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. 2023 Mar 27;2023(3):CD012513. doi: 10.1002/14651858.CD012513.pub3

Clark 2021.

Study characteristics
Methods Design: parallel, 2‐arm, single‐blind, randomised controlled trial
Prospective trial of survivors of endometrial cancer from September 2018 to December 2019. Survivors randomised 1:1
Setting: single‐centre in North Carolina Cancer Hospital, USA
Follow‐up: 12 weeks
Participants Number of participants enroled: 39 participants randomised; 19 into intervention arm and 20 into control arm
Inclusion criteria
Aged ≥ 18 years
Confirmed diagnosis of endometrial cancer and had completed therapy (surgery, chemotherapy or radiation) within past 6 months
No current evidence of endometrial cancer
BMI ≥ 25 kg/m2
Had approval from their treating physician to engage in moderate‐intensity physical activity
Had a smartphone with Bluetooth capabilities turned on
Had access to email
Exclusion criteria
Currently undergoing treatment for their cancer
Unable to read a sample message aloud
Pregnancy
History of angina or palpitations with exertion
History of uncontrolled pulmonary disease (COPD or asthma)
Have ≥ 1 significant medical conditions that in the physician's judgement precluded participation in the walking intervention.
Baseline participant characteristics
Mean age 55.7 years (range 36–76 years); intervention arm: mean age 55.3 years (range 36–76 years); control arm 56.4 years (range 43–68 years). Baseline BMI (not reported if mean or median) 36.7 kg/m2 in intervention arm and 35.9 kg/m2 in the control arm. Comorbid conditions, ECOG PS and ethnicity of participants not reported. Histological type, grade or stage of endometrial cancer not reported. Primary treatment not reported. 
Interventions Intervention arm
Received a fitness tracker and weekly tailored fitness messages
Quote: "Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3‐month study period."
Control arm
Received a fitness tracker without any fitness messages.
Quote: "No feedback messages"
Outcomes Primary outcomes
Overall survival: no deaths reported in either arm during study.
Adverse events: no adverse event in either arm during study.
Secondary outcomes
Recurrence‐free survival: not reported.
Cancer‐specific survival: no cancer‐specific deaths reported in either arm during study.
Weight loss: change in BMI from baseline at 3 months reported.
Cardiovascular and metabolic event frequency: not reported.
QoL: not reported.
Power
Power calculation performed, but there was insufficient detail to allow it to be replicated.
Quote: "Powered to detect a clinically significant change in daily step count of 2,000 steps. Wilcoxon Two‐sample test and student's T‐test was used for comparisons."
Notes Study authors contacted and poster sent, no further responses to data requests.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomised 1:1 but no information given regarding randomisation process.
Quote: "Survivors were randomized 1:1 to receipt or non‐receipt of weekly tailored feedback messages."
Allocation concealment (selection bias) Unclear risk Comment: no information given regarding any allocation concealment used.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: due to nature of intervention, participants were unblinded. Unclear how personnel were blinded.
Quote: "Masking: single (investigator)."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no information provided regarding who performed the outcome assessments and if they were blinded.
Quote: "Masking: single (investigator)."
Incomplete outcome data (attrition bias)
All outcomes High risk Follow‐up
Entered into study: 19 in intervention arm, 20 in control arm.
Completed study: 18 in intervention arm, 18 in control arm. Reason not completed documented as physician decision.
Missing data: step data missing in both intervention and control arm.
Quote: "Overall, 33% of intervention survivors versus 22% of control survivors had decline in fitness tracker use resulting in missing step data (p=0.46)."
Intention‐to‐treat analysis
Comment: no information provided on how missing data was dealt with.
Selective reporting (reporting bias) Unclear risk Comment: trial was registered prospectively on ClinicalTrials.gov but without publication/further information from study authors it was unclear if all prespecified outcomes were reported.
Other bias Unclear risk Source of funding: no information provided by study authors. 
Ethical approval: no information provided by study authors.
Conflicts of interest: no information provided by study authors.
Other sources: no information provided by study authors.