Clinical trial NCT06175195: Psychoeducational Program for Cancer Patients.
Official title: Psychoeducational Program for Treatment Refusal, Psychiatric Symptoms and Quality of Life Among Cancer Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychoeducation
Keywords: Psychoeducational Program.
Treatment refusal
Depressive symptoms
Anxiety
Help-seeking attitude
Cancer Patients
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Refusal
timeFrame: 3-5 weeks
measure: Depression and Anxiety
timeFrame: after allocation (1 week)
measure: Illness denial
timeFrame: after allocation (1 week)
measure: Motivation and Help-Seeking attitude
timeFrame: after allocation (1 week)
measure: Quality of Life Scale
timeFrame: after allocation (1 week)
Secondary outcomes:
measure: Duration of illness
timeFrame: at the time of pre assessment (1 week)
measure: stage of cancer
timeFrame: after allocation at pre-assessment (1 week)
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Qasir Abbas
state: Punjab
Study officials:
affiliation: Government College University, Faislabad.
name: Qasir Abbas, PHD
role: PRINCIPAL_INVESTIGATOR
References: