| CTRI Number |
CTRI/2024/11/077194 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find the effectiveness of psychosocial therapies given by nurse to improve quality of life and decrease the symptoms of depression and anxiety among women diagnosed with breast cancer in a selected hospital of Sikkim |
|
Scientific Title of Study
|
Effectiveness of Nurse-Led Psychosocial Intervention (NLPI) on Quality of life, Depression, and Anxiety among women with breast cancer in a selected hospital of East Sikkim: A Randomized Controlled Trial |
| Trial Acronym |
NLPI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazung Lepcha |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal College of Nursing, Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Mental Health Nursing,Sikkim Manipal College of Nursing, Level 2 CRH Building ,
Sikkim Manipal University,
5th Mile Tadong
Gangtok
East
SIKKIM
737102
India |
| Phone |
9475614885 |
| Fax |
|
| Email |
nazung.l@smims.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samrat Singh Bhandari |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Psychiatry,Central Referral Hospital,Sikkim Manipal Institute of Medical sciences , Sikkim Manipal University, 5th Mile Tadong, Gangtok ,Sikkim
East
SIKKIM
737102
India |
| Phone |
8348767641 |
| Fax |
|
| Email |
samrat.b@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samrat Singh Bhandari |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Psychiatry,Central Referral Hospital,Sikkim Manipal Institute of Medical sciences , Sikkim Manipal University, 5th Mile Tadong, Gangtok ,Sikkim
East
SIKKIM
737102
India |
| Phone |
8348767641 |
| Fax |
|
| Email |
samrat.b@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing ,Sikkim Manipal University, Level 2 CRH Building , 5th Mile Tadong, Gangtok, Sikkim, India , Pin code - 737102 |
|
|
Primary Sponsor
|
| Name |
Nazung Lepcha |
| Address |
Sikkim Manipal College of Nursing, Sikkim Manipal University, Level 2 CRH Building, 5th mile Tadong , Gangtok , Sikkim,India
Pin Code-737102 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAshish Rai |
Sir Thutob Namgyal Memorial Hospital |
Department of Oncology, Oncology ward , Sochakgang, Gangtok, Sikkim ,India , Pin code -737101
East
SIKKIM |
9593387501
asoorai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Information Booklet |
The intervention group and the control group will be given General Information Booklet about Mindfulness practice, Relaxation training and information regarding breast cancer and treatment before the start of Nurse- led Psychosocial interventions.
Total duration and frequency—the General information booklet will be given once to both group . |
| Intervention |
Nurse-Led Psychosocial Interventions (NLPI) |
The interventions will consist of Mindfulness based stress reduction, Jacobson Progressive Muscle relaxation technique and psychoeducation.
Total durations - 2-3 hours
Frequency - 5 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
With a confirmed diagnosis of non-metastatic breast cancer
Admitted to the oncology ward STNM and undergoing 1st or 2nd cycle of chemotherapy
Who are in stages II, III of breast cancer
Who do not have any other chronic illness such as Chronic Kidney disease ,Chronic Liver disease, Chronic Obstructive Pulmonary Disease and Cerebrovascular accident
Ability to speak and understand either English, Hindi, Nepali and willingly consented to attend all therapy sessions, Who are residing in the Gangtok District, Pakyong District and Mangan District
Who have received the education upto Class 10
Who have scored more than 2 in Hospital Anxiety and Depression Scale
|
|
| ExclusionCriteria |
| Details |
Those who have participated in MBSR, JPMR courses over the past six months,
Diagnosed with Psychiatric disorders,
Pregnant women with breast cancer,
Witnessed adverse life events, including the death of family members, divorce, and spouse abandonment that occurred during the study or the past 6 months,
Who have difficulty understanding the questionnaire or to communicate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quality of life with Functional Assessment of Cancer therapy -Breast FACT B
2.Depression and Anxiety with Hospital and anxiety HADS scale |
Time points will be at baseline, after intervention at 1 week , 6 week, 9 week and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will develop and validate the Nurse led Psychosocial Interventions after extensive review and conducting Focus Group Discussion among healthcare providers and caregiver of breast cancer patients. The female breast cancer patients will be recruited and they will be randomized into intervention group and control group .The developed Nurse led psychosocial interventions module will be given to intervention group in five sessions (one session per week) and then follow up at 6th ,9th and 12th week . Then telephonic follow up will be done every twice a week for about 20 minutes till 6 months. The control group will be given standard care and general information booklet regarding cancer treatment , managing side effects of chemotherapy and stress management. |