Long Term Cancer Side EffectsAFTERGYNNCT05731661
Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
A study testing Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse, Delivery of useful information according to support care needs, concerning support care professionals in the city and Delivery of a personalized post-cancer plan in people with Long Term Cancer Side Effects and Supportive Care in Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Long Term Cancer Side Effects, Supportive Care in Cancer, Cancer Survivorship Care Plan
- What is being tested?
- Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse, Delivery of useful information according to support care needs, concerning support care professionals in the city and Delivery of a personalized post-cancer plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 25 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Long Term Cancer Side Effects, Supportive Care in Cancer, Cancer Survivorship Care Plan, Advanced Nurse Practitioner, Pelvic Gynecological Cancer
- Being tested
- Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse, Delivery of useful information according to support care needs, concerning support care professionals in the city, Delivery of a personalized post-cancer plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurseOther
During this day hospitalization, patients will meet with different specialized professionals depending on the support care needs identified.
Delivery of useful information according to support care needs, concerning support care professionals in the cityOther
Delivery of useful information according to support care needs, concerning support care professionals in the city
Delivery of a personalized post-cancer planOther
Delivery of a personalized post-cancer plan
| Study group | Role | What they receive |
|---|---|---|
| Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care | Experimental | Not described Receives: Other: Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse; Other: Delivery of a personalized post-cancer plan |
| Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care | Active comparator | Not described Receives: Other: Delivery of useful information according to support care needs, concerning support care professionals in the city; Other: Delivery of a personalized post-cancer plan |
| Observational cohort | Other | Not described Receives: Other: Delivery of a personalized post-cancer plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 4 months
Secondary outcomes (3)
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
Measured: Up to 4 months
Description of the types of oncological support care needs identified
Measured: Up to 4 months
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
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start9 Jan 2023
- Primary completion20 Nov 2025
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Cancer Side EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731661
- Sponsor's protocol ID
- 2022-A01872-41
- Acronym
- AFTERGYN
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
- ClinicalTrials.gov ID
- NCT05731661
- Acronym / sponsor ID
- AFTERGYN / 2022-A01872-41
- Conditions
- Long Term Cancer Side Effects, Supportive Care in Cancer, Cancer Survivorship Care Plan, Advanced Nurse Practitioner, Pelvic Gynecological Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care | Experimental | Other: Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse, Other: Delivery of a personalized post-cancer plan |
| Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care | Active comparator | Other: Delivery of useful information according to support care needs, concerning support care professionals in the city, Other: Delivery of a personalized post-cancer plan |
| Observational cohort | Other | Other: Delivery of a personalized post-cancer plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurseDuring this day hospitalization, patients will meet with different specialized professionals depending on the support care needs identified. | Other | Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care |
| Delivery of useful information according to support care needs, concerning support care professionals in the cityDelivery of useful information according to support care needs, concerning support care professionals in the city | Other | Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care |
| Delivery of a personalized post-cancer planDelivery of a personalized post-cancer plan | Other | Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care, Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care, Observational cohort |
Primary outcome
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
Time frame: Up to 4 months
3 secondary outcomes
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
Time frame: Up to 4 months
Description of the types of oncological support care needs identified
Time frame: Up to 4 months
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
Time frame: Up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse, Delivery of useful information according to support care needs, concerning support care professionals in the city and Delivery of a personalized post-cancer plan in people with Long Term Cancer Side Effects and Supportive Care in Cancer, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.