Telephone-Based Exercise for Colorectal and Breast Cancer

(AACT Trial)

Not currently recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Herceptin, Tamoxifen, Aromatase inhibitors

Disqualifiers: Metastatic cancer, Uncontrolled illness, BMI >47, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether phone consultations with an exercise specialist can help breast and colorectal cancer survivors become more active after chemotherapy. The goal is to determine if increased physical activity can reduce cancer recurrence and improve mood, energy, fitness, and weight. Participants will either begin a 16-week exercise program immediately or after a 16-week waiting period. Those who had stage I-III breast or colorectal cancer and completed chemotherapy between 2 and 36 months ago may be suitable, especially if they are not currently very active. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery and long-term health for cancer survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that breast cancer patients can continue adjuvant herceptin and/or tamoxifen/aromatase inhibitor therapy.

What prior data suggests that this telephone-based exercise intervention is safe for cancer survivors?

Research has shown that exercise programs, like the one in this trial, are usually safe for cancer survivors. Studies have found that regular exercise can help reduce side effects such as fatigue. One study with a similar phone-based exercise program found that participants increased their physical activity without major issues.

Another review found that telehealth exercise programs for cancer recovery improved fitness and activity levels, with no major safety concerns. This suggests that the phone-based exercise program in this study should be well-tolerated.

Overall, exercise is considered safe for most cancer survivors when done carefully and with guidance. Participants can expect a safe experience and may see positive health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telephone-based exercise intervention for colorectal and breast cancer because it offers a unique approach to patient care. Unlike traditional treatments that often focus on medication or invasive procedures, this method emphasizes physical activity through a convenient and accessible format—over the phone. This approach has the potential to improve patients' quality of life by promoting exercise without requiring them to visit a clinic or gym, making it particularly beneficial for those with limited mobility or access to healthcare facilities. Moreover, the intervention could help enhance overall health outcomes by integrating exercise into daily routines, which is known to have numerous benefits, including boosting energy levels and improving mood.

What evidence suggests that this telephone-based exercise intervention is effective for increasing physical activity in breast and colorectal cancer survivors?

Research shows that staying active after a cancer diagnosis can improve health for breast and colorectal cancer survivors. This trial will compare two groups: one will immediately participate in a 16-week telephone-based exercise program, while the control group will receive an exercise plan after a 16-week control period. Studies have found that phone-based exercise programs can significantly increase exercise levels and improve fitness. A review of several studies has shown that telehealth for exercise can enhance heart and lung fitness, which is crucial for overall health. In one study, participants in phone-based rehabilitation reported increased daily activity. These findings suggest that a program with phone calls from exercise specialists might help survivors become more active, potentially improving their health and well-being. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

The AACT is for adults over 18 who've had stage I-III breast or colorectal cancer and finished their main treatments, except certain ongoing therapies for breast cancer. They should be medically cleared for unsupervised exercise, speak English, and not be very active currently. Those with serious health issues, metastatic cancer, upcoming major surgeries or extremely high BMI are excluded.

Inclusion Criteria

My cancer is in the early to mid-stages and confirmed by tissue analysis.

My doctor says I can do moderate exercise on my own.

I haven't had major surgery in the last 2 months and don't plan any soon.

Exclusion Criteria

My cancer has spread to other parts of my body.

I plan to have a hip or knee replacement within the next year.

I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telephone-based counseling intervention to increase physical activity for 16 weeks

16 weeks

Weekly phone calls

Control

Control group receives exercise plan after a 16-week control period

16 weeks

Follow-up

Participants are monitored for changes in mood, fatigue, fitness, fat distribution, and weight

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telephone-Based exercise intervention

Trial Overview This trial tests if a phone-based counseling program can boost physical activity in people who have completed chemotherapy for breast or colorectal cancer. It involves talking to an exercise specialist regularly to see if it helps increase exercise levels and improve mood, fatigue, fitness, body fat distribution and weight.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Immediate participation in a 16-week exercise program

Group II: 2 Active Control 1 Intervention

Control population; will receive exercise plan after 16-week control period

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

Published Research Related to This Trial

A home-based physical activity intervention for colorectal cancer survivors significantly increased physical activity levels and aerobic fitness over 12 months, particularly at the 3-month mark, compared to a control group.

The intervention also improved motivational readiness for physical activity at 3 months, although no significant differences were observed in fatigue, physical functioning, or quality of life between the groups over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based physical activity intervention for colorectal cancer survivors. Pinto, BM., Papandonatos, GD., Goldstein, MG., et al.[2022]

In the CAN-HOPE trial involving 69 colorectal cancer survivors, participants reported not meeting the minimum exercise guidelines in 39.2% of the weeks, highlighting significant challenges in adherence to exercise recommendations.

The most common barriers to exercise included lack of time, treatment side effects, and fatigue, which accounted for 70% to 80% of missed exercise weeks, suggesting targeted interventions could help improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. Courneya, KS., Friedenreich, CM., Quinney, HA., et al.[2022]

The pilot study involving 7 colorectal cancer survivors showed that a 12-week mHealth home-based exercise intervention was highly feasible, with an 88.6% workout completion rate and 100% retention, indicating strong participant engagement.

Participants reported improved quality of life and expressed a desire for more intense workouts, suggesting that the intervention was not only safe (with no adverse events) but also positively received, particularly the moderate-intensity continuous exercise (MICE) approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. Moraitis, AM., Rose, NB., Johnson, AF., et al.[2023]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

A pilot study involving 30 colorectal cancer patients showed that exercise training after adjuvant chemotherapy is feasible and safe, with patients achieving significant improvements in physical performance, weight loss, and body fat reduction over one year.

Despite the positive outcomes, compliance was a major issue, with 33.3% of participants dropping out due to non-compliance, highlighting the need for strategies to enhance adherence in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients. Piringer, G., Fridrik, M., Fridrik, A., et al.[2019]

A 12-week supervised exercise program for colorectal cancer survivors was found to be feasible, with a high adherence rate of 91% and a completion rate of over 93% for assessments, indicating strong participant engagement.

The program significantly improved health-related physical fitness, including increases in peak oxygen uptake and body strength, as well as reductions in waist circumference and body fat, which may enhance quality of life and survival for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. Sellar, CM., Bell, GJ., Haennel, RG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3353544/

Impact of a Telephone-Based Physical Activity Intervention ... Observational studies demonstrate an association between physical activity and improved outcomes in breast and colon cancer survivors.

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12348-w

Effect of exercise-based cancer rehabilitation via telehealth This meta-analysis showed that telehealth exercise cancer rehabilitation could significantly increase cardiorespiratory fitness and physical activity levels ...

3. nature.com nature.com/articles/s41598-024-83846-x

Telemedicine-based exercise intervention in cancer survivors This two-armed, non-randomized, controlled intervention study for CS aims to investigate whether a telemedicine-based exercise intervention is as effective as ...

4. mhealth.jmir.org mhealth.jmir.org/2019/1/e10918/

Breast, Prostate, and Colorectal Cancer Survivors ... Background: Physical activity (PA) can improve a range of outcomes following a cancer diagnosis. These include an improvement in experience ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816689

Telephone-Based Rehabilitation Intervention to Optimize ... In this randomized clinical trial that included 284 women, the intervention resulted in significantly greater improvements in self-selected activity ...