Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .

NCT05368116 | Completed DMC

• 1 other identifier: ILBS-VASMPCa-103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the effectiveness of video assisted Self Management Program on chemotherapy side effects in terms of Knowledge, Self Efficacy and Severity of side effects among the Cancer patient receiving chemotherapy at Oncology day care ILBS , New Delhi. Primary Objective:

1. 1.To assess the Knowledge, Self Efficacy and Severity of side effects of chemotherapy related side effects in the Experiment Vs. Comparison group among the cancer patients receiving chemotherapy.
2. 2.To compare the knowledge and self efficacy scores in Experimental Vs. Comparison group after video assisted SMP among the cancer patients receiving chemotherapy.
3. 3.To compare the severity of chemotherapy related side effects in Experiment Vs. Comparison group before and after video assisted SMP among the cancer patients receiving chemotherapy.
4. 4.Video assisted teaching is an accepted teaching strategy and enhances teaching learning activities.
5. 5.Patients may have limited knowledge about the management of side effects related to chemotherapy including nausea, vomiting, diarrhea, Constipation, dry skin, fever, alopecia related distress and pain.
6. 6.Patients may have decrease severity of chemotherapy related side effects including nausea, vomiting, diarrhea, Constipation , dry skin, fever , alopecia related distress and pain. After the self management program.

Conditions

Cancer Patients

Keywords

Video Assisted Self Management Program; Knowledge; Self Efficacy; Cancer Patients; Chemotherapy; Severity

Outcome Measures

Primary Outcomes (3)

• Knowledge regarding the management of chemotherapy related side effects.

  A structured 20 item knowledge questionnaire developed for assessment of knowledge among the cancer patients receiving chemotherapy at Onco day care Ilbs. The knowledge questionnaire will be self reported by the subjects.

  up to 5 weeks

• self efficacy in relation to symptom management relevant to chemotherapy for patients with cancer.

  The Structured Symptom-Management Self-Efficacy Scale derived from - Symptom-Management Self-Efficacy Scale Breast Cancer (SMSES-Breast Ca.) It was developed by SY Liang et al., in 2015 that measure perceived self efficacy in terms of respondent's ability to self manage the symptoms of chemotherapy. It is an 11-point Likert scale was used for each item that ranged from 0 (not confident at all) to 10 (completely confident), with higher scores representing higher perceived self-efficacy.

  up to 5 weeks

• Severity of Side effects including Nausea, Vomiting, Diarrhea, Constipation, Mucositis, Fever, Pain ,Dry Skin and alopecia related distress.

  It consists of grades which are used to assess the severity of adverse events. Grades ranges from 0 to 5. The scores assessed by the researcher for the severity of side effects will be verified by the doctors on duty. The Distress thermometer was developed as a simple tool to effectively screen for symptom of Alopecia related distress. It is a self reported tool using a 0-10 rating scale. The scale was explained to all the participants and participants were asked to circle or pick a number 0-10 from the drop down box that best describes how much distress patient have been experiencing in the past weeks including today.

  up to 5 weeks

Study Arms (2)

Video Assisted Self Management Program

EXPERIMENTAL

It is the systematically designed Video Assisted teaching program to educate cancer patients receiving chemotherapy under the experimental group about the management of chemotherapy related side effects at home .It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including Nausea, vomiting, Diarrhea, Constipation, Fever, Mucositis, Skin changes, and Alopecia related distress.

Other: Video Assisted Self Management Program

Standard of Care

ACTIVE COMPARATOR

The participants were given video when they come to oncology day care and instruct the participants to watch the video at home. Knowledge, self efficacy and severity of chemotherapy related side effects were assessed after one week.

Other: Standard of care

Interventions

Video Assisted Self Management Program OTHER

The main aim of this intervention is to educate the cancer patients receiving chemotherapy regarding the management of chemotherapy related side effects. It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including nausea vomiting , Diarrhea , Fever , Mucositis , Skin changes , and Alopecia related distress. The participants were given video when they comes to the Oncology day care and researcher instructs the participants to watch the video and at the same time the doubts asked by the participants were cleared by the researcher.

Video Assisted Self Management Program

Standard of care OTHER

Standard of care

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the cancer patients receiving chemotherapy at Onco day care ILBS which will be included in the study who-
• Were 18 years or older
• Patients who have undergone at least one chemotherapy cycle.
• Patients who are stable.
• Can Communicate in English / Hindi
• Patients who are Mentally alert

You may not qualify if:

• All cancer patients undergoing chemotherapy was excluded from the study who -
• Patients who are Android mobile users Patients with visual and hearing impairments
• Had hemodynamic instability.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Seema Ms Bisht, Nursing

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 10, 2022
• Study Start: November 1, 2021
• Primary Completion: November 14, 2021
• Study Completion: December 5, 2021
• Last Updated: May 20, 2022

Record last verified: 2021-03

Locations

IN (1)