PsychoeducationNCT06175195
Psychoeducational Program for Cancer Patients.
A study testing Psychoeducational Inervention in people with Psychoeducation, run by Government College University Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychoeducation
- What is being tested?
- Psychoeducational Inervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychoeducational Program for Treatment Refusal, Psychiatric Symptoms and Quality of Life Among Cancer Patients: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Psychoeducation
- Being tested
- Psychoeducational Inervention
- Keywords
- Psychoeducational Program., Treatment refusal, Depressive symptoms, Anxiety, Help-seeking attitude, Cancer Patients
- Medical subject headings
- Treatment Refusal, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational InerventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducational Inervention |
| Control Group | No intervention | Control Group: Participants in the control group did not receive the said psychoeducational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: after allocation (1 week)
Secondary outcomes (2)
Duration of illness
They will be assessed through interview information
Measured: at the time of pre assessment (1 week)
stage of cancer
They will be assessed through history taking information
Measured: after allocation at pre-assessment (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Nov 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychoeducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
- Investigators
- Qasir Abbas, PHD, Principal investigator, Government College University, Faislabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175195
- Sponsor's protocol ID
- GovernmentCUF
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducational Program for Treatment Refusal, Psychiatric Symptoms and Quality of Life Among Cancer Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06175195
- Acronym / sponsor ID
- GovernmentCUF
- Conditions
- Psychoeducation
- Keywords
- Psychoeducational Program., Treatment refusal, Depressive symptoms, Anxiety, Help-seeking attitude, Cancer Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Psychoeducational InerventionExperimental 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. |
| Control Group | No intervention | –Control Group: Participants in the control group did not receive the said psychoeducational intervention. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational InerventionPsychoeducational 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. | Behavioural | Treatment Group |
Primary outcome
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
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
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
2 secondary outcomes
Duration of illness
Time frame: at the time of pre assessment (1 week)
stage of cancer
Time frame: after allocation at pre-assessment (1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qasir Abbas, PHD principal investigator
Government College University, Faislabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Inervention in people with Psychoeducation, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Refusal (time frame: 3-5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.