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New treatment option for Ovarian Cancer
Official title PROADAPT-ovary/EWOC-2
ClinicalTrials.gov ID: NCT04284969
What this study is testing
- What it's testing
- PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of published data (Figure). It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older, women only
You may be able to join if
- Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6);
- Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or...
- Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
- Therapeutic decision validated in a multidisciplinary consultation meeting
- Life expectancy \> 3 months.
You likely can't join if
- Any other progressive malignant tumor interfering with the patient's prognosis.
- Patient whose validated therapeutic management does not include cytoreductive surgery.
- Patient unable to be regularly followed up for any reason (geographic, family, social, psychological).
- Patient unable to understand the questionnaires.
- Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
See the full eligibility criteria
- Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6);
- Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if...
- Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
- Therapeutic decision validated in a multidisciplinary consultation meeting
- Life expectancy \> 3 months.
- Written informed consent obtained.
- Covered by a Health System where applicable.
- Any other progressive malignant tumor interfering with the patient's prognosis.
- Patient whose validated therapeutic management does not include cytoreductive surgery.
- Patient unable to be regularly followed up for any reason (geographic, family, social, psychological).
- Patient unable to understand the questionnaires.
- Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient deprived of liberty.
- Concurrent participation in another treatment drug trial.
- Patient already included in this study
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Chambéry, France
- Dijon, France
- Lyon, France
- Pierre-Bénite, France
- Pringy, France
- Saint-Priest-en-Jarez, France
- Villejuif, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Chambéry, France; Dijon, France; Lyon, France; Pierre-Bénite, France; Pringy, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.