Clinical trial NCT05731661: Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
Official title: Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Term Cancer Side Effects
Supportive Care in Cancer
Cancer Survivorship Care Plan
Advanced Nurse Practitioner
Pelvic Gynecological Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2023-02-16
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: While the sequelae and toxicities after ovarian and endometrial cancer treatments are well described in the literature, the actual needs of patients for supportive oncology care remain poorly documented. Moreover, there is no data available to estimate the complexity of the oncological support care actions to be implemented.

It is expected that an evaluation of the needs for supportive oncology care and its organization in day hospitalization for supportive oncology care will lead to an improvement in personalized post-cancer follow-up for these patients and to an improvement in their long-term quality of life.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Patient in complete remission after first-line treatment for endometrial or ovarian/fallopian tube/peritoneal cancer
* Patient having completed her initial treatment; patients with maintenance treatments are eligible
* Mastery of the French language
* Patient with a telephone line
* Patient affiliated to a social security scheme
* Signature of informed consent before any specific procedure related to the study

Exclusion Criteria:

* Any associated medical or psychiatric conditions that could compromise the patient's ability to participate in the study
* Patient with locoregional or metastatic recurrence
* Patient deprived of liberty, under guardianship or curatorship
* Simultaneous participation in a therapeutic clinical trial

Primary outcomes:
measure: Proportion of patients who used at least one of the oncology support services recommended in the Personalized After-Cancer Care Plan within 4 months of receiving the Personalized After-Cancer Care Plan
timeFrame: Up to 4 months
Secondary outcomes:
measure: Proportion of patients with sequelae after the initial treatment of their cancer, as well as the type and grade of the sequelae, based on the National Cancer Institute's screening grids (levels 1 and 2) during the consultation with a nurse referent
timeFrame: Up to 4 months
measure: Description of the types of oncological support care needs identified
timeFrame: Up to 4 months
measure: Proportion of patients with identified cancer care needs (at least one cancer care need to be implemented) 4 months after the submission of the Personalized Cancer Care Plan
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
Study officials:
References: