Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Depression

Depressive Disorder

Brain Neoplasms

Quality of Life

Non applicable

The main aim of this study is to evaluate the impact of head \& neck cancer and brain tumors on lives of patients in Pakistan. To the best of the investigators knowledge this will be the first in-depth study to evaluate resilience and quality of life (QoL) among this group of patients. These patients encounter challenges as they battle to maintain optimistic outlook towards life. Resilience and QoL among them changes over time and may be modifiable towards increased well-being. Resilience and QoL are critical components during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psychological well-being. Through this study the investigators will be able to identify problems faced by such patients in our setting. the investigators will be able to plan appropriate interventions to improve a person's resiliency and quality of life, reduce depression and anxiety, and increase their satisfaction with life. This study is also aimed to inform healthcare providers and researchers regarding protective or risk characteristics for coping with cancer. Practices and resilience interventions may improve well-being and adherence to care guidelines.

The objectives of our study are:

Primary Objectives:

* To determine resilience and quality of life scores after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan.
* To evaluate important factors associated with resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan.

Secondary Objective:

• To examine the relationship between resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan.

It will be an analytical cross sectional study design. The study will be conducted at the Aga Khan University Hospital, Karachi. Study participants will be men and women greater than 18 years, with brain tumors or head \& neck cancer fulfilling the eligibility criteria. Approximately 250 patients will be recruiting with brain tumors and 250 with head \& neck cancer. Validated tools will be used to measure resilience and QoL.

Background In 2012, around 14.1 million new cases of cancer were diagnosed worldwide and another 8.2 million died from cancer. It is estimated that by 2030, these figures could increase to an alarming 26.4 million new cases and 17 million cancer-related deaths. Nearly 56% of the new cancer cases and 64% of the cancer-related deaths occur in low and middle income countries (LMICs), where there is a lack of universally available, affordable, and sustainable health care. Head and neck cancers are among the most common cancers worldwide with nearly 600,000 new cases and 300,000 deaths occurring globally every year. Brain tumors are responsible for approximately 2% of all cancer deaths. The overall incidence of brain tumors is 4-5/100,000 population per year. Cancer's diagnosis considerably affects patient's emotional and psychological status. The cancer survivors encounter various challenges, as they battle to maintain an optimistic outlook towards life. Resilience enables individuals to thrive in the face of adversity and it is believed that resilience plays an important role in a cancer survivor's life to cope with their illness, to overcome depression and improve their Health- related quality of life (HR-QoL). HR-QoL and its assessment have become increasingly important in health care, especially in the field of chronic diseases recently. HR-QoL generally refers to patients' perceptions of the effects of disease on life. It has two fundamental premises; first, a multi-dimensional concept incorporating physical, psychological, social, and emotional functional domains. Second is subjective and must be self-reported, according to the patients' own experiences. Conventionally, the endpoints of medical care for cancer patients had focused on survival rate, local control rate, or complication rate. However, assessments have lacked knowledge and understanding of the patient's mental and emotional wellbeing. Recently, resilience in the course of cancer treatment has been given immense attention. Several studies from different parts of the world on cancer survivors suggest that resilience is a protective factor for distress. A study reported resilience was likely to mediate the adverse relationship between cancer symptoms, distress and QoL for cancer survivors, indicating, resilience might play an essential role in protecting against adverse effects of cancer symptoms on QoL. It is identified, that resilience as an important changeable path can improve hope and QoL. Therefore, it is important that before initiating treatment, patients should be referred to a mental health professional for psychological/psychiatric evaluation. Resilience and QoL is a critical component during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psycho-social well-being. Resilience and QoL changes over time and may be modifiable towards increased well-being. To the best of the investigators knowledge, this will be the first in-depth study to evaluate resilience and quality of life among head \& neck cancer and brain tumor patients in Pakistan. Moreover, through this study the investigators will be able to identify problems faced by such patients in their setting, enabling the investigators in the future to design interventions to improve resilience and QoL.

Resilience and Quality of Life Among Cancer Survivors

Resilience and Quality of Life of Head & Neck Cancer and Brain Tumor Survivors in Pakistan

Resilience will be measured by Wagnild \& Young's 14 Item A high score represents better resilience. The respondent's choice ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). The scale uses total scores rather than scores of individual items.

