Diet and Physical Activity Intervention in CRC Survivors

Colorectal Cancer Clinical Trial

Official title:

The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01708824
• Other study ID #: WCRF 2012/595
• Status: Recruiting
• Phase: Phase 2
• First received: October 11, 2012
• Last updated: May 11, 2016
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: Judy WC Ho, MBBS
• Phone: 852 2255 4762
• Email: judyho[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent World Cancer Research Fund (WCRF) 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. Our literature review showed a paucity of published studies on lifestyle intervention in CRC survivors; none had investigated the effect of such intervention on cancer outcomes.

With advances in treatment, CRC survivors live longer. Many of them are motivated to make lifestyle changes. However, our qualitative research has shown a huge service gap in the provision of appropriate PA and dietary advice to CRC survivors. Many patients were unaware of the link between PA and diet with CRC outcome but most demonstrated acceptance of lifestyle intervention. Yet, there is currently no scientifically-based evidence to allow firm recommendations to be made.

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 (to 60 minutes of moderate PA 5 days/week) and (2) reduce consumption of a Western diet (<5 servings of red/processed meat weekly and 2 servings of refined grain daily).

We hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors with compliance rates of about 80%.

Settings and methods - The study follows the Medical Research Council Framework for the design and evaluation of complex interventions. Phases 0 and 1 (funded by WCRF) have been completed.

This application seeks funding for a 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 by questionnaire; (3) facilitators and barriers to behavioural change by questionnaire; (4) measurement of theoretical constructs underlying PA and dietary interventions by questionnaire; (5) possible health benefits (body composition, physical fitness, quality of life and mood) 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 (i.e. at baseline, 6, 12, 18 and 24 months after the start of intervention).

Impact - To the best of our knowledge, this is the first behavioural intervention model targeting PA and reduced consumption of a Western diet in CRC survivors. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically proven colorectal adenocarcinoma;

2. Within one year of completion of main cancer treatment

Exclusion Criteria:

1. Persistent/recurrent disease upon recruitment;

2. Current cancer treatment;

3. Hereditary CRC syndromes;

4. Known contraindication to PA;

5. Illiteracy;

6. Weekly red/processed meat < 5 servings and daily refined grains < 2 servings

7. Weekly MPA > 300 minutes

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Dietary
Dietary intervention to meet the target of <5 servings of red/processed meat weekly; <2 servings would be processed meat 2 servings of refined grains daily
• Physical activity
Physical activity intervention with the following targets: General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week); Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)

Locations

Country	Name	City	State
China	Pamela Youde Nethersole Eastern Hospital	Hong Kong
China	Princess Margaret Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
China	Yan Chai Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	World Cancer Research Fund International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether the PA and dietary intake targets are met at the end of intervention;	Whether the PA and dietary intake targets are met at the end of intervention; i.e.; PA group: achieve PA targets or not; Dietary group: achieve dietary target or not; PA + dietary group: achieve both PA and dietary targets or not; Control group: achieve PA or dietary target or not	at the end of 12 months of intervention	No
Secondary	Magnitude of change in PA level using objective accelerometry		6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)	No
Secondary	Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ);		6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)	No
Secondary	Rate and determinants of compliance with intervention;	Rates of compliance - measured by rate of completion of assignment; determinants of compliance measured by a questionnaire	at the end of 12 months of intervention	No
Secondary	Facilitators and barriers to intervention	Measured by (a) qualitatively during the last group meeting and (b) quantitatively by questionnaire	at the end of intervention	No
Secondary	Measurement of theoretical constructs underlying PA and dietary interventions	Using questionnaire specifically desinged to measure these theoretical constructs	6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)	No
Secondary	Other possible health benefits arising from the intervention	including; Changes in body composition via body mass index (BMI); Changes in body fat and/or visceral fat via waist-hip ratio (WHR) and bioelectrical impedance analysis; Physical fitness in the form of submaximal oxygen uptake as predicted by 6-minute ergometry; Quality-of-life/mood via validated tools (SF12, FACT, HADS and PSS);	at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention)	No
Secondary	Possible side effects arising from the intervention	including; PA-associated injury; Dietary deficiency - (i) anaemia (haemoglobin level); (ii) energy and protein deficiency	at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)	Yes