NCT03599843

Brief Summary

Cancer continues to have the dubious honor of being the leading cause of premature mortality in Canada. The good news is, advances in early detection and cancer treatments are extending the lives of those diagnosed with the disease. However, as more people are living longer, the impact of the therapies used to treat the disease are becoming increasingly apparent. Ranging from the physiological to psychological, cancer survivors are often confronted with substantial, disabling, and life-threatening consequences. The benefits of physical activity (all movement) and exercise more specifically have long been established as a means of prevention and treatment of chronic disease. Several recent reviews and meta-analyses have demonstrated that exercise is a safe and effective means of preventing and improving a multitude of physical and psychological treatment and disease-related sequelae across the cancer trajectory. For example, we know that cancer survivors who exercise not only have a reduced risk of disease recurrence and cancer mortality, but also have reduced acute/late effects of their cancer and/or its treatment such as anxiety, depression, and cancer-related pain. Regrettably, despite our substantial knowledge base, the majority of cancer survivors are not sufficiently active to realize these benefits over the long-term. Moreover, even with the development of evidence-based guidelines, exercise has not yet been widely implemented as a standard of care in the oncology setting largely due to a lack of resources, exercise expertise, and awareness of benefits. Continuing to provide cancer care with little guidance and understanding of the benefits of exercise places cancer survivors at an increased risk for recurrence, late effects, and/or onset of additional co-morbidities, and premature mortality. Therefore, it is important to consider best practices that will optimize and improve quality of survival. Building on the ongoing work of our Alberta-based colleagues and the Alberta Cancer Exercise (ACE) Program (an evidence-based clinic-to-community cancer exercise model), Activating Cancer Communities through an Exercise Strategy for Survivors (ACCESS) is designed to bridge the gap between research and practice and in doing so, lessen the impact of a cancer diagnosis and its treatment(s) on the physical and psychological well-being of cancer survivors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

7.3 years

First QC Date

July 3, 2018

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (14)

  • Physiological Outcome - resting heart rate

    Seated resting heart rate will be measured in beats per minute.

    12 weeks

  • Physiological outcome - blood pressure

    Seated systolic and diastolic blood pressure will be measured in mm of Hg

    12 weeks

  • Physiological outcome - 6 minute walk test (6MWT)

    The total distance walked in 6 minutes will be measured in meters

    12 weeks

  • Physiological Outcome - handgrip

    Handgrip will be measured in both the left and right hand. Two trials will be conducted on each side and the highest score will be used. Handgrip is measured in kg.

    12 weeks

  • Physiological outcome - timed sit-to-stand

    Time, is seconds, required to move from a seated to a standing position will be recorded.

    12 weeks

  • Physiological Outcome - one legged stance/balance

    Participants will be asked to stand on one leg with no support for as long as they can up to a maximum of 45 seconds. Trials will be conducted on the right and left side and time will be recorded in seconds.

    12 weeks

  • Physiological Outcome - sit-and-reach

    Hamstring flexibility will be measured in centimeters.

    12 weeks

  • Physiological Outcome - shoulder flexibility

    Shoulder flexibility will be measured in degrees

    12 weeks

  • Daily steps

    Total number of daily steps will be recorded using a pedometer.

    12 weeks

  • Functional Assessment of Cancer therapy General (FACT-G)

    The FACT-G is used to assess quality of life. It is a 27 item compilation of questions dived in four primary quality of life domains: 1) physical well-being; 2) social/family well-being; 3) emotional well-being; and 4) functional well-being.

    12 weeks

  • Physical Activity Behaviour

    The Godin Leisure Time Exercise Questionnaire will be used to assess physical activity and sedentary behaviour.

    12 weeks

  • Sleep Quality

    Sleep quality will be assessed using the Pittsburgh sleep quality index.

    12 weeks

  • Depression Anxiety Stress Scales (DASS)

    The depression anxiety stress scales consists of a list of 42 symptoms associated with depression, anxiety or stress. The participant is asked score the severity of the symptom over the past week on a 4 point scale.

    12 weeks

  • Fatigue

    The functional assessment of chronic illness therapy-fatigue (FACIT-F), which is a 13-item scale, will be used to assess participant levels of fatigue.

    12-weeks

Study Arms (1)

ACCESS

EXPERIMENTAL

Individuals that consent to the study will be assigned to a 12-week exercise program (ACCESS)

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Participants will complete a 12 week exercise session that will be comprised of aerobic and/or resistance and/or flexibility training.

ACCESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of cancer;
  • Be 18+ years;
  • Be pre-treatment, receiving active treatment, or have received cancer treatment within the past 5 years or have a late presenting/ongoing side-effects related to the cancer diagnosis;
  • Be able to participate in mild levels of physical activity (at a minimum);
  • Be willing to attend a 12-week exercise program in Halifax;
  • Be able to provide informed written consent in English.

You may not qualify if:

  • \- Less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre (Dickson Bldg)

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Scott A Grandy, PhD

CONTACT

Melanie R Keats, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Type 2, hybrid implementation-effectiveness study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 26, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations