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 |
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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. |
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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" |
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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." |
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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. |