Trial Information

A Pilot Study to Explore the Role of Physical Activity as a Quality of Life Intervention in Advanced Cancer Patients

Background Information Cancer is one of the leading causes of mortality and morbidity
worldwide[1]. The resultant morbidities of cancer and its treatment are manifold; common
physiologic symptoms include pain, muscle weakness and fatigue, whereas common psychological
symptoms include depression, anxiety and poor sense of well-being. As methods of cancer
detection and treatment improve, survival is prolonged and the lifetime burden of these
adverse effects increases[2]. Addressing these issues is critical towards maximizing quality
of life, a multidimensional construct encompassing all physical and psychosocial factors[3].

Physical activity is one potential strategy for ameliorating quality of life in all phases
of cancer and its treatment [4]. Increasing evidence indicates a role for physical activity
in improving several aspects of physical and psychological well-being that may contribute to
quality of life in cancer patients, including muscle strength, functional capacity, mood and
self-esteem[5]. Not only does physical activity have proven benefits in terms of physical
performance and fatigue in cancer survivors, it may improve the capacity for basic
activities of daily living such that functional independence can be maintained as long as
possible[6]. Although this has been demonstrated for early stage cancer survivors, there is
limited evidence for the use of physical activity in the palliation of patients with
actively progressive, advanced incurable cancer[7]. A few studies of exercise in advanced
metastatic cancer patients have demonstrated benefits in quality of life outcomes, however
small sample sizes have limited their generalizability to the larger end-stage cancer
population[8-12]. There exists a critical need to more specifically identify exercise
programmes targeted to advanced cancer patients' needs, interests and preferences[13].

Purpose The purpose of this pilot study is to explore the physical activity preferences and
interests of actively progressive, advanced incurable cancer patients and to determine if
there is any association between physical activity and quality of life in this population.
The ultimate aim of this study is to provide preliminary data on which a subsequent
intervention trial can be based if encouraging results are obtained.

Objectives

1. To describe advanced cancer patient's attitudes towards physical activity,
self-efficacy for physical activity and programming preferences.

2. To examine the relationship between quality of life, medical and demographic variables,
and physical activity in advanced cancer patients.

3. To identify which advanced cancer populations would be willing and able to participate
in a physical activity intervention.

Study Design This pilot study will be cross-sectional in design, using a survey
questionnaire combining both closed and open-ended questions. After written consent is
obtained, the investigator will administer the survey questionnaire via face-to-face
interview with the patient at a time and location that is mutually convenient for both
parties. The survey questionnaire will be a one-time assessment, with anticipated duration
of 45 minutes for completion. The survey questionnaire will be developed based on
combination of validated physical activity and quality of life questionnaires, including the
McGill Quality of Life Questionnaire[14], the Edmonton Symptom Assessment Scale[15], and the
Late-Life Function and Disability Instrument[16]. Exercise program preferences and Theory of
Planned Behavior constructs will be assessed using items taken from previous research
assessing physical activity in cancer survivors[17-19]. Medical and demographic information
will be collected using self-report measures and via medical chart review. Date of death
will be determined from the cancer registry.

Inclusion Criteria

1. 18 years of age or older

2. Be able to understand, provide written informed consent in, and speak English

3. Cognitive ability to participate (defined as a normal Folstein's Mini Mental Status
Score for patient's age and education level[20])

4. Diagnosis of advanced cancer (defined as progressive, incurable, locally recurrent or
metastatic disease)

5. Approval of treating physician Exclusion Criteria

1. Any absolute contraindications to exercise (including acute MI within 2 days,
symptomatic/severe aortic stenosis, decompensated heart failure, symptomatic/hemodynamically
significant cardiac arrhythmias, unstable angina not previously stabilized by medical
therapy, acute aortic dissection, acute myocarditis/pericarditis, acute pulmonary
embolus/infarction) 2. Palliative Performance Status level of 30% or less[21] 3. Any patient
who, in the opinion of the treating physician, is within the last days to hours of life
Recruitment Patients diagnosed with advanced cancer (defined as progressive, incurable,
locally recurrent or metastatic disease) will be recruited from the Cross Cancer Institute
and the Capital Health Regional Palliative Home Care Program. Eligible patients will be
identified by case managers in the Capital Health Regional Palliative Home Care Program, and
study information will be included in the ethics-approved Pain and Symptom & Palliative Care
Research Group studies brochure distributed to outpatients at the Cross Cancer Institute by
the research nurse or study coordinator. Patient contact will be made by telephone outside
of the Cross Cancer Institute thereafter. Patients who accept the invitation to participate
will provide written consent prior to commencing the study.

Statistical Analysis To detect a change of 0.5 standard deviations (a medium effect size) in
the various outcomes (quality of life, physical activity) with a power of 80% and a
two-tailed alpha value of <0.05, we need 29 participants. Based on previous study sampling
of the Cross Cancer Institute and Capital Health Regional Palliative Home Care by the Pain &
Symptom and Palliative Care Research Group, 30 patients could be expected to be recruited
over a nine month period given frailty and end-of-life symptom limitations. The study will
commence with the enrollment of the first subject, subsequent subjects will be recruited on
an ongoing basis. Initial analysis will provide complete descriptive information on the
demographic and medical profile of the study participants. Primary analysis will use
multiple regression to explore the relationship between demographic/medical characteristics,
physical function and quality of life variables.

Data Safety Monitoring Committee Ethical and scientific approval will be obtained from the
local Institutional Review Boards affiliated with the Cross Cancer Institute and Capital
Health Regional Palliative Home Care prior to study commencement. All serious adverse events
will be reported to the local IRBs as well as each participant's treating physician. The
project coordinator, under the supervision of the principal investigator, will be
responsible for reporting any serious adverse events. The local IRBs will oversee the
validity and integrity of data by conducting periodic audits of study records.