Telephone-Based Exercise for Colorectal and Breast Cancer

(AACT Trial)

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to determine whether a telephone-based counseling intervention can help survivors of breast and colorectal cancer increase their weekly physical activity. Observational evidence suggests that physical activity after breast and colorectal cancer diagnosis decreases recurrence rates. Unfortunately, many people become less active during cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical activity. This study looks to see if people who have recently finished chemotherapy for breast, colon or rectal cancer can be motivated to increase their exercise by talking to an exercise specialist over the phone. The study also looks at changes in mood, fatigue, fitness, fat distribution and weight.

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 data supports the effectiveness of the treatment Telephone-Based exercise intervention for colorectal and breast cancer?

Research shows that home-based and telephone-based exercise programs can improve quality of life and physical fitness in cancer survivors, including those with colorectal and breast cancer. These programs have shown promising effects on both physical and psychological well-being, suggesting they can be an effective part of cancer rehabilitation. ^{1 2 3 4 5}

Is telephone-based exercise intervention safe for cancer survivors?

Research on telephone-based exercise interventions for cancer survivors, including those with breast and colorectal cancer, suggests they are generally safe. Studies have focused on feasibility and safety, with no significant safety concerns reported in the available data. ^{1 5 6 7 8}

How is the Telephone-Based exercise intervention treatment different from other treatments for colorectal and breast cancer?

The Telephone-Based exercise intervention is unique because it provides exercise guidance and support over the phone, making it accessible and convenient for cancer survivors who may have difficulty attending in-person sessions. This approach is different from traditional treatments as it focuses on physical activity to improve health outcomes, rather than medication or surgery. ^{1 2 5 9 10}

Research Team

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Home-based physical activity intervention for colorectal cancer survivors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Physical exercise results in the improved subjective well-being of a few or is effective rehabilitation for all cancer patients? [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Systematic review of pre-operative exercise in colorectal cancer patients. [2018]

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

Phase II Feasibility Study of a Weight Loss Intervention in Female Breast and Colorectal Cancer Survivors (SWOG S1008). [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

7. Germany 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. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. [2022]

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

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. [2023]

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

Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery - A randomized controlled design. [2020]