Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Depressive Disorder

Recurrence

Depression

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Yeur-Hur Lai, Ph. D.

The lung cancer is the most has the life minacity in all kinds of cancers, and it also remains the most common cause of cancer-related death in the world. The group of lung cancer patients are suffer from huge disease impact that came from high mortality. Not only the course of treatment that patients has been diagnosis through operation is more faster, but also those who could be capable of operated are stabilized to keep follow-up at out-patient clinic. But in the next following five years after operation, they may take different dysfunctional level or some kinds of symptom distress. The effect has a great influence on those patients that have to face extended emotional impact, symptom distress and life style change. In addition, most of them concern about recurrent all the time in the remission. These situation needs us to place importance on it.

The purposes of this study are to investigate psychological and physical distress and care needs in operable lung cancer patients receiving surgery. This survey includes two parts of physical and mental condition. First, the investigators are scoring their symptom severity and quality of life to check physical condition. Seconded, the mental condition will use validated questionnaires to realize the relationship of anxiety, depression, uncertainty, fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients' needs.

This study is a cross-sectional designs with convenience sampling that conform to the investigators recruited requirements. The investigators will recruit from the clinic of thoracic surgery in one medical center in Taipei and take five structured requirements. And the investigators are going to collect data from January, 2011 to December, 2012. Also expect results are lung cancer outpatients after surgery that more physical dysfunction or more depress of mental condition, it will lead patients' needs increased or significant difference. In conclusion, this study analyzes their needs in the remission that consequences can be medical professionals' reference material.

Inclusion Criteria:

lung cancer patients after surgery stage I, II and IIIA surgery for 3 months to 5 years over 20 years old

Exclusion Criteria:

lung cancer recurrence conscious unclear and do not know having cancer used to be treat (surgery, chemotherapy or radiotherapy) in 3 months. be uncomfortable or cooperate to fill the questionnaire.

Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery

National Taiwan University

National Taiwan University Hospital

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

The experimental group will receive the web-based interactive self-management support intervention.

The control group will receive usual care and regular patients education.

The intervention group will receive a 60-90 minute introduction to the web-based interactive self-management support program. They will be instructed to do the weekly online self-assessment on symptoms, emotion, and health behaviors and how to use the web-based program to manage their health by applying self-manage skills and behavior change techniques. The contents of the interactive colorectal cancer self-management website include the following five main components: Health Support Station, Knowledge Supply Station, Sharing Stories, My Dear Friend, and Asking a Nurse.

Web-based interactive self-management support program

Tsae Jyy Wang, PhD

Ting Ru Lin, MS

Yi-Chiu Li, MSN

Wen Chien Huang, PhD

Shih-Chang Chang, Dr.

Shih Chang Chang

The study aims to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, secondary outcomes, symptom distress, emotional distress, physical activity, and the mediation effects of self-efficacy, and supportive care needs in colorectal cancer patients.

Colorectal cancer is the most commonly diagnosed cancer in Taiwan. With proper treatments, most patients can be long-term survivors. However, patients often suffered long-term consequences of the disease and its treatment side effects. In addition, unhealthy lifestyles will further impact on patient's prognosis and quality of life. Face-to-face or web-based self-management support interventions can help colorectal cancer patients to achieve a healthy lifestyle and better adjustment. However, they are costly and may not be assessable for a certain population. Therefore, it is necessary to develop the most cost-effective interventions for patients with colorectal cancer.

Aim: The study aims is to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, and secondary outcomes, symptom distress, emotional distress, physical activity, nutrition intake, and the mediation effects of self-efficacy, social support, and supportive care needs in colorectal cancer patients.

Design: A multi-center randomized six-month follow-up parallel-group superiority design will be used to test the intervention efficacy. A convenient sample of 160 post-operative colorectal cancer patients (stage I-III) will be recruited and randomized to the control or intervention group. Outcome variables will be assessed on the baseline, 2nd, 4th, and 6th month in both groups.

