Active not recruitingNAINTERVENTIONAL

Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

This study aims to understand the long-term impact of rare ovarian cancer and its treatments, especially chemotherapy, on women's lives. While similar studies exist for men with testicular cancer, we know less about the long-term effects for women. Researchers want to assess chronic tiredness, overall quality of life, and other health issues that might appear years after treatment has finished. They will compare women who had surgery and chemotherapy with those who only had surgery, to see how different treatments affect their well-being. This will help improve care for future patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Francois Baclesse

Enrolment target

268

Start

07 May 2018

Estimated completion

01 Dec 2025

Germ Cell Tumor Sex Cord Stromal Tumor Malignant Non-epithelial Ovarian Tumors

What is this study about?

This study is called "Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy". It's looking into a specific type of ovarian cancer that is quite rare – either a germ cell tumour or a sex cord stromal tumour. These are different from the more common types of ovarian cancer. The study wants to understand how women who have had these rare ovarian cancers and also received chemotherapy are doing several years after their treatment has finished. It focuses on things like how tired they feel all the time (chronic fatigue), their general well-being and happiness (quality of life), and any other health issues that might appear later on because of the chemotherapy.

While we have some information about the long-term effects of similar treatments in men who had testicular cancer, we don't have as much research for women who have had these rare ovarian cancers. This study is important because it will help doctors and nurses understand more about the lasting effects of these illnesses and their treatments. By gathering this information, they can offer better support and care to women in the future who are going through similar experiences.

The researchers will compare two groups of women: those who had both surgery and chemotherapy, and those who only had surgery. This comparison will help them see what specific effects might be linked to chemotherapy. The study takes place across the country, aiming to get a broad picture of how women are doing after treatment.

Key takeaways

This study looks at long-term impacts of rare ovarian cancer.
It focuses on chronic tiredness, quality of life, and chemotherapy side effects.
It aims to fill gaps in knowledge about women's long-term health post-treatment.
Participation involves questionnaires and standard health checks.
Your contribution can help improve future care for women with rare ovarian cancers.

Who may be eligible?

To be part of this study, you need to be an adult woman, aged 18 or older. You must have been treated for a rare type of ovarian cancer (either a germ cell tumour or a sex cord stromal tumour). Your initial treatment, which involved surgery, must have finished more than two years ago, and you should currently be in remission (meaning the cancer is not active).

The study is particularly interested in women who had both surgery and chemotherapy, but also includes women who only had surgery. You can still take part if you had a relapse of cancer, as long as you've been in remission again for more than two years since your last treatment ended. You also shouldn't have any other active cancers, apart from certain types of very early skin or cervical cancers.

There are a few reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have a mental health condition that might make it hard to answer questions accurately or understand the study fully. Also, if you are not able to give your consent (permission) to join the study freely, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been treated for a rare ovarian cancer (germ cell or sex cord stromal tumour)?
Did you finish your initial treatment (surgery and/or chemotherapy) more than two years ago?
Are you currently in remission (cancer not active)?
Are you able to provide your consent (permission) freely?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form, which means you agree to be involved. The study involves two main parts. Firstly, you will be asked to fill out some questionnaires. These questionnaires will ask you about your living conditions, how tired you feel, and your overall quality of life. This helps researchers understand your day-to-day experiences.

Secondly, you would undergo some health checks. These would include assessments of your heart health, how well your lungs are working, your hearing, and some biological tests, which might involve blood samples. These checks help to identify any long-term effects of your previous chemotherapy. The study does not involve taking new medications. The total duration of your participation would involve these assessments at specific points, but the overall follow-up period isn't specified in this summary.

Potential risks and benefits

Taking part in this study could offer several benefits. You would be contributing valuable information that will help doctors better understand the long-term effects of rare ovarian cancer and its treatments. This could lead to improved care and support for women facing these conditions in the future. There are minimal risks associated with this study; answering questionnaires and undergoing standard health checks like heart, lung, hearing, and blood tests are generally safe. Any discomfort from blood tests would be minor and temporary. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

HEGP
Verified postcode
Paris, France
Centre Paul Papin
Verified postcode
Angers, France
CHU Besançon Jean MINJOZ
Verified postcode
Besançon, France
Institut Bergonié
Verified postcode
Bordeaux, France
CH Fleyriat
Verified postcode
Bourg-en-Bresse, France
Centre François Baclesse
Verified postcode
Caen, France
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France
Centre Léon Berard
Verified postcode
Lyon, France
Institut Paoli Calmettes
Verified postcode
Marseille, France
Centre Catherine de Sienne
Verified postcode
Nantes, France
Institut de Cancérologie de l'Ouest
Verified postcode
Nantes, France
GH Cochin Broca Hôtel-Dieu
Verified postcode
Paris, France

Common questions

What kind of ovarian cancer is this study about?

This study focuses on rare types of ovarian cancer: germ cell tumours and sex cord stromal tumours.

Why is this study important?

It helps us understand the long-term effects of these rare cancers and their treatments on women's lives, which isn't well understood yet. This can lead to better future care.

What does 'remission' mean in this study?

Remission means the cancer is currently not active in your body. For this study, you need to have been in remission for at least two years after your last treatment.

Will I have to take new medication if I join?

No, this study does not involve taking any new medications. It's about looking at your current health and past treatments.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, and it will not affect your ongoing medical care.