Multiple MyelomaNCT02078518
Level of Physical Activity and Its Associations With Fatigue and Quality of Life in Multiple Myeloma Survivors
An observational study of Multiple Myeloma, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize QOL. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Questionnaires
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2013to Aug 2014
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Myeloma patients treated in National University Hospital.
Who may be able to join
- Diagnosis of Multiple Myeloma
- Able to complete questionnaires
Who cannot join
- Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Wee Joo Chng, MB ChB, PhD, FRCP, (65) 6779 5555, wee_joo_chng@nuhs.edu.sg
Wee Joo Chng, MB ChB, PhD, FRCP
About this study
The purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize QOL. A positive correlation may suggest that exercise is such an intervention.
The hypothesis are multiple myeloma survivors are performing low levels of physical activity. Higher levels of physical activity will be associated with higher levels of QOL and lower fatigue levels.
Read the detailed description
Multiple myeloma its associated treatment often result in persistent symptoms such as fatigue, pain, neuropathy and diminished functional performance that can affect the survivor's quality of life (QOL). And as survival for multiple myeloma continues to improve, physical activity may be a supportive therapy that can help to address the multitude of QOL concerns. Physical activity is a modifiable behavior, and has been proposed as an important non-pharmacologic intervention to improve health-related outcomes among cancer survivors. The American College of Sports Medicine examined evidence of the impact of physical activity in cancer survivors, and concluded that physical activity is safe for cancer patients, both during and after cancer treatment, and may lead to improved physical functioning, decreased physical fatigue, and improved QOL in a number of cancer survivor groups, including hematopoietic malignancies. While a small number of studies have suggested that exercise may reap benefits in QOL and fatigue in multiple myeloma survivors, none were conducted in the local context.Given the limited evidence, the primary objectives of this preliminary study is to estimate the prevalence of physical activity among a local sample of multiple myeloma survivors, and to investigate its associations with reported fatigue and quality of life.
- Conditions
- Multiple Myeloma
- Being tested
- Questionnaires
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma | Questionnaires will be given to patients for completion. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haematology-Oncology, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078518
- Sponsor's protocol ID
- 2013/00724
- Status last verified
- Mar 2014
- First submitted
- 9 Dec 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones LW, Courneya KS, Vallance JK, Ladha AB, Mant MJ, Belch AR, Stewart DA, Reiman T. Association between exercise and quality of life in multiple myeloma cancer survivors. Support Care Cancer. 2004 Nov;12(11):780-8. doi: 10.1007/s00520-004-0668-4.
PubMed 15322968Coleman EA, Goodwin JA, Coon SK, Richards K, Enderlin C, Kennedy R, Stewart CB, McNatt P, Lockhart K, Anaissie EJ, Barlogie B. Fatigue, sleep, pain, mood, and performance status in patients with multiple myeloma. Cancer Nurs. 2011 May-Jun;34(3):219-27. doi: 10.1097/NCC.0b013e3181f9904d.
PubMed 21522061
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Physical Activity and Its Associations With Fatigue and Quality of Life in Multiple Myeloma Survivors
- ClinicalTrials.gov ID
- NCT02078518
- Acronym / sponsor ID
- 2013/00724
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- 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.
The purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize QOL. A positive correlation may suggest that exercise is such an intervention.
The hypothesis are multiple myeloma survivors are performing low levels of physical activity. Higher levels of physical activity will be associated with higher levels of QOL and lower fatigue levels.
Detailed description
Multiple myeloma its associated treatment often result in persistent symptoms such as fatigue, pain, neuropathy and diminished functional performance that can affect the survivor's quality of life (QOL). And as survival for multiple myeloma continues to improve, physical activity may be a supportive therapy that can help to address the multitude of QOL concerns. Physical activity is a modifiable behavior, and has been proposed as an important non-pharmacologic intervention to improve health-related outcomes among cancer survivors. The American College of Sports Medicine examined evidence of the impact of physical activity in cancer survivors, and concluded that physical activity is safe for cancer patients, both during and after cancer treatment, and may lead to improved physical functioning, decreased physical fatigue, and improved QOL in a number of cancer survivor groups, including hematopoietic malignancies. While a small number of studies have suggested that exercise may reap benefits in QOL and fatigue in multiple myeloma survivors, none were conducted in the local context.Given the limited evidence, the primary objectives of this preliminary study is to estimate the prevalence of physical activity among a local sample of multiple myeloma survivors, and to investigate its associations with reported fatigue and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma | – | Other: QuestionnairesQuestionnaires will be given to patients for completion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma patients treated in National University Hospital.
Key inclusion criteria (2 listed)
- Diagnosis of Multiple Myeloma
- Able to complete questionnaires
Key exclusion criteria (1 listed)
- Unable to complete questionnaires
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 |
|---|---|---|
| Questionnaires | Other | Multiple Myeloma |
Primary outcome
Change in the level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Background: PubMed 15322968Jones LW, Courneya KS, Vallance JK, Ladha AB, Mant MJ, Belch AR, Stewart DA, Reiman T. Association between exercise and quality of life in multiple myeloma cancer survivors. Support Care Cancer. 2004 Nov;12(11):780-8. doi: 10.1007/s00520-004-0668-4.
- Background: PubMed 21522061Coleman EA, Goodwin JA, Coon SK, Richards K, Enderlin C, Kennedy R, Stewart CB, McNatt P, Lockhart K, Anaissie EJ, Barlogie B. Fatigue, sleep, pain, mood, and performance status in patients with multiple myeloma. Cancer Nurs. 2011 May-Jun;34(3):219-27. doi: 10.1097/NCC.0b013e3181f9904d.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2014. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wee Joo Chng, MB ChB, PhD, FRCP ((65) 6779 5555, wee_joo_chng@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078518, which also lists 2 linked publications.
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 5 Mar 2014.