RecruitingACTRN12616001251415

A smartphone application for people with cancer to help reduce distress and unmet needs.

M-Health: Efficacy and Cost-effectiveness of a smartphone App to reduce distress and unmet needs in people with cancer (ACE): a randomized controlled trial.


Sponsor

Deakin University - Professor Trish Livingston

Enrollment

250 participants

Start Date

Feb 24, 2017

Study Type

Interventional

Conditions

Summary

The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of the ACE smartphone application for reducing distress and unmet needs in cancer patients. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been newly diagnosed with any cancer type including both solid tumors and haematological cancer stages 1-3, attending day oncology centers for cycle 2-5 of adjuvant chemotherapy or fraction 2-5 for radiotherapy treatment for cancer. You must also speak English and have access to a Smartphone or similar tablet device (Android or iOS). Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the ACE smartphone application or to receive standard care with no smartphone application. Those in the ACE group will receive access to the application for four months. The ACE application allows participants to view and amend their existing appointments, provides links to cancer information and improved access to the Cancer Council Information and Support Service helpline. The application will also ask participants to rate their level of distress once per month, and participants with elevated distress levels will be referred to the Cancer Council Helpline for a follow-up support phone call. All participants will complete a number of questionnaires relating to their distress, quality of life and use of healthcare resources at enrollment and 4 and 12 months after enrolment. It is hoped that this study will show that the ACE smartphone application is a cost-effective tool for reducing distress and unmet needs in cancer patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a smartphone app called ACE that may help people newly diagnosed with cancer feel less distressed and more supported during treatment. The app helps patients track appointments, access cancer information, rate their distress levels, and connect with support services. You may be eligible if: - You are 18 years of age or older - You have been newly diagnosed with any type of cancer (stages 1–3) with a goal of cure - You are attending a day oncology center for early cycles or fractions of chemotherapy or radiotherapy - You can read and write in English - You have access to a smartphone or tablet (Android or iOS) You may NOT be eligible if: - You have cognitive dysfunction such as severe dementia or psychosis (as assessed by an oncology nurse) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The smartphone application comprises: a) the free downloadable ACE application to a smartphone or similar tablet device, providing patients access to their appointments; cancer information, impro

The smartphone application comprises: a) the free downloadable ACE application to a smartphone or similar tablet device, providing patients access to their appointments; cancer information, improved access to the Cancer Council 13 11 20 Information and Support Service that links them by telephone follow up to a range of community based supportive care services as required; and b) identification of distress with subsequent follow up by the Cancer Council 13 11 20 Information and Support Service for referral to psychological services. Those with elevated levels will be signaled by IT services and referred onto the 13 11 20 service for follow up with a name and contact telephone number. This intervention supports the physical, psychological, social, and information needs of people with cancer and aims to reduce unmet needs and distress of people with cancer while improving their ability to participate in their own health care. For participants randomized into the intervention group, the ACE application will be downloaded onto their Smartphone or similar tablet device and they will be shown features of the app. For example, the ‘Appointments’ feature will allow participants to view their scheduled upcoming appointments and enable participants to view details of each booking and facilitate requests to re-schedule existing bookings (which will trigger an automatic email to oncology reception at their health service with subsequent telephone follow up to confirm change in appointment). Other features include cancer information including links to reputable cancer specific websites for the participant to access; hospital maps for navigating around the hospital, improved access to the Cancer Council 13 11 20 telephone support service and available peer and online support groups; information on allied health services available at their health service, prompt to complete the Distress Thermometer (DT) at four time points: baseline and monthly thereafter for 3 months with follow up by the Cancer Council 13 11 20 Service for those with levels 7 or higher, which will trigger an automatic email to the Cancer Council 13 11 20 Service to follow up with the patient within 4 hours. In order to monitor adherence, monthly notifications will be sent to each participant through the app to complete the distress thermometer on the due date. Participants will be able to use the ACE application for a duration of four months.


Locations(3)

Box Hill Hospital - Box Hill

VIC, Australia

Epworth Richmond - Richmond

VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

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ACTRN12616001251415


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