Rehabilitation for Breast and Colorectal Cancer

Overseen By David Langelier, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Wheelchair ambulation, Severe pain, Depression, Neurological conditions, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

117 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study is a Phase II, feasibility, randomized controlled preference based study. This will be conducted in Vancouver and Toronto and includes breast and colorectal cancers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for Rehabilitation for Breast and Colorectal Cancer?

Research suggests that cancer rehabilitation, including therapies like physical and occupational therapy, can improve mental and emotional well-being and reduce anxiety in cancer patients. Additionally, remote rehabilitation programs can help overcome barriers like distance and cost, making them accessible to more patients. ^{1 2 3 4 5}

Is rehabilitation therapy safe for cancer patients?

Rehabilitation therapy, including virtual reality and other forms, is generally considered safe for cancer patients, but it requires careful planning due to the complexity of cancer and its treatments. Providers need to be aware of the potential side effects and medical conditions to ensure a safe rehabilitation process. ^{6 7 8 9 10}

How is the rehabilitation treatment for breast and colorectal cancer unique compared to other treatments?

This rehabilitation treatment is unique because it offers both in-person and virtual options, allowing for flexibility and accessibility. The virtual component, known as telerehabilitation, provides remote support and therapy, which can be especially beneficial for patients who have difficulty accessing traditional in-person services. This approach is particularly novel as it combines various therapies like physical, occupational, and speech therapy, tailored to improve quality of life and functional outcomes for cancer patients. ^{5 11 12 13 14}

Research Team

Jennifer Jones, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 with advanced, incurable breast or colorectal cancer who can walk and take care of themselves. They should be on their first or second treatment in the metastatic setting and expected to live more than 6 months. People in wheelchairs, with severe depression, unwilling to participate fully, unable to use video calls (for virtual rehab), not fluent in English, suffering from significant pain or cognitive issues affecting safety are excluded.

Inclusion Criteria

I can walk and move around on my own, with or without help like a cane.

I am on my first or second round of treatment for cancer that has spread and cannot be cured.

My doctors believe I have more than 6 months to live.

Exclusion Criteria

I do not have any brain conditions affecting my thinking or movement.

I have severe depression symptoms.

I experience moderate to severe pain from cancer in my bones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week group-based cancer rehabilitation program, either in-person or virtually, focusing on exercise and self-management skills.

8 weeks

8 visits (in-person or virtual)

Short Maintenance

A 4-week short maintenance period following the main treatment phase, continuing exercise and self-management practices.

4 weeks

Follow-up

Participants are monitored for safety, effectiveness, and physiological measures post-treatment.

3 months

Treatment Details

Interventions

• In-person rehabilitation group
• Virtual rehabilitation group

Trial Overview The study compares two types of rehabilitation programs for people with advanced cancer: one that's done in person and another that's conducted virtually. Participants will be randomly assigned to a group based on their preference and will receive either face-to-face sessions or online guidance aimed at improving their physical function.

Participant Groups

Group I: Virtual Intervention arm Experimental Treatment 1 Intervention

The virtual intervention arm will be an 8-week program plus four week short maintenance period but will include two separate 1 hour sessions per week. This includes: 1) 60 minutes of virtual, group-based, synchronous exercise over a virtual secure platform; and, 2) A separate 60 min virtual synchronous education session provided on a separate day (to prevent virtual fatigue). 3) Encouragement to participate in a home program the other days of the week, striving for the recommended 90 min of moderate to vigorous aerobic exercise and 2 days of week or resistance exercise. The virtual intervention group will combine participants across both study locations and run sessions when sufficient numbers are recruited. Self-management education content will be unchanged to the in-person sessions but conducted over a virtual platform (i.e., videoconferencing) with participants also attending virtually.

Group II: In-person Intervention arm Experimental Treatment 1 Intervention

The in-person intervention arm is an 8-week program and four week short maintenance period. This includes 1 hr of in-person, group-based exercise guided by a qualified exercise professional followed by 1 hr of in-person, group based, self-management education provided by a rehabilitation expert to occur immediately following the exercise session. Each participant is given a FitBit® to track steps, heart rate and sleep. Each site (i.e., Toronto and Vancouver) will run independent, in-person exercise and educational programs based on local referrals. Self management sessions include 8 high priority topics for advanced cancer patients including: 1) goal setting, 2) managing pain, 3) reducing fatigue and improving sleep, 4) boosting brain health, 5) eating and cooking for wellness, 6) managing emotions, 7) being mindful, and 8) planning for the future. Education sessions will be run by local experts at each site.

