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NCT Number: NCT07351461

Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

Prostate cancer (PCa) is the most common cancer and the third leading cause of cancer-related death among men in France.

Active surveillance is one of the management options for low-risk prostate cancer. Its aim is to delay or avoid radical treatment, such as surgery or radiotherapy, which can cause side effects including urinary incontinence, erectile dysfunction, or radiation-induced cystitis. Active surveillance involves regular monitoring of potential tumor progression through serum PSA testing, MRI scans, and prostate biopsies.

Few studies have investigated the psychological adjustment of patients undergoing active surveillance for prostate cancer, and even fewer have explored the relationship between the patients' anxiety symptoms and those of their partners. To our knowledge, no study has yet quantitatively or qualitatively assessed the anxiety of both patients and their partners. It appears essential to better characterize the anxiety symptoms in these individuals in order to offer them appropriate psychological support.

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Key information

Conditions

Prostate Cancer Anxiety Disorders Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years.
  • Patients who started active surveillance for localized prostate cancer from 2007 to 2023 and are followed in the Urology Department of Lille University Hospital.
  • Affiliation to a social security scheme.
  • Obtaining patient consent.
  • Having a life partner or an unidentified partner recognized as the person sharing the patient's daily life

Exclusion criteria

  • Lack of proficiency in the French language.
  • Minor patients, those under legal protection measures, or deprived of liberty.
  • Lack of medical insurance coverage.
  • Patients refusing to participate in the study.

Treatment and study plan

Patient on active surveillance

Other
  • First, a quantitative cross-sectional study of patients on active surveillance at Lille University Hospital, which will aim to determine the prevalence of anxiety disorders in patients and, if possible, in their partners.
  • Then, a qualitative study to explore the potential causes of this anxiety.

Primary outcomes

  1. Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer.

    Time frame: 12 months

    Total score of the 'Memorial Anxiety Scale for Prostate Cancer' questionnaire, whose French translation has been validated (Touzani et al., 2019). Patients scoring >27/54 are classified as anxious.

Secondary outcomes

  1. Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer

    Time frame: 12 months

    Questionnaire assessing anxiety (STAI-Y questionnaire).

  2. To determine the clinical predictive factors of anxiety in patients on active surveillance.

    Time frame: 12 months

    Use of questionnaires assessing general anxiety (STAI-Y questionnaire) in patients and their partners.

  3. To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.

    Time frame: 12 months

    Assessment of intra- and interpersonal emotional skills.

  4. To identify the potential causes of anxiety.

    Time frame: 12 months

    Participants scoring between 115 and 145 on the DCI are considered within the normal range. A score below 115 indicates that participants use dyadic coping strategies less frequently than average. A score above 145 indicates that participants use dyadic coping strategies more frequently than average.

  5. Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.

    Time frame: 12 months

    Assessment of intra- and interpersonal emotional skills.

  6. Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate

    Time frame: 12 months

    Questionnaire assessing the management of emotions (S-PEC questionnaire).

  7. Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate

    Time frame: 12 months

    Questionnaire assessing the stress (Dyadic coping inventory questionnaire).

  8. To determine the clinical predictive factors of anxiety in patients on active surveillance.

    Time frame: 12 months

    Use of questionnaires assessing the stress (Dyadic coping inventory questionnaire) in patients and their partners.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan OLIVIER, Dr

CONTACT

[email protected]

0320444398

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Official study title

Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

Acronym: ANCAPRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 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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