Quality of life will be measured by European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-C30) AND European Organization of Research and Treatment Of head and Neck cancer (EORTC QLQ-H\&N35) AND European Organization of Research and Treatment Of Brain tumor ( EORTC QLQ-BN20) All of the scales and single-item measures scores range from 0 to 100. A high scale score represents a higher response level.

Aga Khan University

Senior Instructor Research

Anxiety Disorders

Behavioral Symptoms

Participants will receive IntelliCare apps with phone coaching for 7 weeks. In this arm, participants will pick two IntelliCare apps to use every week. Participants will receive a phone coaching call before they use the apps, for approximately 30 minutes, as well as 3 weeks after initiating app use (10 minute call).

IntelliCare is composed of 13 separate, native apps. Each app targets a specific aspect of mental health (e.g., reducing worry, increasing social support, tracking negative thoughts). The apps are available to the public in both Android and iPhone stores. Participants will be asked to try two new IntelliCare apps every week, for 7 weeks. Phone coaching will occur at Day 0, before using any of the apps, and the third week of app usage.

IntelliCare + Phone Coaching

Philip Chow, PhD

Sarah Adams, BA

A cancer diagnosis affects not only patients but also their caregivers. The purpose of this study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the mental health of cancer patients and caregivers.

Cancer patients and/or their caregivers will receive access to the mobile app suite, IntelliCare, as well as phone coaching that will focus on how to use the apps. IntlliCare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). The apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). IntelliCare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.

Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite

Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers

Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive)

How much have you used alcohol or tobacco to cope with negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)

How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely)

1. How connected did you feel to family and friends? (Scale from 1=Not at all to 5=A lot or extremely)
2. How much support did you receive from loved ones? (Scale from 1=Not at all to 5=A lot or extremely)
3. How much were you able to support loved ones? (Scale from 1=Not at all to 5=A lot or extremely)

How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely)

How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely)

How active were you? (Scale from 1=Not at all to 5=A lot or extremely)

How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)

Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive)

Patient-Reported Outcomes Measurement Information System 4-Item Depression Scale (from 29-item Profile), measures depression on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of depression.

Patient-Reported Outcomes Measurement Information System 4-Item Anxiety Scale (from 29-item Profile), measures anxiety on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of anxiety.

Patient Health Questionnaire-4 contains measures clinical symptoms of mood and anxiety disorders. Scores on this scale range from 0-12, with a higher score indicating greater severity of mood symptoms. Unlike the Patient-Reported Outcomes Measurement Information System scales, this scale has pre-determined clinical cutoffs for mild, moderate, and severe symptoms, which will be used to classify severity of mood symptoms.

Patient-Reported Outcomes Measurement Information System 4-Item Physical Function Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating less impairment of physical function.

Patient-Reported Outcomes Measurement Information System 4-Item Life Meaning and Purpose Scale. Scores on this scale range from 4-20, with a higher score indicating more life meaning and purpose.

Patient-Reported Outcomes Measurement Information System 4-Item Sleep Disturbance Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more sleep disturbance.

Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more fatigue.

Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more pain interference in daily life.

Created a scale since none currently exist. Items (in order) are the following:

1. Over the past two months, how many times did you go to the emergency department?
2. Were any of these visits related to your side effects from cancer treatment? (Yes/No/I Don't Know)
3. How many visits were related to side effects from cancer treatment?
4. Over the past two months, did you ever miss a scheduled appointment for cancer treatment? (Yes/No/I Don't Know)
5. How many appointments did you miss?
6. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to cancer treatment. (Yes/No/I Don't Know)
7. What types of services have you used?

Created a scale since none currently exist. Items (in order) are the following:

1. Over the past two months, how many times did you go to the emergency department?
2. Over the past two months, how many times did you visit your primary care doctor for anything OTHER THAN routine care?
3. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to caregiving for your loved one with cancer. (Yes/No/I Don't Know)
4. What types of services have you used?

Patient-Reported Outcomes Measurement Information System 4-Item Ability to Participate in Social Roles and Activities Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more ability to participate in social roles and activities in daily life.

