Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Brief Summary: Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


Options:
A: Arm Label: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: behavioral dietary intervention, Other: counseling intervention, Other: educational intervention, Other: preventative dietary intervention, Procedure: quality-of-life assessment | Arm Label: Without Counseling; Type: ACTIVE_COMPARATOR; Interventions: Procedure: quality-of-life assessment | Intervention Type: BEHAVIORAL; Name: behavioral dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: counseling intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: educational intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: preventative dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Lifestyle counseling, Without Counseling
B: Arm Label: Less Intensive Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Less Intensive | Arm Label: Intensive Group; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive Group | Intervention Type: BEHAVIORAL; Name: Less Intensive; Assigned to Arm(s): Less Intensive Group | Intervention Type: BEHAVIORAL; Name: Intensive Group; Assigned to Arm(s): Intensive Group
C: Arm Label: Shape-Up following cancer treatment; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Shape-Up following cancer treatment | Arm Label: Control intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Shape-Up following cancer treatment; Assigned to Arm(s): Shape-Up following cancer treatment
D: Arm Label: Mirena + Metformin; Type: EXPERIMENTAL; Interventions: Drug: Levonorgestrel, Drug: Metformin | Arm Label: Mirena; Type: EXPERIMENTAL; Interventions: Drug: Levonorgestrel | Arm Label: Mirena + Weight Loss Intervention; Type: EXPERIMENTAL; Interventions: Drug: Levonorgestrel | Intervention Type: DRUG; Name: Levonorgestrel; Assigned to Arm(s): Mirena, Mirena + Metformin, Mirena + Weight Loss Intervention | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Mirena + Metformin

Answer: C