Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Infections

Rare Diseases

Necrosis

Arthritis

Arthritis, Psoriatic

Joint Diseases

Spondylarthropathies

Spondylitis

Spondylarthritis

Spinal Diseases

Bone Diseases

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Spondylarthropathy

Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.

Mahmut Gücük, MD

This post marketing observational study is designed to provide the initial data on work impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.

To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)

To Observe the Impacts of Anti-TNF's Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis

Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +\[1- Absenteeism(%)\*Presenteeism(%)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).

A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met:

* ≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count;
* ≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and
* ≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters:

  * Physician's global assessment of disease activity
  * Participant's global assessment of disease activity
  * Participant's assessment of pain
  * HAQ-DI
  * Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein).

The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below:

* DAS28 \> 5.1 = High disease activity
* DAS28 \< 3.2 = Low disease activity
* DAS28 \< 2.6 = Remission

For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13.

A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain).

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.

ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.

CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.

A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).

A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).

A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).

A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor).

A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator.

AbbVie

SAEs were collected and reported; per protocol, non-serious AE data was not collected for this observational study.

Participants Receiving Anti-TNF for PsA

Age, Continuous

Sex: Female, Male

Global Medical Services

Baseline

Month 3

Month 6

Month 9

Participants with an assessment at given time point.

Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9

WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9

WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9

WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9

Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9

ACR20 Responder = No

ACR20 Responder = Yes

ACR50 Responder = No

ACR50 Responder = Yes

ACR70 Responder = No

ACR70 Responder = Yes

Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9

Disease Activity Score (DAS 28) Up to Month 9

Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9

Dactylitis Score Up to Month 9

Number of Swollen Joints Up to Month 9

Number of Tender Joints Up to Month 9

Since sufficient data could not be collected, this analysis was not performed.

Levels of Rheumatoid Factor

Erythrocyte Sedimentation Rate (ESR) Up to Month 9

C-reactive Protein (CRP) Up to Month 9

Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9

Physician's Global Assessment of Disease Activity VAS Up to Month 9

Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9

Participant's Assessment of Total Back Pain VAS Up to Month 9

Participant's Assessment of Pain and Fatigue VAS Up to Month 9

Any SAE

Discontinuations

Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9

Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).

Overall Study

Neoplasms

Nervous System Diseases

Behaviors and Mental Disorders

Fatigue

Breast Neoplasms

Parasomnias

Dyssomnias

Breast Diseases

Quality of Life

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

3 times a week, 60 minute sessions for 6 weeks.

Relaxation Program

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

Questionnaires

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Saliva Testing

Lorenzo Cohen, PHD

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.

This is an investigational study. The relaxation programs are being compared for research purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.

Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

During the first visit, you will fill out questionnaires that ask about your sleeping habits, how you have been feeling, and the general quality of your life. This should take about 60-80 minutes.

Every day for the next 7 days, you will fill out a diary about your sleep. You will also wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect data about your physical activity and sleeping habits.

You will also have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) which will last about 10 minutes.

Study Groups:

After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

* Group 1 will take part in one type of relaxation program.
* Group 2 will take part in another type of relaxation program.
* Group 3 will not take part in either program but will complete some of the follow-up procedures. Participants in this group will be given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet.

You will have about a 1 out of 3 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.

Sessions:

Groups 1 and 2:

You will take part in 3 sessions each week for the 6 weeks of radiation therapy, or 4-5 sessions each week for 4 weeks if your radiation therapy lasts only 4 weeks. You can choose any weekday (Monday through Friday). Each session should last about 60 minutes.

The sessions will be taught by an experienced, trained instructor, usually in groups of 2-5 participants. The movements are designed to be easy to follow. You will be able to work at your own pace.

Each session will be audio and video recorded. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.

Women in Groups 1 and 2 will be randomized to a maintenance intervention arm or a usual contact arm after the end of radiotherapy. If you are randomized to the maintenance intervention arm you will receive telephone counseling once a month after the end of your radiotherapy. You will also receive booster sessions once every 3 months post-radiotherapy, or at least when you come for your follow-up appointments.

