Wearable Activity Technology And Action-Planning (WATAAP) trial to promote physical activity in colorectal and endometrial cancer survivors at cardiovascular risk

Not Applicable

Completed

• Conditions: cancer; cardiovascular risk; Cancer - Womb (Uterine or endometrial cancer); Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Small bowel (duodenum and ileum)

• Registration Number: ACTRN12617000131358
• Lead Sponsor: St. John of God Subiaco Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-24
• Study Completion: 2018-04-30
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minutes of activity per week as measured by accelerometer wear for 7 days. [12 weeks after baseline];Minutes of sedentary time as measured by accelerometer wear for 7 days.[12 weeks after baseline. ]