| CTRI Number |
CTRI/2024/01/061583 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video based educational program ] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of video based educational program on cancer fatigue among patients with breast cancer |
|
Scientific Title of Study
|
“Effectiveness of video based educational program on cancer related fatigue among breast cancer patients receiving chemotherapy: A Quasi-experimental study†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koyel Mandal |
| Designation |
Post Graduate Student |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Marudhar industrial area, 2nd Phase, Basni, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8942926642 |
| Fax |
|
| Email |
mandalkoyel2601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vandna Pandey |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Marudhar industrial area, 2nd Phase, Basni, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
Jodhpur, 342005
India |
| Phone |
9309398688 |
| Fax |
|
| Email |
pandeyv@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandna Pandey |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Marudhar industrial area, 2nd Phase, Basni, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
Jodhpur, 342005
India |
| Phone |
9309398688 |
| Fax |
|
| Email |
pandeyv@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Non Sponsorship |
| Address |
Non Sponsorship |
| Type of Sponsor |
Other [Study is sponsored by researcher own] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Non sponsored |
Non Sponsored |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandna Pandey |
All India Institute of Medical Sciences, Jodhpur |
College of Nursing, AIIMS Jodhpur, Marudhar industrial area, 2nd Phase, Basni. Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN |
9309398688
pandeyv@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Care |
Treatment Provided by Oncology Department of AIIMS Jodhpur will be given and observed for 1 month of duration. |
| Intervention |
Video based education program on cancer related fatigue. |
Video based educational program is refers to providing education regarding management of cancer related fatigue to the patients through a video containing causes/risk factors, all self-management general strategies, low intensity exercise program, and nutritional management etc
It will also contain about
Energy conservation Priority wise goal set, self pacing of work etc.
The intervention will be given to the patient for 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients
-having age above 18 years and diagnosed breast cancer.
-receiving chemotherapy and completed at least one cycle of their chemotherapy
-willing to participate in the study.
-can able to understand and communicate in Hindi or English.
|
|
| ExclusionCriteria |
| Details |
Patients
-with a history of psychiatric or neurological disorders that may affect fatigue perception (e.g., depression, anxiety, sleep disorders etc.)
-with hearing or visual impairments that may interfere with the comprehension of the video-based educational program.
-diagnosed with secondary metastatic breast cancer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue level of the patients with breast cancer who have completed at least one cycle of chemotherapy will be assessed before and after of video based intervention through VAS-F fatigue scale. |
fatigue level will be assessed immediately after collecting baseline data ( 0 days) and after 1 month of giving the videobased intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="1"
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
|
Cancer-related fatigue is defined as a distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning. The severe exhaustion compromises the everyday life of affected patients and survivors of cancer. The severe exhaustion
compromises the everyday life of affected patients and survivors of cancer. A
recent study shows that the current analysis
indicates an overall pooled prevalence of cancer-related fatigue of 52%.A recent study shows that breast cancer survivors with
stage II or III cancer, treated with chemotherapy were at higher risk for
severe fatigue than breast cancer survivors with stage 0 or I cancer and
without chemotherapy. Cancer-related fatigue is a common problem in oncology patients and the survivors that has received attention during the last two decades. Breast cancer is one of the most common cancers in women worldwide and chemotherapy is a standard treatment option for breast cancer patients, and it can have various side effects, including physical, emotional, and cognitive symptoms. The purpose of video based educational program focused on cancer-related fatigue in breast cancer patients who are receiving chemotherapy because the problem is very common but most likely unseen especially in women. It is hoped that patient can be beneficial in managing this symptom by seeing the video in easy language. Such a video can provide patients with information about the causes of cancer-related fatigue, strategies to manage it, and the importance of physical activity and rest in reducing fatigue in individuals who are receiving chemotherapy. The main purpose of the study is to compare the effectiveness of the sequenced video based learning program in experimental group in respect to control group. 1.Research approach: Quantitative Research Approach. 2. Research design: Quasi Experimental, Non- equivalent control group pre-test post-test design. 3. Research setting: Chemotherapy units, All India Institute of Medical Sciences (AIIMS) Jodhpur, Rajasthan. 4. Target population: Target population of present study comprised of patients with breast cancer who are receiving chemotherapy and completed at least one cycle of their chemotherapy regimen.Data collection tools :The data will be collected through mainly with two tools. one for collecting baseline characteristics and clinical profile and second tool is standardize that is for collecting fatigue score.
Data collection procedure STEP 1: Enrolment The patient diagnosed with the breast cancer receiving chemotherapy treatment from chemotherapy units and completed one cycle will be informed and written consent will be obtained from the patients for conducting the study, and the patients will be informed about the follow-up check-up requirement. STEP 2: Baseline Data collection The baseline data will be collected from the enrolled patients which will include the Socio-demographic Variables (age, Education level of patient, Marital status, Employment status, travel distance from home to hospital etc.) and Clinical Variables (BMI, Stages of Cancer, Any Comorbidities, Chemotherapy regimen, Chemotherapy cycle completed, blood investigation etc.) STEP 3: Non-random allocation of participants to both groups Initially enrolled chemotherapy receiving patients will be assigned to control group and then after the completion of baseline data collection about fatigue and informing about follow-up the post-test fatigue score will be assessed. and then the experimental group data will be collected from baseline and as well as the post-test will be conducted after giving intervention to avoid the biasness. STEP 4: Intervention Control group participants will receive the standard treatment as per oncology department. Experimental group participants will receive video based educational program on Cancer related fatigue along with the standard treatment. The video based educational program will contain causes/risk factors, all self-management general strategies, low intensity exercise program, and nutritional management etc. Video will be educated, then send through WhatsApp and Telephonic reinforcement will be done to the experimental group after receiving intervention. General Strategies for Management of Fatigue Self-monitoring of fatigue level, Energy conservation, Set priorities and realistic, Pace ,Schedule activities at time of peak energy, Labour-saving devices, Postpone nonessential activities, Limit naps to <1 hour to not interfere with night- time sleep quality, Structured daily routine Attend to one activity at a time, Use distraction (eg, games, music, reading, socializing) Find meaning in current situation,Emphasis on meaningful interactions Promote dignity of patients ,Consider referral to appropriate specialist or supportive care provider. STEP 5: Post-intervention data collection After 4 weeks post-intervention, fatigue scale will be administered on both control and experimental group by questionnaire and direct face to face interview method will be used for collecting data. STEP 6: Data analysis Thereafter, collected data will be coded and entered in master sheet for analysis. Plan for data analysis Statistical analysis will be performed using statistical package for social sciences program SPSS version 20 With Descriptive and inferential statistics. Duration of study The study will be completed in a period of 1 year.
|