Effectiveness of multi-modal interventions on Quality of life, symptom burdens and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Chaitali Biswas
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of multi-modal interventions on Quality of life, Symptom management and self-efficacy among ovarian cancer pateints
Overview
Brief Summary
This study is a single-center, randomized, parallel-group open trial to assess the effectiveness of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata. The study aims to prepare & implement multi-modal interventions to determine QOL, symptom burdens & self-efficacy among Ovarian cancer patients. The study will follow an RCT design for 9 months of each patient’s coverage. Multi-modal interventions include four multi-component nursing intervention sessions (Pre-treatment session, Sensitization session, Prehabilitation session, and Symptom management session) through various modes of instruction; each session will be on Four different days within the period of 1 to 21 days. It will be given only to the experimental group of ovarian cancer patients undergoing treatment with surgery or chemotherapy to improve their Quality of life and self-efficacy and to reduce their symptom burdens. Multi-modal interventions will be reinforced and monitored through telephonic conversation and in each follow-up visit at the Outpatient department every three months till six months of the treatment.
Standardized tools will be used to collect data as a baseline & every 3-month intervals after the implementation of the intervention for both groups of participants. The study’s primary objective is to evaluate the effect of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients. The secondary outcome is encouraging and motivating the individual to adapt the intervention daily to improve self-efficacy, self-management, and health-related quality of life. Based on the findings, this can be implemented as routine care for ovarian cancer patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 19.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Newly diagnosed Ovarian cancer patients
- •With any stage from II, III, and IV.
- •Eastern Cooperative Oncology group (ECOG) performance status within
- •Planned for initial treatment either with chemotherapy or Surgery.
- •Able to understand, read, and write Bengali or Hindi or English.
Exclusion Criteria
- •Ovarian cancer patients who are
- •Critically ill.
- •ECOG performance status more than
- •Diagnosed as a relapse of ovarian cancer patients.
- •under palliative care.
Outcomes
Primary Outcomes
To evaluate the effect of multi-modal interventions on Quality of life, Symptom management and self-efficacy among ovarian cancer pateints
Time Frame: Quality of life, Symptom burdens, and self-efficacy as the outcome of the multi-modal intervention will be assessed at baseline, 3 month, 6 month and 9 month for both experimental arm and control arm
Secondary Outcomes
- To encourage and motivate the individual Ovarian cancer patients under study to adapt the intervention in their daily life and thus to improve the self-efficacy and self management of symptoms and health related quality of life(at 9 months after the study as well as continue throughout the survival period)
Investigators
Chaitali Biswas
Tata Medical Center