Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Feasibility of physical activity program as measured by attrition rate.
Study Overview
Brief Summary
Although physical activity (PA) is commonly used to manage symptoms and enhance quality of life (QOL) in cancer survivors, relatively little is known regarding the benefits in advanced multiple myeloma (MM). The primary aims of the Physical Activity in Advanced Cancer Treatment (PAACT) intervention were to examine (1) program feasibility and (2) potential impact on patient outcomes. It is hypothesized that an exercise intervention will be feasible and potentially impactful.
Detailed Description
While the introduction of novel and more effective treatments has seen improved survival in multiple myeloma (MM), the aggressive nature of the disease and these corresponding agents can have a debilitating impact on quality of life (QOL). Exercise can help manage symptoms and enhance QOL in cancer survivors, however relatively little is known regarding the feasibility or benefits of exercise in MM. The purpose of this study was to examine the feasibility of a group- and home-based exercise intervention for individuals with advanced MM. In this single arm study, advanced MM patients (DS stage II-III) participated in a 12-week aerobic and resistance training intervention, with the option of palliative care consultation. Participants attended once weekly supervised group exercise classes and received individually tailored home exercise booklets. Validated measures of physical functioning and patient-reported outcomes, including QOL, fatigue, anxiety, depression, and self-compassion were obtained at baseline and 12-weeks (post-intervention). Optional semi-structured interviews were conducted halfway (week 6) and at the end of the intervention (week 12)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with advanced (Durie-Salmon stage II-III) multiple myeloma
- •18 years of age or older and given a survival prognosis greater than 6 months
- •stable hemoglobin level of ≥80g/L as measured within 2 weeks of enrollment
- •no active infections at the time of enrollment.
Exclusion Criteria
- •refusal of informed consent
- •geographically inaccessible
- •non-English speaking
- •co-morbidities that interfere with participation (i.e., severe mobility issues or cognitive impairments)
- •known or active history of substance abuse
Arms & Interventions
Exercise group
Single-arm study. Participants enrolled engaged in a 12-week exercise program.
Intervention: Physical Activity for Advanced Cancer Treatment (PAACT) (Behavioral)
Outcomes
Primary Outcomes
Feasibility of physical activity program as measured by attrition rate.
Time Frame: 12-weeks
Attrition is defined as the number of participants who dropped out of the program after completing the baseline assessment.
Feasibility of physical activity program as measured by participant recruitment rate.
Time Frame: 3 months
Recruitment as defined by the proportion of patients who participate in the study, out of the total number of eligible patients.
Feasibility of physical activity program as measured by safety (as measured by incidence of patient reported adverse events).
Time Frame: 12-weeks
Safety is described as any adverse event reported by the participants during the 12-week program or fitness assessments, related to program participation.
Feasibility of physical activity program as measured by attendance of group exercise classes.
Time Frame: 12-weeks
Attendance is defined by the number of weekly group-exercise classes attended.
Secondary Outcomes
- Change from Baseline Upper Body Muscular Strength (in kilograms) as measured by a grip strength test using a hand dynamometer at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Upper Body Flexibility (in centimeters) as measured by the Back-Scratch Flexibility test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Aerobic Capacity (in meters) as measured by the six-minute walk test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Functional lower body strength (in number of repetitions) as measured by the Chair stand test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Changes from Baseline Anxiety as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Lower Body Flexibility (in centimeters) as measured by the Chair Sit and Reach flexibility test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Mobility (in seconds) as measured by the 8-foot Timed Up and Go test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Balance (in seconds) as measured by a one-foot balance test at 12 weeks.(Baseline (week 0) and 12 weeks)
- Changes from Baseline Self-compassion as measured by the Self-Compassion Scale (SCS) at 12-weeks.(Baseline (week 0) and 12 weeks)
- Changes from Baseline Physical Activity Levels as measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ) at 12 weeks.(Baseline (week 0) and 12 weeks)
- Change from Baseline Quality of Life as measured by the The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire at 12 weeks.(Baseline (week 0) and 12 weeks)
- Changes from Baseline Depression as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.(Baseline (week 0) and 12 weeks)
Investigators
Dr. Nicole Culos-Reed
Principal Investigator
University of Calgary