Psychoeducational Program for Cancer Patients.

NCT ID: NCT06175195

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-04-10

Brief Summary

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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

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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.

Conditions

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Psychoeducation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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.

Group Type EXPERIMENTAL

Psychoeducational Inervention

Intervention Type 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.

Control Group

Control Group:

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducational Inervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government College University Faisalabad

OTHER

Sponsor Role lead

Responsible Party

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Qasir Abbas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qasir Abbas, PHD

Role: PRINCIPAL_INVESTIGATOR

Government College University, Faislabad.

Locations

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Qasir Abbas

Faisalābad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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GovernmentCUF

Identifier Type: -

Identifier Source: org_study_id