Instruments: The study instruments include Cancer Behavior Inventory-Brief Version, 34-item Supportive Care Needs Survey, M.D. Anderson Symptom Inventory, The Center for Epidemiologic Studies Depression Scale, International Physical Activity Questionnaire, and FACT-C.

Data analysis: Descriptive analysis will be used to describe patients' demographics, disease variables, and outcome variables. The Chi-square, t-test, and Linear Mixed Model will be used to test the efficacy of the study interventions.

Significance: The study results will provide evidence for the efficacy of the web-based interactive self-management support intervention for enhancing a healthy lifestyle and quality of life in colorectal cancer patients.

The study participants will be randomly assigned 1:1 to the intervention or the control group by the stratified permuted block randomization and block 4, 6, 8 will be used. The randomization will be stratified by cancer stage (stage I-IIA; stage IIB-III). The Sealed Envelope software (Sealed Envelope Ltd., 2016) will be used to generate the random sequences and sealed envelopes will be used to conceal the assignment of each participant.

Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer

Efficacy of an Interactive Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer: A Mixed-methods Study

There are two subscales, 27 items of FACT-General and 9 items of Colorectal Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The possible score for the scale ranges from 0 to 136. The higher values represent better quality of life.

The Taiwan Version of International Physical Activity Questionnaire is used to measure a patient's physical activity. The scale has 7 items, asking patients the time they spent on walking, moderate, and vigorous physical activities during the past 7 days. The amounts of time spent on walking, moderate and vigorous physical activities are then multiplied by 3.3, 4.0, and 8.0 MET, respectively. The sum of the METs-min/wk for three types physically actives is the total score of the scale.

There are 12 questions in total. It measures cancer patients 1) maintain independence and a positive attitude, 2) participate in medical care, (3) respond to and manage stress, and 4) Four aspects of self-efficacy, such as managing emotions. Each question is scored from 1 point "very unconfident" to 9 points "very confident". The total score of each question is the total score of the scale, and the possible range of scores Between 12 and 108 points, the higher the score, the higher the self-efficacy.

34-item Supportive Care Needs Survey (SCNS-SF34) measures the supportive care needs of research subjects. This scale mainly to assess cancer patients' psychological (10 questions), health system and information (11 questions), body and daily life (5 questions), medical care and support ( 5 questions) and sex (3 questions) and other five aspects of support and care needs, each question is scored on a Lick-style scale ranging from 1 point "not necessary" to 5 points "very necessary", and the total score of each question is added. The total score in the table, the possible score ranges from 34 to 170 points, the higher the score, the higher the need for support and care.

MDASI (M.D. Anderson Symptom Inventory) measures the symptom distress and consists of a 13-item symptom scale and a 6-item interference scale. The 13 symptoms were pain, fatigue, nausea, interrupted sleep, depression, shortness of breath, difficulty in remembering, loss of appetite, lethargy, dry mouth, sadness, vomiting, numbness/tingling. The interference scales for 6 questions are interference with walking, mobility, working ability (including housework), relationship with others, enjoying life, and mood. Each question is scored on a Lick-style scale ranging from 0 points "not at all" to 10 points "very bad". The average score of each question is the total score of the scale. The possible score ranges from 0 to 10 points. The higher the score, the more the symptom. The more serious the trouble, the average score of 1 to 4 means mild symptom distress, 5-6 means moderate symptom distress, and 7-10 means severe symptom distress.

Ministry of Science and Technology, Taiwan

Mackay Memorial Hospital

Cathay General Hospital

National Taipei University of Nursing and Health Sciences

Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

Skin and Connective Tissue Diseases

Fatigue

Breast Neoplasms

Breast Diseases

Skin Diseases

1. The surgical pathological tissue report confirms the diagnosis of breast adenocarcinoma women with stage I\~III
2. Those who are admitted to the hospital and receive adjuvant chemotherapy for the first time.
3. Age (inclusive) over 20 years old.

