Exercise and Cognitive Rehabilitation for Cancer Survivors

(E-Co Trial)

Overseen By Kah Poh Loh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Physical, psychological, social impairments

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mobile app called E-Co, which combines exercise and brain training to assist cancer survivors experiencing memory or thinking issues after treatment. The main goal is to determine the feasibility of this approach and its effectiveness in improving cognitive abilities. It targets survivors aged 60 and above who have completed curative cancer treatments, including those still on hormone therapies. Participants must be able to walk a short distance and speak English. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance cognitive health for cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, patients on endocrine therapies are allowed to enroll, suggesting that some medications may be continued.

What prior data suggests that this intervention is safe for cancer survivors?

Research suggests that exercise might improve brain function after cancer treatment. Some studies have explored exercise's effects on cancer survivors and found it may lower cancer risk and enhance certain brain functions.

However, the safety of exercise programs for cancer survivors remains unclear. The Exercise Harms Reporting Method (ExHaRM) aims to better understand any risks. Currently, solid information on negative effects from these exercises is limited.

Overall, exercise appears promising for addressing thinking and memory issues after cancer treatment. More research is needed to confirm the safety of these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the E-Co treatment because it uniquely combines physical exercise with cognitive rehabilitation in a single intervention for cancer survivors. Unlike typical treatments that might focus solely on physical recovery or mental health separately, E-Co integrates a mobile health exercise program with a cognitive rehabilitation strategy. This innovative approach targets both body and mind, aiming to enhance overall quality of life and cognitive function simultaneously. By addressing these areas together, E-Co has the potential to offer more comprehensive support than traditional options.

What evidence suggests that the E-Co intervention is effective for improving cognition in cancer survivors?

Research shows that exercise can improve brain function in cancer survivors. Studies have found that aerobic exercise, such as walking or cycling, boosts thinking and memory after cancer treatment. Specifically, high-intensity interval training, involving short bursts of intense exercise, has been linked to positive changes in brain structure and function. This trial will evaluate the E-Co intervention, which combines exercise with cognitive rehabilitation, including mental exercises to enhance brainpower. Early evidence suggests that this combined approach may help cancer survivors regain cognitive abilities more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for cancer survivors aged 60 or older who can walk, have finished their main cancer treatments, and may still be on hormone therapy. They should not have any health issues that make exercise risky, as decided by their oncologist. Participants must speak English and score ≤10 on a cognitive impact scale.

Inclusion Criteria

I have finished treatments aimed at curing my condition.

No medical contraindications for exercise per oncologist

I am currently on hormone therapy.

Exclusion Criteria

Physical, psychological, or social impairments that would interfere with patient's ability to participate in the study or participate in the intervention, as determined by the PIs and oncology team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a combined mobile health exercise and cognitive rehabilitation intervention

12 weeks

10 workshops (in-person or virtual)

Follow-up

Participants are monitored for cognitive outcomes and intervention feasibility

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E-Co

Trial Overview The study is testing 'E-Co,' a mobile health program combining physical exercise with cognitive rehabilitation to see if it helps improve brain function in older adults who've survived cancer.

How Is the Trial Designed?

Group I: E-Co Experimental Treatment 1 Intervention

The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).

E-Co is already approved in United States for the following indications:

Approved in United States as E-Co for:

• Cognitive rehabilitation in older cancer survivors

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

This study will evaluate the impact of a 3-month physical activity intervention on cognitive functioning in 80 sedentary breast cancer survivors who report cognitive difficulties, comparing results to a waitlist control group.

The research aims to uncover not only changes in neuropsychological outcomes and cognitive concerns but also the biological mechanisms behind these effects by analyzing biomarkers related to brain health and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of increasing physical activity on cognitive functioning in breast cancer survivors: Rationale and study design of Memory & Motion. Hartman, SJ., Natarajan, L., Palmer, BW., et al.[2022]

The I Can! study will assess the effects of a 6-month physical activity intervention on cognitive function in 250 breast cancer survivors who report cognitive difficulties, aiming to improve processing speed and self-reported cognition.

This randomized controlled trial will not only measure immediate cognitive improvements at 3 and 6 months but also evaluate the long-term maintenance of these effects at 12 months, potentially providing valuable insights for improving the quality of life for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of physical activity for cognitive functioning in breast cancer survivors: Rationale and study design of I Can! Improving Cognition After Cancer. Hartman, SJ., Weiner, LS., Natarajan, L., et al.[2023]

The STAY Fit Trial is a pilot study involving 75 adult cancer survivors that aims to compare the effects of 12 weeks of yoga, aerobic walking, and stretching on cognitive function and quality of life.

