None listed
Conditions
Brief summary
This study aims to investigate whether a 5-week text message program to support pain self-management works at least as well as a 5-week personally tailored cognitive behavioural therapy (CBT)-based pain self-management program run by a hospital pain clinic. Who is it for? You may be eligible for this study if you are an adult who has finished treatment for early-stage breast cancer and continue to experience ongoing pain that affects daily life. Study details About 80 participants will take part in this study. Participants will be randomly allocated (like flipping a coin) to one of two groups: - a mobile phone program that sends two supportive text messages per day for 5 weeks, or - a personally tailored cognitive behavioural therapy (CBT)-based pain self-management program delivered through the hospital pain clinic (format may be group-based, individual sessions, or self-guided materials based on an initial assessment). Both groups will also receive a self-help pain management book and workbook, and will continue to receive all their usual care from their doctors. Participants will complete short online questionnaires about pain, daily activities, mood, fatigue, work, and satisfaction at the start of the study, at 5 weeks, 9 weeks, and 3 months after starting the program. Some participants may also be invited to take part in a one-off telephone interview about their experience. It is hoped that the results of this study will show whether the text message program can be a convenient and acceptable alternative to group pain self-management programs for people living with pain after breast cancer.
Interventions
mHealth text messaging pain self-management program (intervention)
Participants allocated to this arm receive a 5-week, consumer co-designed SMS pain self-management program in addition to usual care. From Day 1 they receive a welcome SMS, then two one-way SMS messages per day for 5 weeks (morning and evening; ~70 messages total) delivered to their own mobile phone.
Approximate SMS length: Messages are designed to be brief and readable on a phone screen, typically ~120–160 characters (one stand
mHealth text messaging pain self-management program (intervention) Participants allocated to this arm receive a 5-week, consumer co-designed SMS pain self-management program in addition to usual care. From Day 1 they receive a welcome SMS, then two one-way SMS messages per day for 5 weeks (morning and evening; ~70 messages total) delivered to their own mobile phone. Approximate SMS length: Messages are designed to be brief and readable on a phone screen, typically ~120–160 characters (one standard SMS); some messages may be longer (sent as 2 SMS segments, up to ~320 characters) particularly when including a short hyperlink to trusted web/video resources. Content: Messages provide brief education about persistent pain, reassurance/validation, pacing and activity tips, goal-setting prompts, cognitive-behavioural coping strategies, motivational support, and links to trusted online resources/videos. Book/workbook integration: Participants also receive the self-help book Manage Your Pain and a simple workbook to record progress and practice skills. The SMS messages complement and may prompt use of the book/workbook (e.g., reminders to try a strategy, record goals, or practise a technique), but the book/workbook are supporting components provided alongside the SMS program. Expected engagement with book/exercises: Engagement is self-guided. Participants are expected to practise the techniques introduced via SMS (and to use the workbook to record and reinforce practice), but no fixed minimum duration or frequency is mandated beyond routine participation in the 5-week program. Delivery platform and fidelity: Messages are automated via a secure SMS platform; delivery metrics (messages sent/delivered) are logged electronically to monitor fidelity/adherence. Usual care: All participants continue to receive usual oncology care and primary care.
Sponsors
Northern Sydney Local Health District (NSLHD)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older with histologically confirmed early-stage breast cancer (stages I or II) who have completed primary treatment (surgery with or without chemotherapy and/or radiotherapy) within the past 2 years (endocrine therapy permitted), have self-reported persistent (chronic) pain for longer than 3 months and self-reported pain that is moderate or higher on average, or very bothersome, or interfering with function at baseline, are receiving follow-up care at one of the participating study sites (Northern Sydney Cancer Centre or Peter MacCallum Cancer Centre), own and use a mobile phone capable of receiving SMS, and are able to provide informed consent and complete questionnaires in English.
Exclusion criteria
Advanced or metastatic breast cancer (stage III or IV); insufficient English to provide informed consent or complete study procedures; and any condition judged by the investigators to make participation unsafe or impractical (for example, severe cognitive impairment, uncontrolled psychiatric illness, or serious unstable medical comorbidity); Previously participated in a pain self-management program since completing cancer treatment (in person or online).
Outcome results
None listed