| CTRI Number |
CTRI/2024/09/073331 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video-based education program] |
| Study Design |
Other |
|
Public Title of Study
|
A study was conducted to compare the efficacy of a video-based educational program for the management of post-radiotherapy side effects to the standard medical treatment of the side effects in head and neck cancer patients. |
|
Scientific Title of Study
|
Effectiveness of Video-Based Education Program On Post-Radiotherapy Side-Effects Among Patients With Head and Neck Cancer in a Tertiary Care Center: A Quasi-Experimental Study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Pan |
| Designation |
1st Year MSc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Nursing, Seminar room 3, College of Nursing, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9330515886 |
| Fax |
|
| Email |
riyapan98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandna Pandey |
| Designation |
Assistant Professor AIIMS Jodhpur |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9309398688 |
| Fax |
|
| Email |
vandna.pandey80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya Pan |
| Designation |
1st Year MSc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Nursing, Seminar room 3, College of Nursing, AIIMS Jodhpur, Basni Industrial Area, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9330515886 |
| Fax |
|
| Email |
riyapan98@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005, India |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puneet Pareek |
All India Institute of Medical Sciences, Jodhpur |
Oncology Day Care OPD, Room number 5, Department of Radiation Oncology, ground floor, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN |
8118823077
drpuneetpareek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A video-based education program for managing post-radiotherapy side effects. |
An educational video of 9 minutes will encompass various factors, such as self-management techniques, low-intensity exercise programs, and nutritional management for managing common post-radiotherapy side effects like fatigue, weight loss, dysphagia, xerostomia, nausea and vomiting, oral mucositis, and radiation dermatitis.
The video will be provided to the patients for guidance and adherence to the management strategies. A compliance sheet would be maintained to ensure adherence to the intervention. A follow-up assessment of side effects would be done at the end of the first week, the fourth week, and the sixth week after receiving the first radiotherapy. |
| Comparator Agent |
Standard treatment for radiotherapy-induced side effects prescribed by the oncology department will be continued throughout the duration of the study. |
Participants in the control group will receive the routine standard treatment for the management of radiotherapy-induced side effects as prescribed by the oncology department. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with head and neck cancer who are more than 18 years old and attending the Oncology Day Care OPD of AIIMS, Jodhpur.
2) Patients with head and neck cancer attending the Oncology Day Care OPD of AIIMS, Jodhpur, to receive radiotherapy, adjuvant radiotherapy, or neo-adjuvant radiotherapy for the first time.
|
|
| ExclusionCriteria |
| Details |
1) Patients who are not able to follow instructions.
2) Patients who are not willing to participate
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Post-radiotherapy side effects: fatigue, weight loss, dysphagia, xerostomia, nausea and vomiting, oral mucositis, radiation dermatitis |
The post-radiotherapy side effects will be measured at 3 points in time:
Baseline data will be collected at the time of enrolment
Assessment I: One week after receiving the first radiotherapy
Assessment II- At the end of the first month (4 weeks).
Assessment III- At the end of 6 weeks.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Association of selected post-radiotherapy side effects with selected socio-demographic and clinical variables. |
Sociodemographic and clinical data will be collected at the time of enrolment
|
|
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Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
Months="2"
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
|
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Brief Summary
|
Aim of the study This study aims to assess the effectiveness of of video-based educational programs on post-radiotherapy side effects and to determine its association with selected socio-demographic and clinical variables. Objectives 1) To assess and compare the effectiveness of a video-based education program on selected post-radiotherapy side effects among patients with head and neck cancer receiving radiotherapy. 2) To determine the association of selected post-radiotherapy side effects with selected socio-demographic and clinical variables. Hypotheses H01- There will be no significant difference in the post-radiotherapy side effects in experimental and control groups after the administration of video-based education. H02- There will be no significant association of post-radiotherapy side effects and patients with head and neck cancers with selected sociodemographic variables. |