Caregiver Self-Efficacy Scale (CaSES; Ugalde, Krishnasamy, \& Schofield, 2013). A 21-item scale developed to measure self-efficacy in informal cancer caregivers. Scores range from 0-84, with a higher score indicating more self-efficacy.

University of Virginia

Assistant Professor

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Thyroid Diseases

Diabetes Mellitus

Metabolic Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.

Nutritarian Diet-style: Daily consumption of greens, beans/legumes, a variety of other vegetables, fresh or frozen fruits, nuts, seeds and whole grains. Participants are encouraged to minimize consumption of refined grains, vegetable oils, processed foods, and to limit animal products.

Nutritarian Diet-style

Jay Sutliffe

The Nutritarian Women's Health Study (NWHS) is a long-term hybrid effectiveness-implementation study on the effect of the Nutritarian Diet on the occurrence, recurrence, and progression of chronic diseases (including all forms of cancer and cardiometabolic risk factors).

The Nutritional Research Foundation, in conjunction with Northern Arizona University, is conducting a long-term health study for women ages 18 and older. This study will address the effects of a nutrient dense, plant-rich diet on the long-term risks of cancer and other chronic diseases.

Participants enroll in a 30-day training module which outlines the benefits of a nutrient-dense, plant-rich diet. At the conclusion of those videos and written modules, they take a short quiz to assess their knowledge and they can enroll in the full study.

All participation is online with ongoing modules on nutrition and lifestyle. There is a comprehensive health history and lifestyle index to be completed. Nutrition questionnaires will be administered an average of every 3-6 months; PHQ-9 (Patient Health Questionnaire) \& PSQI (Pittsburgh Sleep Quality Index) questionnaires an average of every 12 months; serum cardiometabolic measures and liquid biopsies an average of every 18 months.

A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer

Nutritarian Women's Health Study to Reduce Chronic Disease

We are considering making this data available to other researchers after we have a substantial number of participants enrolled.

Adherence to the recommended dietary protocol with the Nutritarian Health Indicator (©Joel Furhman MD). Scored by points (90-100 excellent, 80-89 good, 70-79 average, \<69 poor).

Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m\^2.

Self-measured and reported measurements in inches.

PHQ-9 (Patient Health Questionnaire-9). Tool designed for screening, diagnosing, monitoring and measuring the severity of depression. Scoring: 5-9 (minimal symptoms), 10-14 (minor depression, dysthymia, mild major depression), 15-19 (major depression, moderately severe), and \>20 (major depression, severe).

PSQI (Pittsburgh Sleep Quality Index). Tool designed to evaluate sleep quality over a 1 month interval. Scoring 0-21 points. Any score \>5 indicates sleep impairment, with higher scores designating poorer sleep and greater impact on daily life.

Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.

Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.

Northern Arizona University

Associate Professor

Pain

Nausea

Vomiting

Signs and Symptoms, Digestive

The first acupressure application will be administered and taught individually by the researcher to the oncology patients in the self-administered group. Afterwards, each patient who learns the application will be asked to apply acupressure on his own for three days. In the self-acupressure group, a questionnaire form consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied first (pre-test) before the acupressure application is taught to the group by the researchers. Afterwards, patients will apply acupressure on their own for three days, and at the end of this period (post-test), a questionnaire consisting of personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied. Acupressure will be applied the large intestine meridian 4th Point (LI4), the pericardium meridian Neiguan (P6) and Yintang (EX-HN3).

In this group, acupressure will be administered to stage I, stage II, and stage III cancer patients receiving at least one course of chemotherapy for a total of three days by researchers with acupressure certification. Before the application (pre-test) by the therapist, a questionnaire consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied to the patients in the group in question. At the end of the three-day acupressure application (post-test) applied to the patients included in the study by the therapist, a questionnaire consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied. In the acupressure group applied by the therapist, a total of three points will be applied to the upper extremity: the 4th point of the large intestine meridian (LI4), the Pericardium Meridian/Neiguan (P6), Yintang (EX-HN3) point.

The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group.

