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NCT Number: NCT06517355

Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners

Single-centre prospective pilot study designed to demonstrate the acceptability of onco-sexology management for laryngectomy patients and their partners in order to improve their perception of their intimate life. This is a non-interventional study (category 3 Loi Jardé), which will not result in any change in patient management. All procedures will be carried out in accordance with standard practice.

Patients will be followed for 14 months.

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Key information

Conditions

ORL Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For patients:

  • Patient to be treated for ORL cancer by total (pharyngo)laryngectomy
  • Patient WHO 0-1-2
  • Age greater than or equal to 18 years
  • Patient who has not objected to participation in the study.

For partners (if applicable) :

  • Age greater than or equal to 18 years
  • Subject who has not objected to participation in the study.

Exclusion criteria

For patients:

  • Patient with another co-existing malignant disease at the time of inclusion.
  • Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
  • Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

For partners (if applicable):

  • Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

Treatment and study plan

In this research, the procedure under study is represented:

Other
  • On the one hand, by carrying out sexology consultations which consist of individual interviews with a qualified sexologist nurse.
  • Secondly, questionnaires to assess quality of life and sexual function, to be completed by patients during standard follow-up consultations; and a questionnaire on satisfaction with sexological follow-up, to be completed by patients and their partners (if applicable) during the last standard follow-up consultation.

Primary outcomes

  1. The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.

    Time frame: 14 months for each patient

    This rate corresponds to the ratio of the number of patients meeting the acceptability criteria to the total number of patients included.

    Acceptability is defined when the following two criteria are validated:

    • Completion of onco-sexology consultations 2 and 3 (at 3 and 12 months after cancer treatment)
    • Patient satisfaction ≥ 3 on a numerical scale from 1 to 5.

Secondary outcomes

  1. For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.

    Time frame: 14 months for each patient

    The score, which ranges from 0 to 100, is determined according to the algorithm published by the EORTC, based on answers to 8 questions. This is a self-administered questionnaire validated in French

  2. For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.

    Time frame: 14 months for each patient

    These are self-administered questionnaires validated in French.

  3. For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).

    Time frame: 14 months for each patient

    The FSFI (Female Sexual Function Index) is a self-administered questionnaire validated in French. It comprises 19 items studying 6 dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm) which make up an overall score of between 2 and 36.

  4. For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).

    Time frame: 14 months for each patient

    The MSHQ (Male Sexual Health Questionnaire) is a self-questionnaire validated in French which assesses the ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).

  5. For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.

    Time frame: 14 months for each patient

    It will be assessed using a descriptive analysis (marital status before and after cancer treatment, stability, strengthening or deterioration of the couple's relationship).

  6. For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.

    Time frame: 14 months for each patient

    It will be assessed using a Likert scale. This type of scale was developed to measure attitudes and opinions (Rensis Likert 'A Technique for the Measurement of Attitudes', Archives of Psychology, vol.140, 1932, p. 1-55).

  7. For the partner: - The rate of partners verifying the acceptability criteria for onco-sexology management is defined by the ratio of the number of partners verifying the acceptability criteria to the total number of partners included.

    Time frame: 14 months for each partner

    The definition of acceptability is the same as for the primary endpoint.

  8. For the partner: The impact of the (pharyngo)laryngectomy totale on the couple's relationship will be assessed using a descriptive analysis (stability, reinforcement or deterioration of the couple's life).

    Time frame: 14 months for each partner

  9. For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.

    Time frame: 14 months for each partner

Study contacts

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

Julienne VIDAL

CONTACT

[email protected]

05 31 15 51 36

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: ABSENS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2024
Registry last updated
Jun 16, 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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