None listed
Conditions
Brief summary
This study will evaluate the feasibility of a multi-disciplinary program of lifestyle education (good nutrition and physical activity) and social support for women with endometrial cancer Who is it for? You may be eligible to join this study if you are a woman aged 18 and above, have a histologically confirmed diagnosis of endometrial cancer following surgery and are scheduled for or have recently commenced any type of adjuvant therapy (such as brachytherapy, chemotherapy or radiotherapy) at Peter MacCallum Cancer Centre (Melbourne). Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive usual care at their treating hospital which does not routinely involve referral to social work, physiotherapy or nutrition services. Participants in the other group will receive a weekly multi-disciplinary program of social support, lifestyle education (regarding nutrition and physical activity) and behavioural change support for 8 weeks provided by a multi-disciplinary team including a dietician, physiotherapist and social worker. The one-on-one sessions will cover education on diet, physical activity, weight management, support to change dietary and physical activity behaviours and social support. The first session is conducted face-to-face at the Peter MacCallum Cancer Centre with weekly follow-up sessions for an additional seven weeks (conducted remotely by video or telephone). The findings from this research will establish how feasible it is to provide this multi-disciplinary service to those with endometrial cancer and support future research in the area.
Interventions
Supportive care intervention of social support and lifestyle education (nutrition and physical activity (PA)) with behavior change support. In addition to usual care, women randomised to the intervention group will receive an eight-week multi-disciplinary program to improve lifestyle behaviours (nutrition and physical activity) coupled with social support and behaviour change techniques. The initial multi-disciplinary session (up to 1.5 hours duration) will be conducted as an individual face-to-face session involving all three clinicians at Peter MacCallum Cancer Centre. Subsequent weekly individual follow-up (20-30 minutes duration) will be completed via telehealth (or face-to face if preferred by participants). All intervention sessions will be scripted to ensure a standardised content is covered for all intervention group participants. Each intervention session will include aspects of social support, lifestyle education and behaviour change. The social worker will work with participants to identify issues which may act as barriers to participants being able to make changes to their current nutrition and physical activity behaviours. This may involve referral to support services within the community. The dietitian and physiotherapist will provide education regarding good nutrition and increasing physical activity which is individualized and based on baseline assessment findings and patient preferences. It is anticipated that many participants will choose walking as their preferred form of physical activity. Participants will be encouraged to exercise at a moderate intensity level, commencing at a minimum of 10 minute bouts and gradually increasing to meet the physical activity recommendations of 150 minutes of moderate intensity aerobic exercise per week. To increase social support for changing lifestyle behaviours a family member or friend of the intervention group participant will also be encouraged to attend face-to-face and telehealth consultations and participate in the PA program where possible. Recommended nutrition, weight management and PA and associated benefits for people with endometrial cancer will be discussed and standard written educational material, developed by the Peter MacCallum Cancer Centre, will be provided. Participants will work with the health professionals to establish a home-based PA program and develop individualised, patient-centred nutrition and PA-related short and longer-term goals. In addition to goal setting, behaviour change strategies will include action planning, barrier identification/problem solving, self-monitoring of behavioural outcomes (using an activity monitor and diary), relapse prevention/coping planning and providing feedback regarding performance.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Women with a histologically confirmed diagnosis of endometrial cancer (EC) following surgery and scheduled for or recently commenced adjuvant therapy (brachytherapy, radiotherapy, chemotherapy or any combination of these treatments). 2. Age 18 years or above at screening 3. Have provided written informed consent for the trial 4. Able to read and write English 5. ECOG performance status of 0-2 6. Available for follow up 7. Life expectancy greater than 3 months 8. Able to access telehealth for telephone or video consultations
Exclusion criteria
1. More than two weeks post commencement of adjuvant therapy 2. Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial 3. Concurrent, actively treated other malignancy or history of other malignancy treated within the past year 4. Stage 4 or recurrent disease 5. Comorbidities preventing participation in an unsupervised walking program 6. Unable to access telehealth for video or telephone consultations 7. Met PA guidelines for the past month