Psychological Experience of Discontinuation an Early Phase Treatment by Patients

NCT03905876 | Completed DMC

• 1 other identifier: 2018-A02330-55
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).

Conditions

Psychological Distress; Cancer

Keywords

Psychological experience; early clinical trial; initial predisposition

Outcome Measures

Primary Outcomes (1)

• Score of anxiety and depression at the end of treatement in an early clinical phase by using the scale HADS (hospital anxiety and depression scale). The range is 0 to 21. The severe anxiety or depression is 21.

  Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase

  Approximatey 36 months

Secondary Outcomes (9)

• Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.

  Day 1 and approximately 36 months

• Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.

  Day 1 and approximately 36 months

• Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory)

  Day 1 and approximately 36 months

• Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40.

  Day 1

• Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40.

  Day 1

Study Arms (1)

assessment of psychological experience

OTHER

Questionnaire

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaire to evaluate psychological experience

assessment of psychological experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven solid cancer locally advanced or metastatic in treatment failure with standard treatments
• Antitumor therapy in an early phase clinical trial
• Comprehension in French sufficient for a good completion of the questionnaires
• Informed consent signed before any specific procedure to study
• Belong to a French social security scheme or equivalent scheme
• Age ≥ 18 years

You may not qualify if:

• Score \<15 on the Montreal Cognitive Assessment (MoCA) test assessing overall cognitive functioning
• Presence of proven psychiatric disorders (eg, mental retardation, psychotic disorders, learning disabilities, attention deficit / hyperactivity disorder, bipolar disorder ...), excluding reactional mood disorders to the experience of the disease, or receiving treatment psychotropic disorder that ability of reasoning, judgment or understanding
• Possibility of benefiting from standard therapeutic options
• Included in an exclusive clinical trial or for which the sponsor has refused to that his trial are associate to the study "VRAIMENT"
• Physical inability to answer questionnaires
• Legal incapacity or limited legal capacity

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (8)

• Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22.

  PMID: 21098322 BACKGROUND

• Bredart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X. Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12.

  PMID: 27734561 BACKGROUND

• Kroenke K, Johns SA, Theobald D, Wu J, Tu W. Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer. 2013 Mar;21(3):765-73. doi: 10.1007/s00520-012-1578-5. Epub 2012 Sep 1.

  PMID: 22941116 BACKGROUND

• Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011 Jul;47(10):1490-7. doi: 10.1016/j.ejca.2011.02.020. Epub 2011 Mar 30.

  PMID: 21454072 BACKGROUND

• Balbuena L, Bowen R, Baetz M, Marwaha S. Mood Instability and Irritability as Core Symptoms of Major Depression: An Exploration Using Rasch Analysis. Front Psychiatry. 2016 Oct 26;7:174. doi: 10.3389/fpsyt.2016.00174. eCollection 2016.

  PMID: 27833568 BACKGROUND

• Tian J, Hong JS. Assessment of the relationship between resilience and quality of life in patients with digestive cancer. World J Gastroenterol. 2014 Dec 28;20(48):18439-44. doi: 10.3748/wjg.v20.i48.18439.

  PMID: 25561814 BACKGROUND

• Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.

  PMID: 27124466 BACKGROUND

• Bozo O, Gundogdu E, Buyukasik-Colak C. The moderating role of different sources of perceived social support on the dispositional optimism-- posttraumatic growth relationship in postoperative breast cancer patients. J Health Psychol. 2009 Oct;14(7):1009-20. doi: 10.1177/1359105309342295.

  PMID: 19786527 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• jean Pierre BLEUSE, Dr

  Insititut régional de Cancer de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: April 5, 2019
• Study Start: January 21, 2019
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: February 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)