In the self-acupressure group, before the application, the tissue sensitivity will be reduced by heating and rubbing for 20 seconds without direct pressure on the acupressure points, and the points will be made ready for acupressure application. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher for a total of two minutes for each point without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Two of the three different points (LI4 and P6) selected for the application will be applied symmetrically on the other extremity. Therefore, the session duration of each patient will be approximately 12 minutes, depending on the preparation and compression time on each point. Afterwards, acupressure will be applied to themselves by participants

Self-acupressure

In the acupressure group applied by therapist, before the application, the tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher for a total of two minutes for each point without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Two of the three different points (LI4 and P6) selected for the application will be applied symmetrically on the other extremity. Therefore, the session duration of each patient will be approximately 12 minutes, depending on the preparation and compression time on each point.

Acupressure by therapists

No intervention will be made in the control group.

Control group

Esra Çavuşoğlu, Doctorate

Hilal Altundal Duru, Doctorate

Kadir Eser

Emel Sezer

Vehbi Erçolak

Ümmügülsüm Kılıç

The goal of this clinical trial is to compare the effect of self acupressure and acupressure applied by therapists on pain, nausea-vomiting, and mental well-being in oncology patients.

For this purpose, 93 individuals with stage 1-stage 3 cancer will be included in the study.

The main questions it aims to answer are:

• Is acupressure effective on pain, nausea-vomiting and mental well-being in oncology patients? Is there a difference in the effectiveness of self-acupressure and acupressure applied by therapist on pain, nausea-vomiting and mental well-being? The participants will be included in the study as three groups, namely the self-acupressure group, the acupressure group applied by the therapist, and the control group.

Self-acupressure participants will self-administer acupressure. In the acupressure group, which will be applied by the therapist, acupressure will be applied to the participants by researchers who have acupressure certificate.

In the control group, acupressure etc. No additional application will be made. Visual analog scale, nausea-vomiting and retching index, and mental well-being scales will be applied to all groups at the beginning of the study and three days after the study.

Large Intestine Meridian 4th point (Hegu/LI4), Pericardium Meridian/Neiguan (P6) point and Yintang (EX-HN 3) point will be used for acupressure application in the research.

This is a prospective, three-armed (1:1:1), randomized controlled experimental single-blind clinical trial.

Patients included in the study will not be blinded as they will be in acupressure (administered by the therapist), self-acupressure or control groups.

Researchers will be blinded only during group assignment. The data will be transferred to the computer environment by the researchers, and a biostatistician independent of the research will analyze the data and report the findings without knowing which of the three groups are. Thus, the biostatistician will be blinded.

The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients

The Effect of Self-Administered Acupressure and Acupressure Applied by Therapist on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients: A Three-Arm Randomized Controlled Study

The patient evaluates their own pain using a scale ranging from 1 to 10, with 1 = very mild discomfort and 10 = the most severe pain the patient can imagine. Ranges for pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain.

Each response is scored as 0 = least distress, 4 = most distress. The patient's experience of nausea and vomiting in each of the 8 items is summed up. The highest possible value is 32, indicating the most severe symptom occurrence score.

The scale is in the 5-point Likert type and a minimum of 14 and a maximum of 70 points are obtained from the scale. Scoring of the scale is (1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Resilience and Quality of Life Among Cancer Survivors	NCT03466762	Mental Health W...	Non applicable	18 Years -	Aga Khan University
Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite	NCT03488745	Mental Health W... Depression Anxiety	IntelliCare + P...	18 Years -	University of Virginia
A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer	NCT03430141	Chronic Disease Cancer Cardiovascular ... Diabetes Mellit... Lifestyle-relat... Mental Health W... Sleep Nutritional and... Nutrition Relat... Nutritional Imb... Thyroid	Nutritarian Die...	18 Years -	Northern Arizona University
The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients	NCT05898880	Pain Nausea With Vom... Mental Health W...	Self-acupressur... Acupressure by ... Control group	18 Years -	Mersin University
Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite	NCT03488745	Mental Health W... Depression Anxiety	IntelliCare + P...	18 Years -	University of Virginia
The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients	NCT05898880	Pain Nausea With Vom... Mental Health W...	Self-acupressur... Acupressure by ... Control group	18 Years -	Mersin University
Resilience and Quality of Life Among Cancer Survivors	NCT03466762	Mental Health W...	Non applicable	18 Years -	Aga Khan University

Spots Global Cancer Trial Database for mental health wellness 1