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Completed

NCT Number: NCT01606033

Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating

This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

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Key information

Conditions

Metastatic Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrent Hematologic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oscar Lambret Center, Lille, Hauts-de-France, France

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About this study

This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)
  • subject to a 1st, 2nd or 3rd line of antitumor treatment
  • a phase 2 open labeled study,
  • a phase 2 or 3 blind randomised study,
  • a phase 2 or 3 open randomised study,
  • a standard treatment non participating to a clinical trial
  • male or female patients ≥ 18 years of age
  • karnovsky ≥ 70 % or WHO (Performance Status) ≤ 2
  • recovered from prior toxicities
  • social security covered
  • written informed consent given

Exclusion criteria

  • psychiatric disorders, receiving psychotropic treatment
  • physical or psychological issues
  • forbidden to be included in this study

Treatment and study plan

questionnaires

Other

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

Questionnaire

Other

understanding of the implications of participating in a clinical trial

Primary outcomes

  1. assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way

    Time frame: 4 years

    quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)

Secondary outcomes

  1. evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation

    Time frame: 4 years

    adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)

  2. measure and compare variation in time of psychological and emotional consequences during treatment

    Time frame: 5 years

    emotional regulation (DERS 24)

  3. measure the level of knowledge on the implications of participating in a clinical trial (case)

    Time frame: 5 years

    assess impact of it on psychological and emotional experience

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

Acronym: IPSY

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 25, 2012
Registry last updated
Mar 13, 2026

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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