AzTrials
AzTrials

Haematological MalignancyNCT04236063

Rehabilitation Needs of the Malaysian Haematological Cancer Survivors

An observational study of Haematological Malignancy and Leukemia, Acute, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Many cancers are being treated more effectively nowadays due to the raised awareness and early detection as well as advancement in researches and technology. Despite the rising number of cancer survivors in the coming years, these survivors are still plagued by the poor quality of life due to physical and… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
WHODAS 2.0 Questionnaire
How many people
168 participants
Where
1 siteMalaysia
Study dates
15 Jul 2019to 31 May 2020
How long will I take part?
1 Day
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patient diagnosed with haematological malignancy under follow up at UMMC Haemato-oncology clinic

Who may be able to join

  • patient with haematological malignancy
  • agreeable to participate in the interview

Who cannot join

  • ill at the time of follow up
  • unable to understand English, Malay or Chinese
  • refuse to be interviewed

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University Malaya

    Kuala Lumpur, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

Official title: Rehabilitation Needs of the Malaysian Haematological Cancer Survivors Through a Single Centre Experience

Many cancers are being treated more effectively nowadays due to the raised awareness and early detection as well as advancement in researches and technology. Despite the rising number of cancer survivors in the coming years, these survivors are still plagued by the poor quality of life due to physical and psychological impairment. According to the National Cancer Registry Report from 2007-2011, haematological cancer is one of the ten most common cancers in Malaysian population. Many haematological cancer survivors in Malaysia are reportedly having poor quality of life due to multiple physical and emotional impairments which leads to further disability in life. It is thus an important effort to identify the rehabilitation needs in these cancer survivors to implement alternatives to improve the disease outcome through cancer rehabilitation.

Read the detailed description

A cross-sectional questionnaire-based study will be employed to identify the rehabilitation needs and predictors of needs in outpatient hemato-oncological cohort at UMMC Hemato-oncology Clinic for 12 months. The validated questionnaire employed evaluates the potential disabilities that could affect the aforementioned patients in domains such as communication, independence in mobility, self-care, social participation, handling relationships and domestic activity of daily living a month prior to the survey.

Participants of age between 18 to 80 years old, diagnosed with haemato-oncological illnesses will be screened; excluding potential participants who are too ill or cannot understand English, Malay, or Chinese; to be recruited in the research.

Based on the findings from the analysis, rehabilitation needs could be tailored accordingly to improve quality of life of these patients

Being tested
WHODAS 2.0 Questionnaire
Keywords
Cross sectional study
Medical subject headings
Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WHODAS 2.0 QuestionnaireOther

    36-item WHODAS 2.0 questionnaire will be used for each patient to identify difficulty faced by patient over past 30 days from the day of interview

Study groups in NCT04236063
Study groupRoleWhat they receive
Haematological malignancyPatients with haematological malignancy
Receives: Other: WHODAS 2.0 Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. World Health Organization Disability Assessment Schedule (WHODAS) 2.0

    WHODAS 2.0 is a practical, generic assessment tool that measures health and disability at population level or in clinical practice. It identifies possible disabilities in 6 domains of life namely Cognitive, Mobility, Self Care, Relationship, Life Activities and Participation. In view of its resemblance to the International Classification of Functioning, Disability and Health (ICF) model, direct identification of functioning and disability separately from the disease condition could be done.

    Each domain has few sets of questions pertaining to the activities; the responses and scores of each question are divided into none (0), mild (1), moderate (2), severe (3) and extremely cannot do (4). The scores from each domain will be summed and higher scores signifies higher disability status.

    Measured: 30 days ago from interview date

Secondary outcomes (1)

  1. Identifying patients who are at risk of disability from haemato-oncological illness

    Disability outcomes of different groups of patients (of demographics and diagnosis) were analyzed using SPSS program and identification of patients who were vulnerable to haematological cancers were done using ANOVA test.

    Measured: 30 days ago from interview date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start15 Jul 2019
  3. Primary completion31 Mar 2020
  4. Study completion31 May 2020

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
168 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236063
Sponsor's protocol ID
201945-7310
Status last verified
Nov 2020
First submitted
23 Sep 2019
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Okamura H. Importance of rehabilitation in cancer treatment and palliative medicine. Jpn J Clin Oncol. 2011 Jun;41(6):733-8. doi: 10.1093/jjco/hyr061.

    PubMed 21622762

  • Allart-Vorelli P, Porro B, Baguet F, Michel A, Cousson-Gelie F. Haematological cancer and quality of life: a systematic literature review. Blood Cancer J. 2015 Apr 24;5(4):e305. doi: 10.1038/bcj.2015.29.

    PubMed 25909835

  • Priscilla D, Hamidin A, Azhar MZ, Noorjan KO, Salmiah MS, Bahariah K. Quality of life among patients with hematological cancer in a Malaysian hospital. Med J Malaysia. 2011 Jun;66(2):117-20.

    PubMed 22106690

  • Hansen DG, Larsen PV, Holm LV, Rottmann N, Bergholdt SH, Sondergaard J. Association between unmet needs and quality of life of cancer patients: a population-based study. Acta Oncol. 2013 Feb;52(2):391-9. doi: 10.3109/0284186X.2012.742204. Epub 2012 Dec 17.

    PubMed 23244672

  • Dietz JH Jr. Rehabilitation of the cancer patient. Med Clin North Am. 1969 May;53(3):607-24. No abstract available.

    PubMed 4305950

  • Banks E, Byles JE, Gibson RE, Rodgers B, Latz IK, Robinson IA, Williamson AB, Jorm LR. Is psychological distress in people living with cancer related to the fact of diagnosis, current treatment or level of disability? Findings from a large Australian study. Med J Aust. 2010 Sep 6;193(S5):S62-7. doi: 10.5694/j.1326-5377.2010.tb03931.x.

    PubMed 21542449

  • Kim YM, Kim DY, Chun MH, Jeon JY, Yun GJ, Lee MS. Cancer rehabilitation: experience, symptoms, and needs. J Korean Med Sci. 2011 May;26(5):619-24. doi: 10.3346/jkms.2011.26.5.619. Epub 2011 Apr 21.

    PubMed 21532851

  • Spill GR, Hlubocky FJ, Daugherty CK. Oncologists' and physiatrists' attitudes regarding rehabilitation for patients with advanced cancer. PM R. 2012 Feb;4(2):96-108. doi: 10.1016/j.pmrj.2011.08.539.

    PubMed 22373458

  • Handberg C, Jensen CM, Maribo T. Lack of Needs Assessment in Cancer Survivorship Care and Rehabilitation in Hospitals and Primary Care Settings. J Clin Med Res. 2017 Oct;9(10):864-871. doi: 10.14740/jocmr3160w. Epub 2017 Sep 1.

    PubMed 28912923

Questions about this trial

What is this clinical trial studying?

An observational study of Haematological Malignancy and Leukemia, Acute, run by University of Malaya at 1 site in Malaysia.

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 3 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 4 Nov 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 Malaysia. 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?

World Health Organization Disability Assessment Schedule (WHODAS) 2.0 (time frame: 30 days ago from interview date). 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 NCT04236063, which also lists 9 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 4 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in