Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)
This study is testing an online programme called 'iCALM', which helps people with advanced cancer deal with difficult feelings like sadness or anxiety. It's a new version of an existing programme that has already shown good results in helping people feel better. The main aim is to find out if this online course is easy for people to use, if they find it helpful, and if it makes a positive difference to their emotional wellbeing. Being able to access support online could be very useful for people who might find it hard to attend in-person sessions due to their illness or where they live. The study will compare those using iCALM with those receiving their usual care, and participants will answer questions about their feelings and satisfaction with the programme.
At a glance
What is this study about?
When someone has advanced cancer, it’s completely understandable that they might feel low, anxious, or stressed. Dealing with the illness itself and the side effects of treatments can be very tough. Sadly, many people facing these challenges don't always get the emotional support they need, perhaps because there aren't enough trained therapists or suitable programmes available.
Researchers previously developed a successful programme called 'Managing Cancer and Living Meaningfully' (CALM). It’s a short, one-on-one talking therapy designed to help people with advanced cancer manage their thoughts and feelings, and it has been shown to reduce or prevent depression. However, getting to all these sessions can be tricky for some.
That's why this new study is looking at 'iCALM', which is an online version of the CALM programme. The main idea is to see if an online course can offer similar benefits, making it easier for more people to access support from home. The study will check if iCALM is something people find useful and easy to follow, and if it helps them feel better emotionally and improves their overall wellbeing.
Key takeaways
- This study explores an online support programme for people with advanced cancer.
- It aims to help with emotional challenges like feeling down or anxious.
- The programme, iCALM, is a digital version of a previously successful face-to-face therapy.
- Participation involves online sessions and answering questionnaires about your feelings.
- It seeks to make emotional support more accessible to those who need it.
- You can withdraw from the study at any point.
Who may be eligible?
To join this study, you need to be at least 18 years old and able to read and write in English. It's important that you also have access to the internet and can commit to taking part in the online sessions.
The study is for people receiving care at the Princess Margaret Cancer Centre who have advanced or metastatic cancer. This includes certain types of lung, pancreatic, liver, ovarian, breast, or other cancers that have spread, and doctors expect you to live for another 12-18 months.
You cannot join if you have memory or concentration problems that would make it hard to take part. Also, if you’re already receiving another type of structured talking therapy at the Cancer Centre, you won't be able to participate in this particular 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 or older?
- Can you read and write in English easily?
- Do you have a reliable way to access the internet?
- Are you a patient at the Princess Margaret Cancer Centre with advanced or metastatic cancer?
- Are you feeling well enough mentally to take part in online sessions?
- Are you not currently having structured talking therapy for your cancer at Princess Margaret?
What does participation involve?
If you join this study, you'll be randomly put into one of two groups. One group will take part in the iCALM online programme, which involves a few online sessions. The other group will receive their usual care, but will be offered the iCALM programme at no cost once the study finishes.
Throughout the study, you'll be asked to complete some questionnaires when you start, and then again after 4, 8, and 12 weeks. These questionnaires will ask about your satisfaction with any support you're receiving, your mood, any anxieties you might have, and your general quality of life. Some participants will also be asked to take part in an interview to share their experiences of the iCALM programme.
Potential risks and benefits
Locations (1)
- Princess Margaret Cancer CentreVerified postcodeToronto, Canada
Common questions
What is 'advanced cancer' in this study?
In this study, 'advanced cancer' refers to cancer that has spread to other parts of the body (known as metastatic cancer), or certain cancers at a later stage, like stage III or IV. It applies to specific types of lung, pancreatic, ovarian, breast, and other cancers.
What does 'usual care' mean?
'Usual care' means the standard medical care and support you would normally receive for your cancer, outside of any specific study programme like iCALM.
Will I have to pay for the iCALM programme?
No, if you are part of the study, the iCALM programme will be provided at no cost. If you are in the 'usual care' group, you will still be offered iCALM for free at the end of the study.
How often will I need to complete questionnaires?
You will complete questionnaires when you first join the study, and then again after 4, 8, and 12 weeks.
What if I can't finish the online sessions?
You can stop participating in the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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