Groups 1 and 2:

During the sessions, you will do simple stretching exercises, specific breathing skills, and guided relaxation. You will be asked to try and practice once a day for 12 months. You will be provided a DVD and an audio CD to help with your practice when you are not at the hospital.

Questionnaires and Study Procedures:

Groups 1 and 2:

Before your first session of the week except for week 1, Groups 1 and 2 will fill out a questionnaire about the relaxation program. This should take about 1-2 minutes.

During the middle of your radiation treatment period, you will have an ECG recorded before and after your classes. Each ECG will last about 10 minutes.

All Groups:

During the middle of your radiation treatment period, you will fill out a questionnaire that asks about any symptoms you may be having. This should take about 15 minutes. You will also have an ECG.

During your last week of radiation therapy, and at 3, 6, and 12 months after your radiation therapy ends, you will fill out a set of questionnaires. The questionnaires will be mostly the same as at your first study visit. This should take about 60-80 minutes. You will also have an ECG at these times.

Questionnaire packets will be mailed to your home by the research staff. After completing the questionnaires, you will return the completed questionnaire packet to the research staff via a pre-paid mailing envelope.

Every day for 7 days in a row, after every time you fill out the questionnaires, you will fill out another sleep diary. During these 7-day periods, you will wear an actigraph watch 24 hours a day to collect the same data as before. Each time, you will mail the actigraph watch back to MD Anderson in postage-paid envelopes that will be provided to you.

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

All participants will be asked not to do any other stretching/relaxation practices during the study.

Saliva Testing:

You will provide 4 saliva samples per day for cortisol testing on the following schedule:

* for 3 days before radiation therapy begins
* for 3 days in the last week of radiation therapy
* for 3 days in a row, 3 months after radiation therapy ended
* for 3 days in a row, 6 months after radiation therapy ended
* for 3 days in a row, 12 months after radiation therapy ended

To provide a saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will then mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Length of Participation:

Your study participation will be over after you fill out the questionnaires 12 months after radiation therapy.

Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Effectiveness of 6-week relaxation intervention evaluated by physical component scale scores during and after treatment, defined as Medical Outcomes Study 36-item short-form survey (SF-36).

National Institutes of Health (NIH)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Hormones

Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone)

Patients with early breast cancer who have completed treatment and are in disease-free survival (i.e. no longer receiving locoregional treatment, chemotherapy or targeted HER2 therapy; patients may still be receiving hormone therapy)

Patients receiving treatment for metastatic breast cancer

Chao-Hsiun Tang, Ph.D

Ching-Hung Lin, Ph.D

Liang-Chih Liu, Ph.D

Ming-Feng Hou, M.D.

Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.

Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.

The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Tw HER2 Positive Breast Cancer Productivity & Utility Study

• Percent work time missed due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked)

• Percent impairment while working due to health: Degree health affected productivity while working/10

• Percent overall work impairment due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked)+\[(1-( hours missed due to health problems/( hours missed due to health problems+ hours actually worked)))x(degree health affected productivity while working/10)\]

• Percent activity impairment due to health: Degree health affected regular activities/10

The descriptive system of EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

The EQ VAS records the respondent's self-rated health on a visual analogue scale.

the FACT-B consists of the following subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), social/family well-being (SWB), and breast cancer-specific concerns (BCS). A total FACT-B score is calculated by summing the subscales. The instrument has a total of 41 items asking respondents to rate how true each statement is for the last 7 days. Response scales range from 0 (not at all) to 4 (very much).

age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)	NCT02028169	Psoriatic Arthr... Work Productivi...		18 Years - 90 Years	AbbVie
Relaxation for Women With Breast Cancer Undergoing Radiotherapy	NCT01202851	Breast Cancer	Relaxation Prog... Questionnaires Saliva Testing	18 Years -	M.D. Anderson Cancer Center
Tw HER2 Positive Breast Cancer Productivity & Utility Study	NCT04011085	HER2-positive B...		18 Years -	Taiwan Epidemiology Association

Spots Global Cancer Trial Database for work productivity