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Development of Quality of Life Questionnaire in Gastric Cancers

Phase 1
Conditions
Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Registration Number
CTRI/2021/02/031117
Lead Sponsor
niversity of Southampton
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Histologically proven as gastric adenocarcinoma with disease stages I-IV (UICC TNM 8th)

2. Patients with a gastric or junction cancer whose epicenter is located within 2 cm of the

oesophagogastric junction

3. Patients receiving treatment(either currently or within the last 12 months) including a systemic

treatment (chemotherapy, target agents, and immunotherapy), surgical resection, and radiotherapy or receiving supportive or palliative care

4. Patients who are willing and able to give fully informed consent to participate

5. Patients who are literate in English or Hindi

Exclusion Criteria

1. Patients under 18 years of age

2. Patients with a concurrent malignancy

3. Cancer survivors defined as people who have completed treatment with curative intent more than 12 months ago and are now cancer-free.

4. Patients enrolled in other quality of life studies which will affect the results of the current study

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Phase 1: To compile an exhaustive list of relevant QOL issues covering new treatments and different cultural perspectives from 3 sources namely, literature, patients and health care professionals. <br/ ><br>Phase 2: To develop a provisional module and to ensure that the proposed changes are in line with recommended EORTC QLG guidelines.Timepoint: 12 months
Secondary Outcome Measures
NameTimeMethod
Phase 3: To administer EORTC-QLQ-C30 plus the provisional updated module to patients. <br/ ><br>Phase 4: Field test in large international groups of patientsTimepoint: Day 1 of enrolment into the study
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