Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .
Condition: Cancer Patients
Study type: Interventional

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. 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. To compare the knowledge and self efficacy scores in Experimental Vs. Comparison group
           after video assisted SMP among the cancer patients receiving chemotherapy.

        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.

      Secondary Objective To find the correlation between knowledge and self efficacy scores among
      the cancer patients receiving chemotherapy under Experimental Group.

      2. To determine the association of Severity of side effects with the knowledge and self
      efficacy scores among the cancer patients receiving chemotherapy.

      3. To determine the association of knowledge, self efficacy with the socio demographic and
      clinical variables among the cancer patients receiving chemotherapy.

      The study assumes that:

        1. Video assisted teaching is an accepted teaching strategy and enhances teaching learning
           activities.

        2. 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.

        3. 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.
    

Detailed description: 
      Effectiveness A measure of the extent to which a specific intervention, procedure, regimen,
      or service when deployed in the field of routine circumstances, does it intended to do for a
      specific population. (Wojtezak, 2002) In this study, effectiveness refers to the degree to
      which the video assisted SMP is successful in the management of chemotherapy related side
      effects in terms of gain in Knowledge, self efficacy scores and reducing the severity of side
      effects among the cancer patient receiving chemotherapy.

      Video Assisted Self Management Program It referred to an instructional aid which incorporates
      visual and auditory information on a topic for individual to understand and learn. (MedCrave
      2016) In this study it refers to 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.

      Chemotherapy side effects It is the unintended effect occurring at normal dose related to the
      pharmacological properties. (WHO) In this study it refers to the commonly reported
      chemotherapy related side effects by the patients receiving chemotherapy including nausea
      vomiting, Diarrhea, Constipation, Fever, Mucositis, Dry skin, and Alopecia related distress
      in cancer patients after receiving chemotherapy.

      Knowledge It is defined as the familiarity, awareness, or understanding of someone or
      something such as facts, skills or objects. (Plato) In this study it refers to the correct
      response of the patient to the questionnaire regarding the self management of the side
      effects of chemotherapy. It will be assessed by the Structured Questionnaire on self
      management of chemotherapy related side effects with 20 items. The scores will be analyzed in
      the form of means.

      Cancer Patients Cancer Patient is defined as a person receiving or registered to receive
      medical treatment in the Hospital for Cancer. (American Cancer Society) In this study it
      refers to the person either male or female who is suffering from any type of cancer that
      includes but not limited to Head and Neck, Pancreas, Liver, Gall bladder, Breast, Stomach,
      and mouth cancer and receiving chemotherapy at Onco day care ILBS, New Delhi at the time of
      data collection.

      Self Efficacy It refers to an individual's belief in his or her capacity to execute behaviors
      necessary to produce specific performance attainments. It reflects confidence in the ability
      to exert control over one's own motivation, behavior and social environment. (Bandura, 1977)
      In this study it refers to the level of confidence of the cancer patients about their ability
      to manage the chemotherapy related side effects at home. It will be assessed by the
      structured symptom management self efficacy tool consisting of Twelve items. The mean score
      of self efficacy will be used to compare the Experimental and Comparison groups.

      Severity of Chemotherapy Related Side Effects It refers to the degree to which a single side
      effect affects the patient graded on a scale of three. (Aakshdeep batra AIIMS) In this study
      it refers to the magnitude or the intensity (Grading) of the chemotherapy related side
      effects among the cancer patients receiving chemotherapy. It will be assessed by the Common
      Terminology Criteria for the Adverse Events (CTCAE) Version -5 and the Chemotherapy related
      side effects will be assessed in terms of their presence and the severity from the day of
      last chemotherapy cycle to the day of present cycle. It will be a recall basis assessment.

      Hypothesis

      All hypotheses were tested at 0.05 level of significance:

      H1: There will be a significant difference between the Experimental and comparison group in
      terms of their mean gain in knowledge scores after video assisted SMP as assessed by the
      structured knowledge questionnaire.

      H2 : There will be a significant difference between the Experimental and Comparison group in
      terms of their mean gain in Self efficacy scores after video assisted SMP as assessed by the
      self efficacy scale.

      H3: There will be a significant difference between the Experimental and Comparison group in
      terms of their mean scores of Severity of the side effects after video assisted SMP as
      assessed by the CTCAE criteria.

      H4: There will be a significant correlation of knowledge and self Efficacy scores in
      Experimental group among the cancer patients receiving chemotherapy.

      H5: There will be a significant association of severity of chemotherapy related side effects
      with the knowledge and self efficacy scores among the cancer patients receiving chemotherapy.

      H6: There will be a significant association of knowledge and self efficacy scores with the
      sociodemographic and clinical variables among the cancer patients receiving chemotherapy.

      Delimitations of the study The study was delimited to

      • Patients who are receiving chemotherapy at Oncology Day care in ILBS, New Delhi.

      Variables under Study Independent Variables In the present study, the independent variable
      was the Video assisted Self Management Program. The protocol used in this study was prepared
      after an extensive review of literature.

      Dependent Variables In the present study, the dependent variables were Knowledge, self
      efficacy and severity.

      Socio Demographic Variables In the present study, the socio demographic variables studied
      were Age, Gender, Marital status, Education, Occupation, Religion, Family monthly income.

      Clinical Variables The clinical variables are Type of Cancer, duration of time since
      diagnosis, Last chemotherapy cycle received, Stage of cancer , No of present chemotherapy
      cycle received, Any Family members/ closed relatives / friends received chemotherapy ever ,
      Any training received on management of side effects.

      Research Settings The setting for the present study is Institute of Liver and Biliary
      Sciences. It is a super specialty hospital specialized in Liver and biliary sciences .The
      hospital has facilities like Emergency Unit, Transplant Intensive care Unit, Operation
      Theatres, Liver coma Intensive care Unit. The hospital also has the facility of Onco Day care
      where chemotherapy is provided.

      The study was conducted at the Oncology Day care. The Oncology Day care unit is a 9 bedded
      unit. The rationale for selecting the setting was easy availability of the sample of interest
      , feasibility of conducting the study and familiarity with the setting.

      Intervention Description of Video Assisted Self Management Program It is a intervention which
      was designed by the principal investigator In this study it refers to 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. After extensive review of literature under the guidance of guide and Medical
      Oncologist. The Video Assisted teaching program was validated by the Medical oncologist and
      other experts.

      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.
    

Intervention name(s): Video Assisted Self Management Program; Standard of care
Intervention type(s): Other; Other
Intervention description(s): 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.; Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Video Assisted Self Management Program; Knowledge; Self Efficacy; Cancer Patients; Chemotherapy; Severity