Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study
Brief Summary: Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent report concluded physical activity (PA) protects against colon cancer and foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is largely unknown.

Objectives \& hypothesis - Our study aims to evaluate the acceptability of two behavioural interventions for CRC survivors intended to improve cancer outcome and designed to (1) increase PA levels and (2) reduce consumption of a Western diet.

The investigators hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors.

Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors within 12 months of completion of cancer treatment and without evidence of persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of PA and dietary intake could be met at the end of intervention. Secondary outcome measures include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of theoretical constructs underlying PA and dietary interventions; (5) possible health benefits and side effects (PA-associated injury and nutritional deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months into intervention and then at 0, 6 and 12 months post-intervention.

Impact - If proven feasible, our intervention programme would pave way for a large randomized controlled trial testing the effect of PA and diet on the treatment outcome of CRC.


Options:
A: Arm Label: dietary; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary | Arm Label: physical activity; Type: EXPERIMENTAL; Interventions: Behavioral: Physical activity | Arm Label: dietary and physical activity; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary, Behavioral: Physical activity | Arm Label: usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary; Assigned to Arm(s): dietary, dietary and physical activity | Intervention Type: BEHAVIORAL; Name: Physical activity; Assigned to Arm(s): dietary and physical activity, physical activity
B: Arm Label: Nutritional counseling; Type: EXPERIMENTAL; Interventions: Procedure: Nutritional counseling | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Nutritional counseling; Assigned to Arm(s): Nutritional counseling
C: Arm Label: Immediate Lifestyle Intervention - Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention, Behavioral: Maintenance Intervention | Arm Label: Immediate Lifestyle Intervention - No Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Arm Label: Delayed Lifestyle Intervention - Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention, Behavioral: Maintenance Intervention | Arm Label: Delayed Lifestyle Intervention - No Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Intervention Type: BEHAVIORAL; Name: Lifestyle Intervention; Assigned to Arm(s): Delayed Lifestyle Intervention - Maintenance Program, Delayed Lifestyle Intervention - No Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - No Maintenance Program | Intervention Type: BEHAVIORAL; Name: Maintenance Intervention; Assigned to Arm(s): Delayed Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program
D: Arm Label: Intervention; Type: N/A; Interventions: Behavioral: educational/counseling intervention, Behavioral: therapeutic dietary intervention | Arm Label: Control; Type: N/A; Interventions: Behavioral: therapeutic dietary intervention | Intervention Type: BEHAVIORAL; Name: educational/counseling intervention; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: therapeutic dietary intervention; Assigned to Arm(s): Control, Intervention

Answer: A