programs should be tailored to the specific needs and beliefs of survivors based on their treatment status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. Karvinen, KH., Raedeke, TD., Arastu, H., et al.[2011]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

The motivational-volitional program (MoVo-BnB) significantly increased physical activity levels in breast cancer patients, with the intervention group exercising an average of 22 minutes more per week than the control group at the 12-month follow-up.

Nearly half (49.1%) of the intervention group achieved the recommended 60 minutes of exercise per week, compared to only 37.6% in the control group, indicating the program's effectiveness in promoting long-term physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Motivational-Volitional Program for Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation - Results of a Prospective Controlled Trial]. Adams, L., Feicke, J., Eckert, T., et al.[2022]

Health care provider-delivered physical activity interventions can potentially increase physical activity behavior among cancer survivors, with nine out of eleven studies showing positive results favoring the intervention group.

However, the effectiveness of these interventions may vary and could be enhanced by incorporating additional behavior change techniques, highlighting the need for further research to better understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review summarizing the effect of health care provider-delivered physical activity interventions on physical activity behaviour in cancer survivors. Brunet, J., Wurz, A., Nader, PA., et al.[2021]

The ACTIVATE Trial demonstrated that using a Garmin Vivofit 2 activity monitor, along with behavioral coaching, significantly increased moderate to vigorous physical activity (MVPA) by an average of 69 minutes per week in breast cancer survivors over a 12-week period.

Participants in the intervention group also experienced a significant reduction in sedentary behavior, with decreases of 37 minutes per day in total sitting time and 42 minutes per day in prolonged sitting bouts, highlighting the effectiveness of wearable technology in promoting a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

Breast cancer survivors showed no significant differences in overall physical activity levels when comparing in-person cardiovascular rehabilitation (CR) to virtual CR during the COVID-19 pandemic, indicating that virtual options can maintain activity levels.

However, the variability in physical activity duration increased significantly after the transition to virtual CR, suggesting that while overall activity was maintained, the consistency of participation may have been affected, highlighting the need for tailored strategies to enhance engagement in virtual programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). Larkin, J., Vanzella, L., Thomas, S., et al.[2022]

The ACTIVATE Trial, involving 83 postmenopausal breast cancer survivors, showed that a wearable-based intervention significantly reduced fatigue levels after 12 weeks, with a notable 4.6-point improvement in fatigue scores compared to the control group.

While the intervention successfully increased physical activity and reduced sedentary behavior, it did not lead to significant improvements in health-related quality of life (HRQoL), suggesting that longer or more intensive interventions may be necessary to achieve changes in HRQoL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors. Vallance, JK., Nguyen, NH., Moore, MM., et al.[2020]

A significant portion of older cancer survivors (58.3%) do not meet recommended exercise guidelines, with frail individuals being even less likely to engage in physical activity, highlighting a need for targeted interventions.

Despite low exercise levels, many survivors (66.9%) expressed interest in exercise counselling and programs, particularly favoring low-intensity activities, indicating an opportunity to promote healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise levels and preferences on exercise counselling and programming among older cancer survivors: A mixed-methods study. Cheung, DST., Takemura, N., Chau, PH., et al.[2021]

The ACTIVATE Trial is a randomized controlled study designed to evaluate the effectiveness of a 12-week intervention using wearable technology (Garmin Vivofit2®) combined with behavioral change strategies to increase physical activity and reduce sedentary behavior in postmenopausal breast cancer survivors.

If successful, this intervention could provide a cost-effective and sustainable method for improving the health and quality of life of breast cancer survivors by promoting physical activity and reducing sitting time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial. Lynch, BM., Nguyen, NH., Reeves, MM., et al.[2019]

A systematic review of randomized controlled trials involving breast cancer survivors found that while 84% of studies applied the principle of specificity in exercise prescription, only 29% applied progression and 38% applied overload, indicating a lack of comprehensive adherence to exercise training principles.

None of the studies reported all components of the exercise prescription or participant adherence, highlighting a significant gap in the methodology that could affect the replication of results and the application of findings in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated systematic review of exercise studies in breast cancer survivors: attention to the principles of exercise training. Neil-Sztramko, SE., Winters-Stone, KM., Bland, KA., et al.[2022]

A pilot study showed that a physical activity behavior change intervention significantly improved physical activity levels and health outcomes among breast cancer survivors, indicating its potential effectiveness.

The upcoming two-site randomized controlled trial aims to recruit 256 breast cancer survivors to further assess the intervention's long-term effects and explore the mechanisms behind behavior change, with outcomes measured at multiple time points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Rogers, LQ., McAuley, E., Anton, PM., et al.[2022]

Citations

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

Attitudes and Beliefs of Older Female Breast Cancer Survivors and Providers About Exercise in Cancer Care. [2021]

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

Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. [2011]

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

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[A Motivational-Volitional Program for Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation - Results of a Prospective Controlled Trial]. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

A systematic review summarizing the effect of health care provider-delivered physical activity interventions on physical activity behaviour in cancer survivors. [2021]

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

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors. [2020]

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

Exercise levels and preferences on exercise counselling and programming among older cancer survivors: A mixed-methods study. [2021]

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

Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial. [2019]

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

Updated systematic review of exercise studies in breast cancer survivors: attention to the principles of exercise training. [2022]

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

Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. [2022]