1. The surgical pathological tissue report establishes women diagnosed as stage 0 to stage III breast cancer
2. Those who are admitted to the hospital to receive anti-hormonal drug treatment.
3. Age (inclusive) over 20 years old.

breast adenocarcinoma receiving chemotherapy

Control-for

Tsai-Wei Huang, PhD

When receiving adjuvant chemotherapy, a variety of symptoms will appear and it is very painful. These symptoms occur at the same time and are related to each other. The symptom distress may affect the patient's compliance with adjuvant chemotherapy and whether the adjuvant chemotherapy can be completed on schedule. Among the symptoms of trouble, cancer-related fatigue is the most common, and the incidence can be as high as 99%. In this study, I want to track the population of breast cancer patients receiving adjuvant chemotherapy, and women in the control group who receive only anti-hormonal breast cancer or carcinoma in situ. During the treatment period, at different time points, it also collects subjective symptom distress changes and changes. The study aimed cancer-related exhaustion is measured to gain a deeper understanding of the effects of symptom troubles suffered by patients during treatment. We also hoped that in the future, it can be provided to colleagues in clinical work and can be given to breast cancer patients receiving adjuvant chemotherapy and increased holistic care quality.

Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female

Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female: an Prospective Study

Edmonton Symptom Assessment Scale, ESAS; including nine symptoms, one symptom range from 0-10, total score 0-90.

Brife fatigue inventory, BFI; including nine items, total score 0-10.

Distress Thermometer, DT; range from 0-10.

FACT-B;multidimensional questionnaire with 37 items that build 5 dimensions (subscales) when using a 5-point Likert scale. (from 0, not at all through 4, very much) that constitute 5 dimensions.

PHQ-4;PHQ-4 Scoring: Total score ranges from 0 to 12, with categories of psychological distress as follows:

None: 0-2; Mild: 3-5; Moderate: 6-8; Severe: 9-12; Anxiety subscale = sum of items 1 and 2 (score range: 0 to 6) Depression subscale = sum of items 3 and 4 (score range: 0 to 6) On each subscale, a score of 3 or greater is considered positive for screening purposes.

(ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.11,24 The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Taipei Medical University

School of Nursing

Patients with advanced cancer receiving palliative care.

Primary caregivers of Patients with advanced cancer receiving palliative care.

Nine questionnaires taking about 40 minutes to complete.

Questionnaires

Eduardo Bruera, MD

Primary Objective:

-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.

Secondary Objectives:

* To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
* To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
* To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
* To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).

Questionnaires:

If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.

The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.

The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)

The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.

Length of Study Participation:

After completing the questionnaires, your participation in this study will be over.

This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Spirituality/Religiosity in Patients and Caregivers

A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Services from a Nurse Navigator

Kristine Kwekkeboom, PhD, RN

Sandra E Ward, PhD, RN

There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued by cancer patients, but no studies have evaluated the effects of CNNs on important patient-reported outcomes or indicators of quality of care. This study has two aims:

1. To assess the feasibility of studying the impact of Aurora CNN Program.
2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.

Effect of Cancer Nurse Navigators on Patient Outcomes

Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes

The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.

The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.

The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.

This instrument measures 30 cancer-related irritants (hassles) commonly experienced by persons with cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery	NCT01362842	Anxiety Postope... Patient Non-Com... Psychological D...		20 Years -	National Taiwan University Hospital
Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer	NCT05045976	Colorectal Neop...	Web-based inter...	20 Years - 75 Years	National Taipei University of Nursing and Health Sciences
Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female	NCT04911699	Symptom Distres...	breast adenocar... Control-for	20 Years -	Taipei Medical University
Spirituality/Religiosity in Patients and Caregivers	NCT00634257	Advanced Cancer Solid Tumors	Questionnaires	18 Years -	M.D. Anderson Cancer Center
Effect of Cancer Nurse Navigators on Patient Outcomes	NCT01902823	Lung Cancer Breast Cancer Colorectal Canc... Prostate Cancer	Services from a...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for symptom distress