None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the efficacy of a behavioural intervention using Fitbit devices in increasing physical activity levels in gynaecological and colorectal cancer survivors at risk of cardiovascular disease. Who is it for? You may be eligible to enroll in this trial if you are aged 18 to 80 years, completed active cancer treatment for a gynaecological or colorectal cancer within the last 5 years, are currently in remission, and you are undergoing follow-up care at St. John of God Subiaco Hospital, WOMEN Centre in West Leederville or Hollywood Private Hospital in Nedlands, Western Australia. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the Fitbit behavioural intervention or standard care. Participants in the Fitbit behavioural intervention group will receive a Fitbit physical activity tracker device to be used to monitor activity during waking hours for 24 weeks. These participants will also receive two group information sessions in weeks 1 and 4, providing information on how to use the Fitbit and on setting and meeting physical activity goals. Participants in the standard care group will receive printed information relating to physical activity guidelines, but no Fitbit device or group sessions. After 24 weeks, they will be offered the option to try the Fitbit device for 6 weeks. Researchers will monitor physical activity levels over the 24 week intervention period, take height and weight measurements, and participants will be asked to complete questionnaires relating to their quality of life and levels of physical activity. It is hoped that the findings from this trial will evaluate whether this Fitbit behavioural intervention is feasible and effective for increasing physical activity levels in gynaecological and colorectal cancer survivors.
Interventions
The intervention arm will receive a Fitbit to use to monitor physical activity for the duration of the 12-week intervention. Participants who are randomised to the intervention arm will also attend two group sessions which will target goal-setting and action-planning skills.
The treatment group will be able to collect the Fitbit post-randomisation. Participants will be able to pick the Fitbit up from the hospital, signing it out upon collection at their first group meeting. They will be asked
The intervention arm will receive a Fitbit to use to monitor physical activity for the duration of the 12-week intervention. Participants who are randomised to the intervention arm will also attend two group sessions which will target goal-setting and action-planning skills. The treatment group will be able to collect the Fitbit post-randomisation. Participants will be able to pick the Fitbit up from the hospital, signing it out upon collection at their first group meeting. They will be asked to wear the Fitbit as much as possible during the 12-week intervention (at least 8 hours per day, preferably all waking hours), and will be encouraged to download Fitbit software that will assist in tracking their physical activity. Use of the Fitbits will provide participants with a practical and convenient method for monitoring their activity. Throughout the 12-week intervention, participants in the treatment group will be required to attend two 1-hour group sessions. The first group session will be held in week 1, and the second in week 4 of the study. Session one will focus on introducing participants to the Fitbit and giving instructions on how to use this device as a self-monitoring tool. Participants will complete goal-setting worksheets (Appendix F - attached to ANZCTR registration form) to set their activity goals for the following 12 weeks. Behaviour change specialists SH and CMS will assist participants with effective action planning, goal-setting and self-monitoring. Session two will attend to support needs and help participants to plan for and overcome barriers to increasing their physical activity level. Participants will also be able to adjust previously established goals, if necessary. This session will also allow for trouble-shooting of any problems or queries that participants encounter regarding Fitbit wear and use. Participants will take all worksheets from the sessions home with them, to assist with achieving their goals. At the end of the 12-week intervention, all participants should have completed two group sessions. Although this is not required, it is recommended that participants will also meet and build rapport with other participants in their neighbourhood outside of the meetings to boost their support and provide a sense of accountability. A final booster message will be sent to participants via text message or email (according to participant preference) at week 6. In keeping with the theme of self-monitoring and support needs, this booster message will contain a brief note of encouragement and a recommendation to track physical activity, with the aim of meeting the government guidelines. Participants will attend their end of intervention assessment at 12 weeks. At 24 weeks (twelve weeks post-intervention), participants will attend their final follow-up assessment. Participants will be required to return their Fitbit within the fortnight following the 24-week intervention. Following completion of the trial, participants will be invited to give feed back on effective components of the intervention via semi-structured interviews.
Sponsors
St. John of God Subiaco Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) Gynaecological or colorectal cancer survivors undergoing follow-up at St. John of God Subiaco Hospital, WOMEN Centre in West Leederville, and Hollywood Private Hospital in Nedlands, Western Australia. 2) Patients have completed active cancer treatment (surgery and/or radiotherapy and/or chemotherapy) within the last 5 years (excluding hormone therapy). 3) Have comorbidities resulting in increased CVD risk, as identified through hospital medical records (i.e., on blood pressure medication or have blood pressure >150/90mm Hg, BMI >28, hypercholesterolemia >5.2mmol/L), OR an American Society of Anaesthesiologists (ASA) score of 2 or 3 (in the absence of appropriate medical records). 4) Are in remission at the time of recruitment. 5) Are aged 18-80 years at recruitment. 6) Are English-reading and speaking. 7) Live locally within 100km of Perth. 8) Have no surgery planned during the 6 months following recruitment. 9) Are willing and able to give informed consent to participate in the study. 10) Are willing to maintain contact with the investigators for the 6 months following recruitment. As described above in criteria 3), comorbidity will be assessed using available medical records of BMI, blood pressure and cholesterol. In the absence of this data, individuals will be recruited based on their ASA score at time of treatment. Only those with an ASA score of 2 or 3 will be eligible for recruitment. An ASA score from 1-4 is assigned to patients upon admission to hospital for a surgical procedure. A low ASA score indicates that the patient is at minimal cardiovascular risk, and a higher ASA score suggests that the patient suffers from comorbidities that may pose a threat to their life. Participants with ASA scores of 2 or 3 will have comorbidities such as hypertension, hypercholesterolemia, hyperlipidaemia, and elevated BMI, putting them at risk of CVD. The ASA score is globally recognised as an indicator of physical health status of patients prior to undergoing surgery (Owens, Felts & Spitznagel, 1978).
Exclusion criteria
1) Undergoing treatment for cancer. 2) Have completed cancer treatment >5 years prior to recruitment. 3) Have an ASA score of 1 or 4. 4) Are younger than 18 years or older than 80 years of age. 5) Have recurrent or metastatic disease. 6) Have a diagnosis of a severe psychiatric illness. 7) Have cardiac abnormalities including unstable angina or recent myocardial infarction. 8) Have any severe disability that may affect physical function including severe arthritis. 9) Are currently enrolled in a health behaviour trial or program such as Weight Watchers. Individuals who have been diagnosed with uterine carcinosarcoma (MMMT), uterine serous carcinoma, or ovarian cancer will be excluded during the screening process. These cancer subtypes are typically associated with a poor prognosis. By excluding these subtypes, we hope to avoid attempting to contact individuals who may be deceased. Individuals with an ASA score of 1 are unlikely to benefit from the project as it is expected that cardiovascular health improvements will be minimal in patients who are already in good health. Additionally, those with an ASA score of 1 do not fall into the target sample of ‘cancer survivors at high cardiovascular risk’. Individuals with an ASA score of 4 are considered to have significant life threatening comorbidities, deeming the intervention inappropriate for this group.
Outcome results
None listed