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Completed

NCT Number: NCT03951701

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care Needs

Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.

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Key information

Conditions

Supportive Care Needs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Paul Strauss

Strasbourg, 67065, France

About this study

The study will unfold in the followed day hospital's departments of the Paul Strauss Cancer Center (Strasbourg, France) : supportive care department, chemiotherapy department and radiotherapy department. The study is based on two questionnaires that include six sections : nutrition, social, psychologic, physiotherapy, pain and supportive care needs evaluation.

The first questionnaire gives information about the patient and allow to screen supportive care needs. It should be read by medical or paramedical staff who report the function of the reader and options that are proposed to the patient after reading the questionnaire.

The second questionnaire will be done after 4 to 6 weeks by a phone call from the clinical research nurse. The objective of this questionnaire is to determine what kind of care have been provided.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient treated for a cancer
  • Age ≥ 18 years old
  • Receiving treatment (chemotherapy and/or radiotherapy) in day hospital and/or supportive care department
  • Able to speak, read and understand French
  • Able to communicate by phone
  • Written informed consent obtained from the patient
  • Registration in a national health care system

Exclusion criteria

  • Minor or protected adult
  • Pregnant or breastfeeding woman

Treatment and study plan

Evaluation of the supportive care

Other

Evaluation of interest of a systematic screening for oncological supportive care needs

Primary outcomes

  1. Evaluation of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional of health, by a phone call

    Time frame: 4 to 6 weeks after baseline

    Assess the percentage of using oncological supportive cares after evaluation of supportive care needs reviewed by a professional. The use of supportive cares is evaluated with an hetero-questionnaire created for this study. The hetero-questionnaire consists in a phone call to evaluate the evolution of each item of the self-assessment questionnaire (which includes 6 evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items)).

Secondary outcomes

  1. Evaluation of initial supportive care needs by the self-assessment questionnaire

    Time frame: baseline

    Assess the percentage of initial supportive care needs evaluated by the self-assessment questionnaire created for this study. It includes evaluations : a nutritional evaluation (10 items), a social evaluation (8 items), a psychologic evaluation (6 items), a physiological evaluation (7 items), a pain evaluation (4 items) and a supportive care needs evaluation (6 items).

  2. Assess the correlation between supportive care needs and age

    Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)

    Correlate the percentage of supportive care needs to age by a Pearson Chi squared test

  3. Assess the correlation between supportive care needs and sexe

    Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)

    Correlate the percentage of supportive care needs to sexe by a Pearson Chi squared test.

  4. Assess the correlation between supportive care needs and type of cancer

    Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)

    Correlate the percentage of supportive care needs to the type of cancer by a Pearson Chi squared test

  5. Compare the percentage of using a supportive care professional judgement in regard to read and unread questionnaires by medical staff

    Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)

    Assess the percentage of using a supportive care when the medical staff read the completed questionnaire. Assess the percentage of using a supportive care when the medical staff didn't read the completed questionnaire. Then compare these values by using a T- test of Student.

  6. Compare the percentage of using a supportive care professional judgement in regard to the function of the medical staff member

    Time frame: This analyse will be realized at the end of the study (9 weeks after baseline)

    Assess the percentage of using a supportive care when the medical staff who read the completed questionnaire is a doctor, a nurse, or an auxiliary nurse . Then compare these values by using a T- test of Student

  7. Assess the percentage of requirement to the physician during the study

    Time frame: 4 to 6 weeks after baseline (by a phone call, at the same time than the hetero-questionnaire)

    Assess the percentage of requirement to the physician during the study by asking each patient (by phone call)

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study title

Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

Acronym: DBSOS

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 15, 2019
Registry last updated
May 23, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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