RecruitingNAINTERVENTIONAL

Feasibility of CALM in Patients With Ovarian Cancer

This study is exploring a new therapy called CALM (Managing Cancer And Living Meaningfully) for women recently diagnosed with advanced ovarian cancer or whose cancer has come back. The main aim is to see if this therapy is helpful and easy to provide in a hospital setting, and if women find it acceptable. Researchers also want to understand the level of stress symptoms women might experience at the start of their treatment. Participants will fill out questionnaires and some will attend CALM therapy sessions. The information gathered could help decide if a larger study is needed to see how effective CALM is at helping women cope with their cancer journey and related stress.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

10 Jun 2024

Estimated completion

10 Aug 2026

Patient Satisfaction Ovarian Cancer

What is this study about?

When you're diagnosed with advanced ovarian cancer, or if your cancer returns, it can be a really difficult time. This study is looking into a type of support called CALM, which stands for Managing Cancer And Living Meaningfully. It's a talking therapy designed to help people cope with the emotional and practical challenges that come with having cancer.

The main aim of this study is to see if offering CALM therapy soon after diagnosis or recurrence of ovarian cancer is practical and helpful in a hospital setting. We want to know if patients find it useful and easy to access, and if it can help with feelings of stress and worry that often come with a cancer diagnosis.

While CALM has been shown to help people later in their cancer journey, we don't yet know how well it works for those who have just been diagnosed or whose cancer has come back. The information we gather from this small study will help us understand if it's worth doing a bigger study to prove how effective CALM can be in supporting women at this crucial time.

Key takeaways

This study explores a therapy called CALM for ovarian cancer patients.
It aims to see if CALM is helpful for managing stress early after diagnosis or recurrence.
Participation involves questionnaires and optional CALM therapy sessions.
The study lasts about 6 months and does not involve new medications.
Results could lead to better support for women with ovarian cancer.

Who may be eligible?

To take part in this study, you need to be a woman who has recently been diagnosed with advanced ovarian cancer (stage III or IV), or whose ovarian cancer has returned at stage III or IV. You must be at least 18 years old.

It's important that you can understand and speak English well enough to complete questionnaires and take part in the CALM therapy sessions. Unfortunately, if you have any memory or thinking problems that would make it hard to participate, or if you are already receiving similar counselling from the Supportive Care Department at Princess Margaret Cancer Centre, you won't be able to join this study.

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 recently been diagnosed with advanced ovarian cancer (stage III or IV), or has your cancer returned at these stages?
Can you comfortably speak and understand English?
Are you currently NOT receiving counselling from the Supportive Care Department at Princess Margaret Cancer Centre?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to fill out some questionnaires at three different times: when you first join the study, and then again after 3 months and 6 months. These questionnaires will ask about your feelings and how you're coping.

You'll also be invited to attend between 3 and 6 sessions of CALM therapy. These are individual talking sessions designed to help you manage the challenges of living with cancer. The total length of your involvement in the study, from your first questionnaire to your last, will be about 6 months. There are no medications involved in this study.

Potential risks and benefits

Taking part in this study may offer you the benefit of receiving CALM therapy, which could help you cope with the emotional impact of your ovarian cancer. It could also help us learn more about how to best support women like you. However, filling out questionnaires and talking about your feelings might occasionally bring up difficult emotions. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is CALM therapy?

CALM stands for Managing Cancer And Living Meaningfully. It's a type of talking therapy designed to help people with cancer deal with their emotions and everyday challenges.

Will I have to take any new medicines?

No, this study does not involve any new medications. It focuses on talking therapy and questionnaires.

How long will I be involved in the study?

If you take part, you'll be involved for about 6 months, from when you start filling out questionnaires until your last follow-up.

What happens if I don't want to complete the therapy sessions?

You don't have to participate in the therapy sessions if you don't want to. Your medical care will not be affected regardless of your decision.

Why is this study important?

This study helps us understand if CALM therapy can help people cope with stress and difficulties soon after being diagnosed with ovarian cancer or if it returns, which could lead to better support for others in the future.

How to find out more

Megan A George, BSc

megan.george@uhn.ca 6475463114 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.