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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236063
Other study ID # 201945-7310
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date May 31, 2020

Study information

Verified date November 2020
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date May 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patient with haematological malignancy - agreeable to participate in the interview Exclusion Criteria: - ill at the time of follow up - unable to understand English, Malay or Chinese - refuse to be interviewed

Study Design


Intervention

Other:
WHODAS 2.0 Questionnaire
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

Locations

Country Name City State
Malaysia University Malaya Kuala Lumpur Wilayah Persekutuan

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (9)

Allart-Vorelli P, Porro B, Baguet F, Michel A, Cousson-Gélie F. Haematological cancer and quality of life: a systematic literature review. Blood Cancer J. 2015 Apr 24;5:e305. doi: 10.1038/bcj.2015.29. Review. — View Citation

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 stud — View Citation

Dietz JH Jr. Rehabilitation of the cancer patient. Med Clin North Am. 1969 May;53(3):607-24. — View Citation

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. — View Citation

Hansen DG, Larsen PV, Holm LV, Rottmann N, Bergholdt SH, Søndergaard 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 — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
30 days ago from interview date
Secondary 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. 30 days ago from interview date
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