Impact of CALM therapy:Advanced Cancer and Living Meaningfully-a psychological intervention in advanced gynecological cancers.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To assess the impact of CALM therapy intervention on depression and on anxiety in advanced gynecological cancer patients.
Study Overview
Brief Summary
Depression and anxiety is a very common in advanced gynecological cancer patients.CALM therapy is an acronym for Advanced Cancer and Living meaningfully.CALM therapy is a validated therapy to improve the quality of life in cancer patient.Many trials have been conducted assessing the effectiveness of CALM therapy.Advanced stage gynecological cancer patients will be recruited and randomised into case and control.Baseline assessment of deprerssion and anxiety and their current quality of life will be assessed by validated psychological questionarres like GAD 7,PHQ 9 and QUAL -EC.CALM therapy will be given to patients in case group -minimum 3-6 sessions will be given.Reassessment will be done at the end of 3 months and 6 months for all patients in control and case group and effectiveness of CALM therapy over depression,anxiety and quality of life of cancer patients will be assessed.CALM therapy is already studied by Rickinder sethi et al.,Gary Rodin et al.,Christopher lo et al.,and many others.In all these studies there was no adverse effect documented and found to be beneficial in cancer patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Advanced gynecological cancer patients without any previous history of pshychological disorders and who are influenced in Malayalam and English.
Exclusion Criteria
- •Early stage gynecological cancer patients and not influent in english and malayalam and not consenting for the study.
Outcomes
Primary Outcomes
To assess the impact of CALM therapy intervention on depression and on anxiety in advanced gynecological cancer patients.
Time Frame: Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months
Secondary Outcomes
- To calculate the incidence of depression and on anxiety in advanced gynecological cancer patients and to assess the impact of CALM therapy intervention on quality of life in cancer patients and to evaluate the effectiveness of CALM therapy and to assess the possibility of executing CALM therapy as a usual routine care in our institute(Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months)
Investigators
Dr Deepika Rajkumar
Amrita Institute of medical science,Amrita Vishwa vidhyapeetham