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Clinical Trials/NCT06175195
NCT06175195
Active, Not Recruiting
N/A

Psychoeducational Program for Treatment Refusal, Psychiatric Symptoms and Quality of Life Among Cancer Patients: A Randomized Control Trial

Government College University Faisalabad1 site in 1 country200 target enrollmentNovember 15, 2023
ConditionsPsychoeducation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychoeducation
Sponsor
Government College University Faisalabad
Enrollment
200
Locations
1
Primary Endpoint
Treatment Refusal
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The main objective of the study are:

  1. To explore the effectiveness of psychoeducation program for cancer patients who refuse treatment because of irrational fears and anxieties.
  2. 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.

Detailed Description

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: Psychoeducational Program would be used as an intervention stratégie for cancer patients to provide understanding and insight to the patients about the problems. Further, this program would address treatment refusal and illness denial, depressive symptoms, and treatment related irrational fears and anxiety. Moreover, this program will improve patients' motivation and attitude toward changing health, and quality of life. Expected Outcomes This study would provide valuable information to the mental health practitioners to treat and develop the guidelines and protocol for patients with cancer. Psychoeducational Program played substantial role as supportive intervention to develop insight, motivation and positive attitude toward treatment as well as to enhance adherence to treatment among patients with cancer. And there would be substantial decrease in depression, treatment related fear and anxiety. Moreover, this program will improve patients' motivation and attitude toward changing health, and quality of life.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
April 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qasir Abbas

Principal Investigator

Government College University Faisalabad

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Treatment Refusal

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • stage of cancer(after allocation at pre-assessment (1 week))
  • Duration of illness(at the time of pre assessment (1 week))

Study Sites (1)

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