Clinical trial NCT04303091: The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
Official title: Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Hematologic Neoplasms
Advanced Cancer
Keywords: Physical activity
Exercise
Hematology
Intervention
Supportive cancer care
Multiple myeloma
Resistance training
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group feasibility study
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of physical activity program as measured by participant recruitment rate.
timeFrame: 3 months
measure: Feasibility of physical activity program as measured by attendance of group exercise classes.
timeFrame: 12-weeks
measure: Feasibility of physical activity program as measured by attrition rate.
timeFrame: 12-weeks
measure: Feasibility of physical activity program as measured by safety (as measured by incidence of patient reported adverse events).
timeFrame: 12-weeks
Secondary outcomes:
measure: Change from Baseline Upper Body Muscular Strength (in kilograms) as measured by a grip strength test using a hand dynamometer at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Functional lower body strength (in number of repetitions) as measured by the Chair stand test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Lower Body Flexibility (in centimeters) as measured by the Chair Sit and Reach flexibility test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Upper Body Flexibility (in centimeters) as measured by the Back-Scratch Flexibility test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Mobility (in seconds) as measured by the 8-foot Timed Up and Go test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Balance (in seconds) as measured by a one-foot balance test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Aerobic Capacity (in meters) as measured by the six-minute walk test at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Quality of Life as measured by the The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Change from Baseline Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Changes from Baseline Anxiety as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Changes from Baseline Depression as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Changes from Baseline Self-compassion as measured by the Self-Compassion Scale (SCS) at 12-weeks.
timeFrame: Baseline (week 0) and 12 weeks
measure: Changes from Baseline Physical Activity Levels as measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ) at 12 weeks.
timeFrame: Baseline (week 0) and 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Nicole r Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: