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NCT Number: NCT03307200

Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Surgery Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Cancer Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University, Ghent, Belgium

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age is 18 years or older
  • Patients diagnosed with bladder cancer who will undergo radical cystectomy
  • Patient has to be able to sign informed consent

Exclusion criteria

  • Metastatic cancer
  • Presence of a second primary tumor with the exception of fully deleted prostate cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control

Treatment and study plan

Primary outcomes

  1. Change in Unmet supportive care needs

    Time frame: From baseline up to 1 year

    Assessed with the 34-item supportive care needs survey (SCNS-34)

Secondary outcomes

  1. Change in Cancer-specific Health-related quality of life

    Time frame: From baseline up to 1 year

    Assessed with the EORTC-qlq-c30

  2. Change in Bladder cancer-specific Health-related quality of life

    Time frame: From baseline up to 1 year

    Assessed with the EORTC-qlq-blm30

  3. Change in Psychological distress

    Time frame: From baseline up to 1 year

    Assessed with the distress thermometer

  4. Change in problems associated with psychological distress

    Time frame: From baseline up to 1 year

    Assessed with the problem list

  5. Health literacy

    Time frame: Baseline

    Assessed with the BRIEF Health Literacy Screening Tool

  6. Change in Physical activity pattern

    Time frame: From baseline up to 1 year

    Assessed with the Godin Leisure-Time Exercise Questionnaire

  7. Change in Physical Activity Stage of change

    Time frame: From baseline up to 1 year

    Assessed with a questionnaire based on an algorithm made by Marcus et al.

  8. Change in The use of health care services

    Time frame: From baseline up to 1 year

    Separate questions where the patient is asked about his/her use of supportive health care services.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 11, 2017
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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