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PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience

PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectivenessness-Implentation trial to optimise Symptom control and health service Experience. A randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in cancer patients, focusing on patient outcomes.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001290987
Acronym
PROMISE
Enrollment
600
Registered
2020-11-30
Start date
2021-09-14
Completion date
2023-06-30
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is investigating whether routine collection of patient-reported outcome measures electronically at regular timepoints will have an impact on cancer patients symptoms and the number of hospital admissions. Who is it for? You may be eligible for this study if you are 18 or older, you have been diagnosed with an invasive solid cancer and you are about to start or have recently started treatment at one of the study hospitals in Queensland. Study details Participants enrolled in this study will be allocated to one of two study groups by chance. Participants allocated to the first group will be asked to complete a short questionnaire about their symptoms and any treatment side effects experienced on a schedule of either weekly, fortnightly or monthly depending on site the participant attends. It is anticipated that filling in the questionnaire will take about 10 minutes. Participants allocated to the second group won't be asked to complete any questionnaires prior to their treatment or follow-up visits, however, they will be asked you to complete questionnaires at regular time points over a 2 year period from consenting to the study. A pre-planned sub-study will assess the effects of the electronic symptom and treatment questionnaires on participants’ partners and/or carers (PROMISE-Carers Substudy. It is hoped this research will determine whether additional collection of patient symptoms and any treatment side effects will result more effective cancer patient care and have a positive impact on unplanned hospital presentations/admissions.

Interventions

e-Prom (electronic patient reported outcome measures) comprising of a short questionnaire administered via an electronic platform prior to clinic appointments (during treatment and follow-up) and monthly or as desired by the patient between follow-up appointments. The tools provide information only and thus are not classed as medical devices. It is anticipated that the e-PROM will take 10 minutes to complete, The questionnaires are sent by link via email/SMS and will be self-administered, the li

e-Prom (electronic patient reported outcome measures) comprising of a short questionnaire administered via an electronic platform prior to clinic appointments (during treatment and follow-up) and monthly or as desired by the patient between follow-up appointments. The tools provide information only and thus are not classed as medical devices. It is anticipated that the e-PROM will take 10 minutes to complete, The questionnaires are sent by link via email/SMS and will be self-administered, the links are monitored by research nurse. The overall duration of e-PROM use will be up to 2 years from date of consent.

Sponsors

QIMR Berghofer Medical Research Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age at least 18 years diagnosed with invasive solid cancer about to start or recently started treatment at one of the study sites

Exclusion criteria

A tumour type or characteristic that is not appropriate for inclusion at the discretion of the Site Investigator and Coordinating PI e.g.: o Will not return to the site for regular treatment/follow-up o Already using or would normally use an e-PROM tool at that site • Treated with surgery only • Current participation in another study that requires completion of similar PROMs • Unable to provide informed consent • Unable to complete the e-PROM tools remotely (e.g. a comorbid condition affecting vision, cognition or dexterity or no internet access at home) • Unable to complete the study questionnaires in English • Unwilling to consent to data linkage In addition, participants who consent but do not complete the Baseline Study Questionnaire will be excluded post-consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026