Virtual Rehabilitation for Cancer Survivors

Overseen By Jennifer Jones, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Neurological disease, Major depressive disorder, others

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: 4

Duration: 8 weeks

388 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on certain ongoing therapies like trastuzumab, immunotherapy, and others, so it seems likely you can continue your current medications.

Is virtual rehabilitation safe for cancer survivors?

The studies suggest that virtual rehabilitation, including telehealth and hybrid delivery methods, is generally safe for cancer survivors, as no significant safety concerns were reported in the research. ^{1 2 3 4 5}

How is the CaRE@Home treatment different from other cancer rehabilitation treatments?

CaRE@Home is unique because it offers a virtual, online rehabilitation and exercise program for cancer survivors, making it accessible to those who cannot attend facility-based programs due to distance, cost, or other commitments. This telehealth approach allows for scalable and remote interventions, potentially reaching a larger population of cancer survivors. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment CaRE@Home intervention for cancer survivors?

Research suggests that telehealth-based cancer rehabilitation, like CaRE@Home, can effectively improve physical and mental health in cancer survivors, similar to traditional in-clinic programs. Studies show that hybrid and telehealth delivery modes can provide comparable benefits in health outcomes and patient satisfaction, making them a promising option for increasing access to rehabilitation services. ^{1 4 5 6 9}

Who Is on the Research Team?

Jennifer Jones, PhD

Principal Investigator

UHN Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

This trial is for cancer survivors aged 18+ who've finished primary treatment within the last 2 years. It's open to those with breast, colorectal, head and neck cancers or lymphoma if they're responding well to ongoing therapies like immunotherapy. Participants need good enough English for the intervention, internet access, and a WHO-DAS score over 5 indicating a need for rehab.

Inclusion Criteria

I need help because my daily activities are affected by my cancer.

I am still on maintenance therapy after my main cancer treatment and have responded well to it.

Communicate sufficiently in English to complete intervention and questionnaires

Exclusion Criteria

My health condition prevents me from participating in rehabilitation.

You have health conditions or injuries that make it unsuitable for you to do exercises that involve moving over long distances.

I have been diagnosed with major depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo an 8-week virtual cancer rehabilitation program (CaRE@Home) with weekly e-modules, exercise prescriptions, and counseling

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3 and 6 months post-intervention

6 months

2 visits (in-person) at 3 and 6 months

Maintenance Assessment

Additional follow-up at 6 months post-intervention to assess maintenance of treatment gains

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CaRE@Home intervention

Trial Overview The CaRE@Home program is being tested in this study. It's an 8-week virtual rehabilitation designed to help cancer survivors manage impairments related to their condition. The effectiveness of this online program on disability levels and other aspects like anxiety and quality of life will be measured across several Canadian centers.

How Is the Trial Designed?

Group I: CaRE@Home intervention Experimental Treatment 1 Intervention

Group II: Usual Care group Active Control 1 Intervention

CaRE@Home intervention is already approved in Canada for the following indications:

Approved in Canada as CaRE@Home for:

• Rehabilitation for cancer survivors with identified cancer-related impairments

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Telehealth-based cancer rehabilitation interventions, primarily delivered via telephone and lasting an average of 16.5 weeks, show potential for improving disability in adult cancer survivors, although the effects are generally small.

The review of 68 studies highlights the need for standardized measures of disability, as the variability in outcomes makes it difficult to draw strong conclusions about the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of telehealth-based cancer rehabilitation interventions on disability: a systematic review. Brick, R., Padgett, L., Jones, J., et al.[2023]

The ReStOre@Home telehealth rehabilitation program for cancer survivors was feasible, with a 32.4% recruitment rate and a 75% retention rate among 12 participants, indicating strong adherence and satisfaction with the program.

Participants reported significant improvements in physical and psychological wellbeing, although some preferred in-person interactions, suggesting that future programs could benefit from a hybrid approach that combines online and face-to-face support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Delivery of a Multi-Disciplinary Rehabilitation Programme for Upper Gastro-Intestinal Cancer: ReStOre@Home Feasibility Study. Brennan, L., Sadeghi, F., O'Neill, L., et al.[2022]

A study involving 2,611 cancer survivors found that hybrid rehabilitation delivery (combining in-clinic and telehealth visits) resulted in similar improvements in health-related quality of life measures compared to traditional in-clinic-only rehabilitation.

Both delivery methods showed comparable patient experiences and outcomes, suggesting that hybrid rehabilitation could be an effective alternative to increase access to care for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Clinic versus Hybrid Cancer Rehabilitation Service Delivery during the COVID-19 Pandemic: An Outcome Comparison Study. Wood, KC., Giri, S., Kendig, TD., et al.[2023]

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]

This study outlines a feasibility protocol for a Web-based portal designed to monitor physical activity and sleep in cancer patients, aiming to increase their physical activity levels over a 10-week period with three different intervention groups.

The study will assess the effectiveness of adding personalized messaging and coaching to standard activity monitoring, which could enhance patient engagement and support behavior change in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study. Marthick, M., Dhillon, HM., Alison, JA., et al.[2020]

In a study of 257 cancer patients discharged from acute inpatient rehabilitation, 21% were readmitted to the hospital within 30 days, indicating a higher readmission rate compared to other rehabilitation populations.

Key risk factors for readmission included lower locomotion scores, a higher number of medications, and lower hemoglobin levels at discharge, suggesting that these factors could help identify patients at greater risk for complications after leaving the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirty-day hospital readmission rate, reasons, and risk factors after acute inpatient cancer rehabilitation. Tennison, JM., Rianon, NJ., Manzano, JG., et al.[2022]

This study will evaluate the effectiveness of a real-time interactive digital healthcare system compared to a traditional brochure-based rehabilitation program for improving shoulder range of motion (ROM) in 100 post-operative breast cancer patients over 12 weeks.

The primary focus is on measuring changes in shoulder ROM, while secondary outcomes will assess pain, functional abilities, and quality of life, providing a comprehensive view of rehabilitation effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial. Park, HY., Nam, KE., Lim, JY., et al.[2022]

Breast cancer survivors experience unmet needs for support and information during home rehabilitation after surgery, highlighting the potential for mobile health (mHealth) systems to provide necessary assistance.

Participants expressed a desire for a reliable mHealth tool that offers exercise support, as current options are lacking and often not tailored to their specific rehabilitation needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study. Brennan, L., Kessie, T., Caulfield, B.[2021]

A scoping review of 24 articles highlighted the need for virtual care models in cancer survivorship to enhance sustainable care and improve patient outcomes, particularly for breast and prostate cancer survivors.

The review identified effective technologies used in virtual care, such as web platforms and mobile applications, and emphasized the importance of integrating these models with existing health systems and involving diverse patient communities in their design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual care models for cancer survivorship. Pham, Q., Hearn, J., Gao, B., et al.[2023]

Citations

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

The influence of telehealth-based cancer rehabilitation interventions on disability: a systematic review. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Telehealth Delivery of a Multi-Disciplinary Rehabilitation Programme for Upper Gastro-Intestinal Cancer: ReStOre@Home Feasibility Study. [2022]

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

In-Clinic versus Hybrid Cancer Rehabilitation Service Delivery during the COVID-19 Pandemic: An Outcome Comparison Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Canada pubmed.ncbi.nlm.nih.gov

Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study. [2020]

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

Thirty-day hospital readmission rate, reasons, and risk factors after acute inpatient cancer rehabilitation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial. [2022]

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

Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study. [2021]

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

Virtual care models for cancer survivorship. [2023]