Multiple MyelomaNCT04303091
The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
A study testing Physical Activity for Advanced Cancer Treatment (PAACT) in people with Multiple Myeloma and Hematologic Neoplasms, run by Dr. Nicole Culos-Reed at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Hematologic Neoplasms, Advanced Cancer
- What is being tested?
- Physical Activity for Advanced Cancer Treatment (PAACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
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.
Read the 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)
- Conditions
- Multiple Myeloma, Hematologic Neoplasms, Advanced Cancer
- Being tested
- Physical Activity for Advanced Cancer Treatment (PAACT)
- Keywords
- Physical activity, Exercise, Hematology, Intervention, Supportive cancer care, Multiple myeloma, Resistance training
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity for Advanced Cancer Treatment (PAACT)Behavioural
Also called PAACT
12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Single-arm study. Participants enrolled engaged in a 12-week exercise program. Receives: Behavioral: Physical Activity for Advanced Cancer Treatment (PAACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of physical activity program as measured by participant recruitment rate.
Recruitment as defined by the proportion of patients who participate in the study, out of the total number of eligible patients.
Measured: 3 months
Feasibility of physical activity program as measured by attendance of group exercise classes.
Attendance is defined by the number of weekly group-exercise classes attended.
Measured: 12-weeks
Feasibility of physical activity program as measured by attrition rate.
Attrition is defined as the number of participants who dropped out of the program after completing the baseline assessment.
Measured: 12-weeks
Feasibility of physical activity program as measured by safety (as measured by incidence of patient reported adverse events).
Safety is described as any adverse event reported by the participants during the 12-week program or fitness assessments, related to program participation.
Measured: 12-weeks
Secondary outcomes (13)
Change from Baseline Upper Body Muscular Strength (in kilograms) as measured by a grip strength test using a hand dynamometer at 12 weeks.
Total grip strength in kilograms is recorded as the sum from the best score of two trials recorded for each hand. Differences between baseline and post-intervention assessments are evaluated.
Measured: 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.
Chair stand test records the number of times a participant can stand from a seated position in 30 seconds. Differences between baseline and post-intervention assessments are evaluated.
Measured: 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.
In the Chair Sit and Reach Flexibility test, lower body flexibility is assessed by having the participant sit on the edge of a seat. The participant extends the leg being tested in front of the hip, with the heel on the floor and the ankle dorsiflexed approximately 90 degrees. The participant flexes the untested leg so that the sole of the foot is flat on the floor about 6 to 12 inches to the side of the body's midline. With the extended leg as straight as possible and the hands on top of each other (palms down), the participant slowly bends forward at the hip joint, keeping the spine as straight as possible and the head in normal alignment (not tucked) with the spine. The participant reaches down the extended leg, trying to touch the toes, and holds this position for 2 sec. A ruler is ran parallel to the participant's lower leg. Two practice trials are allowed followed by two test trials.The best measurement is taken.
Measured: 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.
In the Back-Scratch Flexibility test, upper body flexibility is assessed by asking the participant to reach, with the preferred hand (palm down and fingers extended), over the shoulder and down the back while reaching around and up the middle of the back with the other hand (palm up and fingers extended). The participant is allowed two practice trials followed by two test trials.The best measurement is taken.
Measured: 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.
The 8-foot Timed Up and Go test measures the time to move from a seated position, walk 8 feet, and return to a seated position.The best of two trials is taken.
Measured: Baseline (week 0) and 12 weeks
Change from Baseline Balance (in seconds) as measured by a one-foot balance test at 12 weeks.
Participant's Balance is assessed by measuring the time the participant is able to stand on one-foot. Both feet measured. A 45-second cut-off time is implemented.
Measured: Baseline (week 0) and 12 weeks
Change from Baseline Aerobic Capacity (in meters) as measured by the six-minute walk test at 12 weeks.
In the Six-Minute Walk Test, participants are instructed to walk as far as they can for 6 min around a track. Distances are recorded to the nearest 0.5 m.
Measured: 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.
The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire is comprised of the 27-item FACT-General (FACT-G) scale, which provides information on physical, social, emotional, and functional well-being domains in conjunction with 14 MM-specific supplementary questions. The combined subscales of physical, functional, and MM specific domains contribute to the Trial Outcome Index (TOI) score (range of 0-112). The questionnaire is rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing improved quality of life.
Measured: 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.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire is a13-item questionnaire rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing decreased fatigue.
Measured: Baseline (week 0) and 12 weeks
Changes from Baseline Anxiety as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale. Subscales for anxiety were calculated with a range of 0-21, with low scores (0-7) representing normal levels.
Measured: Baseline (week 0) and 12 weeks
Changes from Baseline Depression as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale. Subscales for depression were calculated with a range of 0-21, with low scores (0-7) representing normal levels.
Measured: Baseline (week 0) and 12 weeks
Changes from Baseline Self-compassion as measured by the Self-Compassion Scale (SCS) at 12-weeks.
The Self-Compassion Scale (SCS) is a 26-item scale. The following subscales are measured on a 5-point Likert scale (1 = almost never to 5= almost always): self- kindness, self-judgment, common humanity, isolation, mindfulness and over-identified items. In this study a grand mean representing an overall measure of self-compassion willl be calculated, with a higher score representing higher levels of self-compassion.
Measured: 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.
The Godin Leisure Time Exercise Questionnaire (GLTEQ) assesses current physical activity levels. Participants report on the duration and frequency of mild, moderate, and strenuous PA within a typical week over the past month. Total weekly physical activity is calculated.
Measured: Baseline (week 0) and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Mar 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group feasibility study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Nicole Culos-Reed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Nicole Culos-Reed, University of Calgary
- Investigators
- Nicole r Culos-Reed, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303091
- Sponsor's protocol ID
- HREBA.CC-17-0058
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT04303091
- Acronym / sponsor ID
- HREBA.CC-17-0058
- Conditions
- Multiple Myeloma, Hematologic Neoplasms, Advanced Cancer
- Keywords
- Physical activity, Exercise, Hematology, Intervention, Supportive cancer care, Multiple myeloma, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dr. Nicole Culos-ReedUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group feasibility study
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Physical Activity for Advanced Cancer Treatment (PAACT)Single-arm study. Participants enrolled engaged in a 12-week exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity for Advanced Cancer Treatment (PAACT)Also: PAACT12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered. | Behavioural | Exercise group |
Primary outcome
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 attendance of group exercise classes.
Time frame: 12-weeks
Attendance is defined by the number of weekly group-exercise classes attended.
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 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.
13 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (week 0) and 12 weeks
Change from Baseline Balance (in seconds) as measured by a one-foot balance test at 12 weeks.
Time frame: Baseline (week 0) and 12 weeks
Change from Baseline Aerobic Capacity (in meters) as measured by the six-minute walk test at 12 weeks.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (week 0) and 12 weeks
Changes from Baseline Anxiety as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
Time frame: Baseline (week 0) and 12 weeks
Changes from Baseline Depression as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
Time frame: Baseline (week 0) and 12 weeks
Changes from Baseline Self-compassion as measured by the Self-Compassion Scale (SCS) at 12-weeks.
Time frame: 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.
Time frame: Baseline (week 0) and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole r Culos-Reed, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity for Advanced Cancer Treatment (PAACT) in people with Multiple Myeloma and Hematologic Neoplasms, run by Dr. Nicole Culos-Reed at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of physical activity program as measured by participant recruitment rate. (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.