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临床试验/CTRI/2024/01/061583
CTRI/2024/01/061583尚未招募不适用

“Effectiveness of video based educational program on cancer related fatigue among breast cancer patients receiving chemotherapy: A Quasi-experimental study”

Non Sponsorship1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
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.

研究概览

简要总结

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

Thepatient 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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: fatigue level will be assessed immediately after collecting baseline data ( 0 days) and after 1 month of giving the videobased intervention.

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Non Sponsorship
申办方类型
Other [Study is sponsored by researcher own]
责任方
Principal Investigator
主要研究者

Koyel Mandal

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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