This trial will help determine which type of exercise is most effective in improving cognitive function and cardiovascular fitness in cancer survivors, potentially addressing cognitive impairments caused by cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial. Gothe, NP., Erlenbach, ED., Streeter, SL., et al.[2021]

Recruitment rates for exercise trials among cancer survivors are generally low, with a median rate of 38%, and vary by cancer type, with prostate cancer trials showing the highest rates at 45.9%.

Common barriers to participation include lack of interest, transportation issues, and failure to make contact, highlighting the need for improved recruitment strategies to enhance participation in these beneficial exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment rates and strategies in exercise trials in cancer survivorship: a systematic review. Reynolds, SA., O'Connor, L., McGee, A., et al.[2023]

An 8-week Internet-based tailored exercise program significantly improved functional capacity, as measured by the 6-minute walk test, in breast cancer survivors compared to usual care, with effects maintained at a 6-month follow-up.

The exercise program also enhanced cognitive performance, evidenced by improved recall in cognitive tests, indicating that telehealth interventions can effectively support recovery in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Galiano-Castillo, N., Arroyo-Morales, M., Lozano-Lozano, M., et al.[2019]

Older breast cancer survivors (n = 395) reported significantly less physical activity compared to women without cancer (n = 374), indicating a potential area for intervention to improve their overall health.

While higher physical activity levels in survivors were associated with better cognitive function at 12 months, this relationship did not predict future physical activity or cognitive improvements, suggesting that while they are linked, one does not necessarily drive the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Examination of the Longitudinal Relationship Between Cognitive Function and Physical Activity Among Older Breast Cancer Survivors in the Thinking and Living With Cancer Study. Tometich, DB., Mosher, CE., Cyders, M., et al.[2023]

A Web-based cognitive rehabilitation program (eReCog) showed promise in reducing self-reported cognitive impairment in adult cancer survivors, with 76 participants involved in the study over a 4-week period.

The intervention group reported fewer memory failures in daily activities compared to the waitlist control group, suggesting potential benefits for cognitive functioning, although further research is needed to explore the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial. Mihuta, ME., Green, HJ., Shum, DHK.[2019]

The pilot study demonstrated that a web-based intervention for cancer survivors was feasible and acceptable, with no reported safety concerns or injuries during the 12-week trial involving 85 participants.

While the intervention did not show statistically significant changes in physical activity or sedentary time compared to the control group, participants in the intervention group reported increased activity and decreased sedentary time, suggesting potential benefits that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of Feasibility, Acceptability, and Preliminary Efficacy of a Web-Based Physical Activity and Sedentary Time Intervention for Survivors of Physical Inactivity-Related Cancers. Rees-Punia, E., Leach, CR., Westmaas, JL., et al.[2023]

Only 23% of breast, prostate, and colorectal cancer survivors in Nova Scotia meet the recommended strength exercise guidelines of two or more days per week, indicating a need for increased physical activity among this population.

Younger age, higher education, better income, and perceived health were associated with a higher likelihood of meeting strength exercise guidelines, suggesting that targeted interventions could help improve exercise participation among those at higher risk of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and correlates of strength exercise among breast, prostate, and colorectal cancer survivors. Forbes, CC., Blanchard, CM., Mummery, WK., et al.[2022]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

A 10-week multi-modal exercise rehabilitation program is being evaluated for its feasibility among 40 deconditioned cancer survivors in Ireland, focusing on recruitment, adherence, and compliance.

The study aims to assess improvements in physical function and quality of life, highlighting the potential of exercise interventions as essential components of survivorship care for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of implementing an exercise programme for deconditioned cancer survivors in a national cancer centre: FIXCAS Study. Devenney, K., Murphy, N., Ryan, R., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.544

The Exercise Cancer and Cognition (ECCO) study. The ECCO study aimed to assess the neuropsychological and brain morphological effects of high-intensity interval training (HIIT) in breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8990905/

Protocol for the Exercise, Cancer and Cognition – The ECCO ... Epidemiological studies show that increased physical activity is linked to a lower risk of breast cancer and mortality.

3. withpower.com withpower.com/trial/phase-older-cancer-survivors-any-cancer-aged-60-and-over-have-completed-curative-intent-treatments-6-2022-f8ab7

Exercise and Cognitive Rehabilitation for Cancer Survivors ... The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40659404/

Enhancing cognitive function in breast cancer survivors ... Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04027400?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(CANCER%20NOT%20myeloma%20NOT%20leukemia))&rank=3

Effects of Computer-Assisted Cognitive Rehabilitation ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06623097

Exercise and Nutrition for Older Cancer Survivors ... This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5975081/

Exercise as an Intervention to Mitigate Decreased Cognitive ... The evidence shows promising trends for the use of exercise as a potential intervention for improving cognitive function following cancer and cancer treatment.