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Quality of Life clinical trials

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NCT ID: NCT03503435 Withdrawn - Quality of Life Clinical Trials

The Effect of Art Therapy on Total Laryngectomy Patients

Start date: July 2019
Phase: N/A
Study type: Interventional

Total laryngectomy (TL) patients suffer from a myriad of psychological and physiological difficulties following surgery. One of their main difficulties in communication due to problems in speaking. Art therapy offers an alternative means of communication via visual art making and has been shown to reduce psychological distress in cancer patients. Thus the goal of our study is to examine the effect of participating in a group art therapy session on the psychological and physical well being of TL patients. Our design is a quasi-experimental qualitative study with a pre-post design, collecting data with validated questionnaires and self-reports of the participants.

NCT ID: NCT03257332 Withdrawn - Quality of Life Clinical Trials

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

EDFI-Cohort
Start date: November 12, 2019
Phase:
Study type: Observational [Patient Registry]

Background: Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer. Purpose: The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment. Methods: We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients. Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME). Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity. We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

NCT ID: NCT03185780 Withdrawn - Quality of Life Clinical Trials

Complementary/Integrative Medicine for Brain Cancer Patients

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. The most common malignant tumor of the brain is the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. Complementary medicine treatments such as acupuncture and touch therapies (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens. The present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for HGG. The study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.

NCT ID: NCT03094442 Withdrawn - Quality of Life Clinical Trials

Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Start date: December 2016
Phase: N/A
Study type: Interventional

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

NCT ID: NCT02984033 Withdrawn - Quality of Life Clinical Trials

Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer

Start date: November 2016
Phase:
Study type: Observational

The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

NCT ID: NCT02961686 Withdrawn - Quality of Life Clinical Trials

Quality of Life and Sexuality in Patients With Prostate Cancer

Start date: July 16, 2019
Phase:
Study type: Observational

The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

NCT ID: NCT02872506 Withdrawn - Quality of Life Clinical Trials

Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection

CASINO
Start date: September 2017
Phase: N/A
Study type: Interventional

Compare the quality of life at 6 months between 2 populations of patients followed for terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.

NCT ID: NCT02861170 Withdrawn - Quality of Life Clinical Trials

Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability

CALM
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty. All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.

NCT ID: NCT02809703 Withdrawn - Quality of Life Clinical Trials

Quality of Life Following ECMO

Start date: August 28, 2017
Phase:
Study type: Observational

The objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ECMO). The study population will include all adults treated with any configuration of ECMO at Duke University Medical Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality of life. In addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their ICU experience and answer specific questions regarding long-term comorbidities. Data will be stored in a secure online server which is HIPAA compliant and analyzed by the department of anesthesiology statistical support services. De-identified data will be shared with the WHO as specified in their usage agreement.

NCT ID: NCT02311465 Withdrawn - Quality of Life Clinical Trials

A Randomized Study of Early Palliative Care

Start date: December 2015
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.