Group III: Standard best cancer practice Active Control 1 Intervention

All participants (intervention arms 1 and 2, and control) will receive usual oncology care by their health care providers which includes recommendations for general aerobic and resistance exercise. Participants in the control group will be of recommended to work towards the recommended 90 minutes moderate to vigorous aerobic exercise, and two days a week of large muscle group strength training as recommended by the ACSM. A general brochure will be provided to all control participants providing education in line with current standard of care. This safety precautions noted these will be indicated brochure will have an open text field on the back which will allow the kinesiologist to provide and general advice at each time point. If there are particular here. Participants in all study arms may also be referred by treating health care providers to usual supportive care or early palliative care services at any time deemed necessary, and will be recorded as part of monthly data collection.

In-person rehabilitation group is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Rehabilitation therapy for:

• Advanced cancer
• Breast cancer
• Colorectal cancer

Approved in United States as Rehabilitation therapy for:

• Cancer-related impairments
• Pain management
• Fatigue management

Approved in European Union as Rehabilitation therapy for:

• Cancer rehabilitation
• Physical impairments
• Psychological support

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Implementing electronic patient-reported outcomes (ePRO) in cancer rehabilitation can enhance the understanding of patient quality of life, as demonstrated in an Austrian inpatient center where structured steps improved participation rates.

Continuous stakeholder involvement and tailored assessment procedures were key to successfully integrating ePRO data into medical practices, such as including it in discharge letters and follow-up assessments, making the process more patient-centered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to implement routine electronic patient-reported outcome monitoring in oncology rehabilitation. Wintner, LM., Sztankay, M., Riedl, D., et al.[2021]

In a study of 165 stroke patients undergoing multidisciplinary rehabilitation, about 50.6% had their expectations of therapy fulfilled or exceeded, particularly those who had lower expectations at the start of treatment.

The likelihood of fulfilling expectations was positively associated with improvements in health-related quality of life, suggesting that managing patient expectations may play a crucial role in rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' outcome expectations and their fulfilment in multidisciplinary stroke rehabilitation. Groeneveld, IF., Goossens, PH., van Braak, I., et al.[2019]

The CaRE@Home program, an 8-week online cancer rehabilitation and exercise intervention, demonstrated high feasibility and acceptability among 35 participants, with retention and adherence rates of 83% and 80%, respectively.

Participants showed significant improvements in disability, physical activity levels, work productivity, walking distance, and grip strength, indicating that the program may effectively help cancer survivors regain functional abilities and reduce disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CaRE @ Home: Pilot Study of an Online Multidimensional Cancer Rehabilitation and Exercise Program for Cancer Survivors. MacDonald, AM., Chafranskaia, A., Lopez, CJ., et al.[2020]

Breast cancer rehabilitation can be effective for patients with different tumor locations, as long as the specifics of their primary treatment are taken into account.

This rehabilitation not only improves physical function but also enhances mental and emotional well-being, reducing anxiety and fostering a renewed interest in activities post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An experience with the rehabilitation of breast cancer patients after radical treatment]. Donskaia, LV., Demin, EV., Chulkova, VA., et al.[2006]

Cancer patients have higher expectations for their functional recovery after inpatient rehabilitation compared to cancer rehabilitation providers, with patients expecting a median Barthel Index score of 19, while providers estimated 17 (P < 0.001).

Upon discharge, the actual functional status of patients was lower than expected, with a median score of 16, indicating a significant gap between expectations and reality, suggesting that improved communication could help align these expectations more realistically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Rehabilitation Providers and Oncology Patient Expectations for Functional Outcomes after Inpatient Rehabilitation. Gupta, E., Ng, AH., Fu, JB., et al.[2021]

Virtual reality (VR) interventions significantly reduced anxiety levels in breast cancer patients, with a strong effect size, and improved the range of motion in upper limbs, indicating potential benefits for rehabilitation.

While VR showed positive effects on anxiety and upper limb mobility, it did not significantly reduce fatigue, and the overall quality of evidence is low, suggesting that more robust clinical studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality-based interventions for patients with breast cancer symptom and rehabilitation management: a systematic review and meta-analysis. Zhang, H., Xu, H., Zhang, ZX., et al.[2022]

Patient safety is a critical concern in the rehabilitation of cancer patients due to the complexity of their medical care and the long-term effects of cancer and its treatments.

As the number of cancer survivors increases, rehabilitation clinicians need to be aware of safety issues to effectively support patients during their recovery in various settings, including hospitals and outpatient facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in cancer rehabilitation. Cristian, A., Tran, A., Patel, K.[2012]

A systematic review of 11 clinical studies found that virtual reality (VR) therapy can effectively support breast cancer patients by alleviating anxiety during treatment and reducing pain, which can enhance their overall quality of life.

