Psychoeducational Program for Treatment Refusal, Psychiatric Symptoms and Quality of Life Among Cancer Patients: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Treatment Refusal
研究概览
简要总结
The main objective of the study are:
- To explore the effectiveness of psychoeducation program for cancer patients who refuse treatment because of irrational fears and anxieties.
- To explore the effectiveness of psychoeducation program for cancer patients who have negative attitudes, and low motivation toward treatment which causes depression and affects the quality of life.
详细描述
Participants:
In this Randomized control trial, N=200 participants would be enrolled for eligibility assessment from different cancer hospitals in Faisalabad and Lahore. 60 participants after the eligibility assessment and screening would be allocated to experimental and waitlist treatment conditions. Participants would be allocated through matchable group characteristics. In experimental group, the diagnosed patients of cancer who refuse psychotherapy would be included and 08 to 10 sessions of psychoeducation program would be provided. In waitlist treatment condition, diagnosed cancer patients would be taken. Each of the group will be comprised of n= 30.
Elegibility Criteria:
The participants that would be taken in the study would be diagnosed patients of cancer with stage I, II and III who refused psychological treatment as recommended by the practitioner. Second eligibility criteria of the participants would be at least mild score on PHD-9 to cross check the mental health problems. The patients would be taken from lower, middle and upper socioeconomic status and their age range would be from 20-70 years. The patients diagnosed with 4th stage would be excluded.
Interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who will be diagnosed with cancer at stage-I, II and III and who have refused medical and psychological treatment will be included in the treatment
- •The second eligibility criterion of the participants would be at least mild score on PHD-9 to cross-check the mental health problems Participants they have diagnosed by the consultant after proper medical screening and evaluation will be included
- •The patients would be taken from lower, middle and upper socioeconomic status.
- •Their age range would be from 20-70 years.
排除标准
- •Participants with medical and psychiatric comorbidities will be excluded
- •The patients diagnosed with 4th stage would be excluded. Participants with serious medical condition will be excluded
结局指标
主要结局
Treatment Refusal
时间窗: 3-5 weeks
Initially, we will enroll the patients for eligibility assessment and the eligible patients who are refusing medical (Chemotherapy, Radiation and Surgery) and psychological treatment (Counseling, psychotherapy) will be referred for psychological evaluations
Illness denial
时间窗: after allocation (1 week)
Illness denial will be assessed by using Illness Denial Questionnaire. Higher score indicate high Illness denial whereas low score indicate low illness denial.
Motivation and Help-Seeking attitude
时间窗: after allocation (1 week)
Motivation will be assessed by using Motivation and attitude towards changing health Scale. Higher score indicate higher motivation whereas low score indicate low motivation. Mental Help seeking attitude will be assessed by using Mental Help Seeking Attitude Scale. Higher score indicate high mental help seeking attitude whereas low score indicate low mental help seeking attitude.
Quality of Life Scale
时间窗: after allocation (1 week)
Quality of Life will be measured by World Health Organization Quality of Life BREF. Higher score indicate high quality of life whereas low score indicate low quality of life
Depression and Anxiety
时间窗: after allocation (1 week)
Depression will be assessed by using Patient Health Questionnaire-9. A Score of 5, 10, 15, and 20 correspond to categorizations of mild, moderate, moderately severe, and severe depression respectively. Hospital Anxiety and Depression will be assessed by using Hospital Anxiety and Depression Scale. A score of 0-7 is considered normal, 8-10 as borderline and 11-21 as either anxious or depressed
次要结局
- stage of cancer(after allocation at pre-assessment (1 week))
- Duration of illness(at the time of pre assessment (1 week))
研究者
Qasir Abbas
Principal Investigator
Government College University Faisalabad