Each site will complete an 18-month Baseline Phase, in which patients and sites are observed during a period of usual care, prior to introducing the C4 Program intervention. In this phase, a sample of newly diagnosed patients will be recruited and enrolled in the Baseline Group, and data will be collected on them via patient surveys and EHR data abstraction over a period of four months for most outcomes, except for overall survival, which will be assessed at 12 months after diagnosis

new sample of newly diagnosed patients (excluding anyone from the Baseline Phase) will be recruited and enrolled in the Implementation Group, and the same data will be collected on them that was collected in the Baseline Group, at the same time points

C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

C4 Program

Yvonne Taul, RN

Timothy Mullett, MD

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life.

1 year survival after diagnosis (12 months)

Merck Sharp & Dohme LLC

Timothy Mullett

Professor

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Prostatic Neoplasms

Head and Neck Neoplasms

Quality of Life

Anti-Infective Agents

All Drugs and Chemicals

Dermatologic Agents

Chlorhexidine

Chlorhexidine gluconate

All participants will be involved in group exercise classes, twice a week for 12 weeks.

The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.

Group Exercise Classes

Nicole Culos-Reed, PhD

Julianna Dreger, M.ClinExPhys

Margaret L McNeely, PhD

Melanie Keats, PhD

Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.

As cancer survivorship numbers grow, a focus on positive health in survivorship is essential. Exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (CS). However, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" CS.

In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise Oncology Survivorship (EOS) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural Canadian communities.

Investigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. These fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. If, due to COVID-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.

Hybrid implementation effectiveness study

EXCEL: Exercise for Cancer to Enhance Living Well

Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life

No plan at this time to share IPD outside of the research team.

Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.

Change in 6-minute walk test (m) or 2 minute step test (steps) results

Change in sit-to-stand (number of repetitions in 30 seconds)

Change in active shoulder flexion range of motion (degrees)

Change in one legged stance test (seconds)

Change in fatigue, mood, and QOL, recorded via m-Health app

Change in Edmonton Symptom Assessment Scale.

- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.

Change in Godin Leisure Time Exercise Questionnaire

Change in EuroQual - 5Dimensions (EQ-5D) tool

- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.

Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale

- scale is from 0-4, where 0 means "not at all" and 4 means "very much".

Change in Functional Assessment of Cancer Therapy - General subscale

- scale is from 0-4, where 0 means "not at all" and 4 means "very much".

Change in Functional Assessment of Cancer Therapy - Cognitive subscale

- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Connected Cancer Care (C4): Intervention Evaluation	NCT06326567	Cancer Health Care Uti...	C4 Program	18 Years -	University of Kentucky
Comprehensive Connected Cancer Care (C4): Intervention Evaluation	NCT06326567	Cancer Health Care Uti...	C4 Program	18 Years -	University of Kentucky
EXCEL: Exercise for Cancer to Enhance Living Well	NCT04478851	Cancer Head and Neck C... Colon Cancer Breast Cancer Prostate Cancer Cancer Caregive...	Group Exercise ...	18 Years - 100 Years	University of Calgary

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