Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Quality of Life

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.

Control Group:

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

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.

Psychoeducational Inervention

Qasir Abbas, PHD

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.

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.

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.

Psychoeducational Program for Cancer Patients.

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

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

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 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

They will be assessed through interview information

They will be assessed through history taking information

Government College University Faisalabad

Principal Investigator

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Participants will have two (2), 60 minute, individual sessions with a nurse practitioner via videoconferencing (in person or via telephone) and complete three (3) questionnaires at the time of enrollment, 1-month post-baseline, and 3-months post-baseline.

One-to-One virtual (videoconference) behavioral intervention.

Culturally Aware Adjuvant Endocrine Therapy (AET) Non-Initiation Intervention

Jamie M Jacobs, PhD

Leticia Varella, MD

Jamie M Jacobs, Phd

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

This is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not begun taking adjuvant endocrine therapy (AET) to initiate the medication.

The research study procedures include:

* screening for eligibility
* two individual study intervention sessions
* study assessment follow-up questionnaires

This research study involves two individual sessions with a nurse practitioner which will take place via videoconferencing sessions either in-person or via telephone. Participants will also complete three brief questionnaire packets over the 12-week course of the study.

It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.

Culturally Aware AET Non-Initiation Intervention

Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy With a Culturally Informed-Intervention

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility will be demonstrated by enrollment (\>50% of eligible and approached patients will enroll), retention (\>70% of enrolled participants will complete the two intervention sessions) and attendance (≥70% of participants completing at least one session).

Acceptability will be demonstrated by \>75% of participants reporting average satisfaction scores greater than the mid-point of the Client Satisfaction Questionnaire. The total score range is 3-12, with higher scores indicating a better outcome.

Following the intervention, participants will be more likely to have started their AET. AET initiation will be measured by self-reported questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychoeducational Program for Cancer Patients.	NCT06175195	Psychoeducation	Psychoeducation...	20 Years - 70 Years	Government College University Faisalabad
Culturally Aware AET Non-Initiation Intervention	NCT05465408	Breast Cancer Survivorship Treatment Compl... Treatment Adher... Treatment Refus...	Culturally Awar...	18 Years -	Massachusetts General Hospital
Psychoeducational Program for Cancer Patients.	NCT06175195	Psychoeducation	Psychoeducation...	20 Years - 70 Years	Government College University Faisalabad

Spots Global Cancer Trial Database for treatment refusal