Level of Physical Activity and Its Associations With Fati... | NCT02078518

Studies
Level of Physical Activity and Its Associations With Fatigue and Quality of Life in Multiple Myeloma Survivors

NCT02078518

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

Mar 5, 2014Estimated

Enrollment

75Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Questionnaires

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Not provided

First Submitted Date

Dec 9, 2013

First Submission Date that Met QC Criteria

Mar 3, 2014

First Posted Date

Mar 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haematology-Oncology, Chng Wee Joo, National University Hospital, SingaporePrincipal Investigator

Lead Sponsor

National University Hospital, SingaporeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple Myeloma		Questionnaires will be given to patients for completion.	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other		Multiple Myeloma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Multiple Myeloma
Able to complete questionnaires

Exclusion Criteria:

- Unable to complete questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Multiple Myeloma patients treated in National University Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wee Joo Chng, MB ChB, PhD, FRCP	Contact	(65) 6779 5555		wee_joo_chng@nuhs.edu.sg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore		119074	Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15322968	Background	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.
21522061	Background	Coleman 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.

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms