| CTRI Number |
CTRI/2015/09/006192 [Registered on: 16/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF A NURSING INTERVENTION PROGRAMME(NURSE NAVIGATOR PROGRAMME) IN BREAST CANCER PATIENTS |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE IMPACT OF NURSE NAVIGATOR PROGRAMME(NNP)ON ANXIETY,PSYCHOLOGICAL DISTRESS AND QUALITY OF LIFE OF BREAST CANCER PATIENTS IN A TERTIARY CARE HOSPITAL,KARNATAKA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0514034 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHEJILA C H |
| Designation |
PHD SCHOLAR |
| Affiliation |
MANIPAL COLLEGE OF NURSING MANIPAL ,MANIPAL UNIVERSITY |
| Address |
MANIPAL COLLEGE OF NURSING MANIPAL
MANIPAL UNIVERSITY
MADHAV NAGAR
MANIPAL
UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
08095997753 |
| Fax |
|
| Email |
shejilasajeev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha S Pai |
| Designation |
Professor |
| Affiliation |
MANIPAL COLLEGE OF NURSING MANIPAL ,MANIPAL UNIVERSITY |
| Address |
MANIPAL COLLEGE OF NURSING MANIPAL
MANIPAL UNIVERSITY
MADHAV NAGAR
MANIPAL
UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
09448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
SHEJILA C H |
| Designation |
PHD SCHOLAR |
| Affiliation |
MANIPAL COLLEGE OF NURSING MANIPAL ,MANIPAL UNIVERSITY |
| Address |
MANIPAL COLLEGE OF NURSING MANIPAL
MANIPAL UNIVERSITY
MADHAV NAGAR
MANIPAL
UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
08095997753 |
| Fax |
|
| Email |
shejilasajeev@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIGMA THETA TAU INTERNATIONAL,550 W. North St.
Indianapolis, IN 46202
USA |
|
|
Primary Sponsor
|
| Name |
MANIPAL COLLEGE OF NURSING MANIPALMANIPAL UNIVERSITY |
| Address |
MADHAV NAGAR
MANIPAL
UDUPI
KARNATAKA
PIN CODE:576104 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SIGMA THETA TAU INTERNATIONAL HONOR SOCIETY OF NURSING |
550 W. NORTH STREET – INDIANAPOLIS, IN 46202 USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR STANLEY MATHEW |
KASTURBA HOSPITAL,MANIPAL |
SF1,SF2,SF3 & SF4 WARDS,
DEPARTMENT OF GENERAL SURGERY AND DEPARTMENT OF SURGICAL ONCOLOGY,
KASTURBA HOSPITAL MANIPAL,MADHAV NAGAR,
MANIPAL
UDUPI,KARNATAKA
PINCODE:576104
Udupi
KARNATAKA |
09844409900
stan_mathew@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
BREAST CANCER, (1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NURSE NAVIGATOR PROGRAMME (NNP) |
Nurse Navigator Programme (NNP) is patient navigation service implemented by a masters –prepared nurse who Identify patients those who are newly diagnosed with cancer.The programme includes
1.Preopertive teaching programme of 45 mts given on the day before surgery.
2.Progressive muscle relaxation training for 18mts daily for continuous 7days starting from day before surgery.
3.Provision of informational booklets on a)self care after breast surgery b)chemotherapy c)radiation therapy which will be given at the time of dischage of patient after surgery
|
| Comparator Agent |
ROUTINE CARE |
The patients randomized to control group will receive usual routine care provided to all patients receiving cancer treatment. Usual care is not organized in a formally coordinated model. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
•Women with stage (0, I, II, III) breast cancer
•Women who are undergoing Modified Radical Mastectomy and breast conserving surgeries followed by adjuvant chemo or radiation therapy
•Women in the age group of 25-75 years
•Women who are undergoing breast cancer surgery for the first time
•Subjects who are willing to give consent
|
|
| ExclusionCriteria |
| Details |
•Women with stage IV cancer
•Women with concurrent malignancies
•Women who have received neoadjunct chemotherapy
•Women with severe cognitive impairment or psychiatric illnesses
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE |
AT THE TIME OF ADMISSION,AT TIME OF DISCHARGE,AT THE TIME OF FIRST ADJUVANT THERAPY,AT MIDDLE OF ADJUVANT THERAPY,AT THE COMPLETION OF ADJUVANT THERAPY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANXIETY,PSYCHOLOGICAL DISTRESS |
AT THE TIME OF ADMISSION,AT TIME OF DISCHARGE,AT THE TIME OF FIRST ADJUVANT THERAPY,AT MIDDLE OF ADJUVANT THERAPY,AT THE COMPLETION OF ADJUVANT THERAPY |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2015 |
| Date of Study Completion (India) |
30/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Shejila, C. H., Pai, M. S., Fernandes, D. J., Mathew, S., Chakrabarty, J., Devi, E. S., & George, A. (2017). Psychological Impact of Cancer Diagnosis in Newly Diagnosed Breast Cancer Patients. Indian Journal of Public Health Research & Development, 8(3),
2. Chillakunnel Hussain Rawther, S., Pai, M. S., Fernandes, D. J., Mathew, S., Binu, V. S., Chakrabarty, J., ... & Nayak, B. S. (2017). A Randomized controlled trial to evaluate the impact of a Nurse Navigator Programme on outcomes of people with breast cancer: study protocol. Journal of Advanced Nursing, 73(4), 977-988.
3 C H Shejila, M. S., Pai, M. S., Fernandes, D. J., George, A., Nayak, B. S., Devi, E. S ... & Mathew, S. (2014). Anxiety in breast cancer patients, undergoing surgery as a primary treatment modality. Asia Pacific Journal of Research Vol: I Issue XX.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of the study was to evaluate the effectiveness of a Nurse Navigator programme on anxiety, psychological distress and quality of life of women with breast cancer. The design adopted for the study was a single centre RCT.120 women with newly diagnosed breast cancer and who were admitted in surgical wards of a tertiary care hospital was recruited.iIntervention group received nurse navigator programme and control group received routine care. outcome variables were collected at 5 different time points: before surgery, at discharge, beginning of adjuvant therapy, middle of adjuvant therapy and at the end of adjuvant therapy. The results of the study revealed that there was significant change in anxiety, psychological distress and quality of life of patients. The significant findings were: there was a reduction in anxiety and psychological distress and an improvement in the quality of life scores in the experimental group. Hence it was concluded that the nurse navigator programme was effective. |