Quality of Life, Unmet Needs & Satisfaction With Care After Vulvar Cancer

Status Active, not recruiting

Clinical Trial Summary

The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.

Clinical Trial Description

PRIMARY OBJECTIVES: Information about: - General and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer - Treatment-related morbidity after any treatment for newly diagnosed vulvar cancer - Unmet needs of patients with newly diagnosed vulvar cancer - Satisfaction with care after any treatment for newly diagnosed vulvar cancer in Sweden. OUTLINE: The study is planned as a prospective, longitudinal multi-centre study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm. 150 patients are estimated for inclusion during a time frame of about 18 months. Eligible patients will be asked to complete a validated questionnaire at different points of time (before and after treatment). Calculating a response rate of about 50% - 60%, this will result in at least 80 completed questionnaires. The questionnaires consist of the following parts: - European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30 - European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-VU-34 (Vulva-specific module) - Hospital Depression and Anxiety Scale (HADS) - Supportive Care Needs Survey Short Form, excerpt (SCNS-SF34) - European Organisation for Research and Treatment of Cancer (EORTC)-PATSAT (Patient Satisfaction), excerpt - Demographic data - 25 self-constructed (and validated) questions RESULTS: Results are expected to be available in 2021. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04152512
Study type	Observational
Source	Karolinska University Hospital
Contact
Status	Active, not recruiting
Phase
Start date	August 29, 2019
Completion date	October 2027

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT06238557` - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT05472935` - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers	N/A
Recruiting	`NCT04444544` - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed	`NCT04281953` - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting	`NCT05546931` - Mobile Health Program for Rural Hypertension	N/A
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Recruiting	`NCT04142827` - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)	N/A
Active, not recruiting	`NCT05903638` - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Completed	`NCT06216015` - Exercise Training and Kidney Transplantation	N/A
Completed	`NCT03813420` - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level	N/A
Recruiting	`NCT05550545` - Infant RSV Infections and Health-related Quality of Life of Families
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Recruiting	`NCT05233020` - Robotic Versus Hybrid Assisted Ventral Hernia Repair	N/A
Terminated	`NCT03304184` - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life	Phase 3
Completed	`NCT05063305` - Probiotics, Immunity, Stress, and QofL	N/A
Recruiting	`NCT05380856` - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer — PROVE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms