Quality of Life and Emotional Well-being in Patients with cancer metastasis associated compression of spinal cord

Not yet recruiting

Conditions: Neoplasms,

Registration Number: CTRI/2024/10/075773

Lead Sponsor: Dr BRA IRCH AIIMS New Delhi

Brief Summary: After getting clearance from the Institute Ethics Committee, patients attending the pain and palliative care department with a diagnosis of Metastatic spinal cord compression will be recruited in the study. Patients will be explained about the study protocol and informed consent will be taken. The patientâ€™s demographic data including the age, gender, primary cancer, treatment history, duration of disease, details of analgesics, specific symptoms of MSCC , if any treatment was given for the same etc. will be recorded in a predesigned proforma.

Patient will be asked in detail about the various complaints which impact the QOL or the outcome using a questionnaire-based validated scale of European Organization for Research and Treatment of Cancer general cancer QOL Score 30 (EORTC QLQ C-30) .Emotional well being will be assessed using Hospital anxiety and depression score.

Patients will continue to receive therapy deemed necessary by the oncologists. The treatment being received will be noted.

All patients recruited in the study will be assessed at baseline using EORTC-QLQ 30, HADS, KPS and NRS, and also on their follow up visits at 10 days and 1st month. The patientâ€™s treatment and analgesics will also be recorded at their follow up visits. Their mobility, bladder control, place of care will also be noted. Complete privacy and anonymity will be maintained while filling up the questionnaire.

Statistical analysis

Data will be analysed using STATA 14 and SPSS 16. Baseline, patient characteristics will be summarised with mean (SD) or median (25th â€“ 75th percentile) for continuous as well as ordinal variable, Number in percentage or categorical.

The proportion of well being (Score >/=9) at 1 month will be reported with percentage along with 95% confidence interval.

If data of well being score or Quality of Life is normally distributed then we apply the linear mix model with suitable covariance structure. Else non parametric method Friedman followed by Wilcoxon signed rank test. Similarly, for NRS score and performance status at different point will be assessed using Friedman followed by Wilcoxon signed rank and p value adjusted as per Boneferroni correction. P value <0.05 will be considered as significant.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 106

Inclusion Criteria

All patients diagnosed with metastatic spinal cord compression presenting to the Palliative Medicine department during the time period of the study.
All consenting adult patients.

Exclusion Criteria

1.Patients who do not understand Hindi or English 2.Patients in altered mental sensorium 3.
Patients with age less than 18 years.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess emotional well being in patients diagnosed with MSCC at the time of presentation, at 10 days & at 1 month in a tertiary cancer care centre in India	10 days & 1 month

Secondary Outcome Measures

Name	Time	Method
To assess the quality of life in MSCC patients diagnosed at the time of presentation, 10 days & 1 month in a tertiary cancer centre in India	To assess the survival, performance status, pain, mobility and place of care in patients diagnosed with MSCC at the time of presentation, 10 days and 1 month

Trial Locations

Locations (1): All India Institue of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institue of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Anjali P Govind
Principal investigator
7022889298
agovind.964@gmail.com