VR therapy also appears to improve physical functions, such as increasing the range of motion and performance in daily activities, making it a promising rehabilitation tool for women undergoing breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Promising Tool Supporting Oncological Treatment in Breast Cancer. Zasadzka, E., Pieczyńska, A., Trzmiel, T., et al.[2021]

Over 90% of the websites of NCI-Designated Cancer Centers did not provide easily identifiable information about cancer rehabilitation services, indicating a significant gap in patient access to this important information.

Only 8% of the websites contained accurate and detailed descriptions of the core rehabilitation services available, suggesting that many patients may be unaware of the support they can receive during their cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Most National Cancer Institute-Designated Cancer Center Websites Do Not Provide Survivors with Information About Cancer Rehabilitation Services. Silver, JK., Raj, VS., Fu, JB., et al.[2019]

Rehabilitation can help cancer survivors maintain physical, cognitive, and psychological functioning, but providers must understand the complex side effects of cancer treatments to ensure safety during interventions.

This review highlights the need for rehabilitation providers to stay informed about the latest cancer treatments and their side effects, as well as to follow safety guidelines to effectively support patients throughout their cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Focused Review of Safety Considerations in Cancer Rehabilitation. Maltser, S., Cristian, A., Silver, JK., et al.[2023]

Inpatient rehabilitation therapy for colorectal cancer patients shows positive changes in physical health and functional status, as well as improvements in quality of life, although these benefits may decrease over time.

The evidence is limited due to small sample sizes and a lack of comparison groups in most studies, highlighting the need for larger randomized controlled trials to better assess the effectiveness of rehabilitation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in health-related outcomes among colorectal cancer patients undergoing inpatient rehabilitation therapy: a systematic review of observational and interventional studies. Scherer, S., Jansen, L., Boakye, D., et al.[2021]

Current rehabilitation efforts in oncology are heavily focused on inpatient services, with insufficient attention given to outpatient and psychosocial rehabilitation, which are crucial for helping patients cope with cancer-related disabilities.

Initial findings from a pilot study indicate a need for more comprehensive research on vocational rehabilitation and the acceptance of medical rehabilitation services, highlighting the importance of improving the overall rehabilitation care system for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer rehabilitation in the Federal Republic of Germany--a critical review from the perspective of rehabilitation psychology]. Koch, U., Weis, J.[2006]

In a study of 56 women with breast cancer, those undergoing outpatient rehabilitation showed greater improvements in upper limb function and quality of life compared to those in a telerehabilitation program after 8 weeks.

While telerehabilitation is a valid option for postoperative care, face-to-face rehabilitation was found to be more effective in providing personalized treatment, particularly in enhancing physical function and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telerehabilitation and Outpatient Rehabilitation in Women with Breast Cancer. Scaturro, D., Vitagliani, F., Mangano, MS., et al.[2023]

The acute inpatient cancer rehabilitation unit at MD Anderson Cancer Center successfully treated 427 patients over a year, with a mean length of stay of 11 days, demonstrating its capacity to cater to a diverse range of cancer types.

A significant 76% of patients were discharged home after rehabilitation, indicating the effectiveness of the program in improving patient outcomes and facilitating their return to daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient cancer rehabilitation: the experience of a national comprehensive cancer center. Shin, KY., Guo, Y., Konzen, B., et al.[2016]

References

1. India pubmed.ncbi.nlm.nih.gov

How to implement routine electronic patient-reported outcome monitoring in oncology rehabilitation. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patients' outcome expectations and their fulfilment in multidisciplinary stroke rehabilitation. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

CaRE @ Home: Pilot Study of an Online Multidimensional Cancer Rehabilitation and Exercise Program for Cancer Survivors. [2020]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[An experience with the rehabilitation of breast cancer patients after radical treatment]. [2006]

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

Cancer Rehabilitation Providers and Oncology Patient Expectations for Functional Outcomes after Inpatient Rehabilitation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality-based interventions for patients with breast cancer symptom and rehabilitation management: a systematic review and meta-analysis. [2022]

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

Patient safety in cancer rehabilitation. [2012]

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

Virtual Reality as a Promising Tool Supporting Oncological Treatment in Breast Cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Most National Cancer Institute-Designated Cancer Center Websites Do Not Provide Survivors with Information About Cancer Rehabilitation Services. [2019]

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

A Focused Review of Safety Considerations in Cancer Rehabilitation. [2023]

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

Changes in health-related outcomes among colorectal cancer patients undergoing inpatient rehabilitation therapy: a systematic review of observational and interventional studies. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Cancer rehabilitation in the Federal Republic of Germany--a critical review from the perspective of rehabilitation psychology]. [2006]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Telerehabilitation and Outpatient Rehabilitation in Women with Breast Cancer. [2023]

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

Inpatient cancer rehabilitation: the experience of a national comprehensive cancer center. [2016]