Study

Principle Investigator contacted

Additional information requested

Answers provided

Allison 2016

Kelly Allison

Randomisation process

Blinding process

How was the study analysed?

Exclusion criteria

How was missing data dealt with?

Baseline characteristics

Duration of study intervention

Was a power calculation performed?

Results‐overall survival, adverse events, recurrence‐free survival, cancer‐specific survival, weight loss from baseline, cardiovascular and metabolic event frequency, change in quality of life from baseline

Funding source

Conflicts of interest

"The coordinating center used a computer generated algorithm to produce the randomization envelopes for each clinical site, with the general parameters of randomizing 1:1:1 across the three conditions. The envelopes are then chosen sequentially as each participant was enrolled."

"There was no blinding. The outcome assessments were conducted by study coordinators and trained medical personnel (for blood draws, DEXA). The coordinators knew which condition the participants were in, but other medical personnel were not informed."

"Given we only had pre‐post assessment data and our main analyses used paired t‐tests and correlations, we were unable to do intention‐to treat analyses."

"Exclusion criteria included: age less than 18, current or recent participation in a weight loss program or use of weight loss medications; uncontrolled serious medical or psychiatric condition(s) that would affect the patient’s ability to participate in the interventional study; invasive malignancy other than EC or non‐melanoma skin cancer which required active treatment currently or within the last 5 years, or current pregnancy."

"Given the pre‐post assessment design, were excluded participants for variables that were not completed."

See Characteristics of included studies. Data on co‐morbidities, performance status and type of endometrial cancer were not provided.

" 6 months"

"No ‐ From the grant: The purpose will be to provide estimates for the size of an intervention effect achievable by the experimental intervention in order to power and justify a grant application for a full‐scale trial of a weight loss program in women with endometrial cancer. With a sample size of 30 participants per group, the true difference in mean weight loss between the groups can be estimated with a 95% confidence interval size of ±0.50σ, where σ is the population standard deviation of weight loss, assumed in this calculation to be the same in each of the two intervention groups and the control group. We will assess the comparability of variance across the groups and do exploratory analyses of possibly variance‐stabilizing transformations. Because this is a pilot study to derive parameters to design an appropriately‐powered study, hypothesis testing is not a primary goal of the statistical analysis of the data, although p‐values will be calculated."

See Data and analyses. No data provided on adverse events, recurrence‐free and cancer‐specific survival

"Cross‐TREC study funded by NCI U54‐CA155850 – University of Pennsylvania; U54 CA155626 – Harvard University; U54 CA155496CC – Washington University; U01 CA116850 – Fred Hutchinson Cancer Research Center."

None declared

McCarroll 2014

Michele McCarroll

Single‐ or multi‐centre study?

Reasons for non‐attendance at follow‐up visits

Methods of group allocation concealment

Prospectively published protocol?

Results‐overall survival, adverse events, recurrence‐free survival, cancer‐specific survival, weight loss from baseline, cardiovascular and metabolic event frequency, change in quality of life from baseline

Single centre

None provided

"Physician counseling was standardized. Clinical guidelines for professionals on the identification, evaluation, and treatment of overweight and obesity in adults, according to the NIH should include dietary therapy, behavior therapy, and an increase in physical activity. They recommend that the clinician and the patient devise goals and a treatment strategy for weight loss with periodic weight checks. A guideline for physicians consisting of a laminated 3 x 5 card was given to all treating physicians as a reminder of patient teaching points. Due to the interventions performed by the study team (dietitian, Physical therapist, psychologist, etc.), they were able to know who was in each group."

"No"

See Data and analyses

von Gruenigen 2009

Michele McCarrroll

Single‐ or multi‐centre study?

Reasons for non‐attendance at follow‐up visits

Methods of group allocation concealment

Prospectively published protocol?

Results‐overall survival, adverse events, recurrence‐free survival, cancer‐specific survival, weight loss from baseline, cardiovascular and metabolic event frequency, change in quality of life from baseline

Single centre

None provided

"Physician counselling was standardized. Clinical guidelines for professionals on the identification, evaluation, and treatment of overweight and obesity in adults, according to the NIH should include dietary therapy, behavior therapy, and an increase in physical activity. They recommend that the clinician and the patient devise goals and a treatment strategy for weight loss with periodic weight checks. A guideline for physicians consisting of a laminated 3 x 5 card was given to all treating physicians as a reminder of patient teaching points. Due to the interventions performed by the study team (dietitian, Physical therapist, psychologist, etc.), they were able to know who was in each group."

No

See Data and analyses