Psychoeducational Program for Cancer Patients.

NCT06175195 | Unknown

• 1 other identifier: GovernmentCUF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study are:

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

Conditions

Psychoeducation

Keywords

Psychoeducational Program.; Treatment refusal; Depressive symptoms; Anxiety; Help-seeking attitude; Cancer Patients

Outcome Measures

Primary Outcomes (5)

• Treatment Refusal

  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

  3-5 weeks

• Depression and Anxiety

  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

  after allocation (1 week)

• Illness denial

  Illness denial will be assessed by using Illness Denial Questionnaire. Higher score indicate high Illness denial whereas low score indicate low illness denial.

  after allocation (1 week)

• Motivation and Help-Seeking attitude

  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.

  after allocation (1 week)

• Quality of Life Scale

  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

  after allocation (1 week)

Secondary Outcomes (2)

• Duration of illness

  at the time of pre assessment (1 week)

• stage of cancer

  after allocation at pre-assessment (1 week)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Experimental Group: Participants in the experimental group would receive 8-10 session of psychoeducational based Program. Waitlist control Group: Participants in the Control group would not receive psychoeducational Intervention.

Behavioral: Psychoeducational Inervention

Control Group

NO INTERVENTION

Control Group: Participants in the control group did not receive the said psychoeducational intervention.

Interventions

Psychoeducational Inervention BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Government College University Faisalabad: lead

Study Sites (1)

Qasir Abbas

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Treatment Refusal; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Qasir Abbas, PHD

  Government College University, Faislabad.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 18, 2023
• Study Start: November 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 10, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)