Diet and Physical Activity Intervention in CRC Survivors

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Dietary; Behavioral: Physical activity

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Queen Mary Hospital
    • Contact: Judy WC Ho, MBBS; Phone Number: 852 2255 4762; Email: judyho@hku.hk
    • Principal Investigator: Judy WC Ho, MBBS
  • Hong Kong, China
    • Recruiting
    • Princess Margaret Hospital
    • Contact: SM Hui, MBBS; Email: huism@ha.org.hk
  • Hong Kong, China
    • Recruiting
    • Yan Chai Hospital
    • Contact: CK Kong, MBBS; Email: kck326@ha.org.hk
  • Hong Kong, China
    • Recruiting
    • Pamela Youde Nethersole Eastern Hospital
    • Contact: Hester Cheung, MBBS; Email: cheuys@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary; Dietary intervention to meet the target of 1.<5 servings of red/processed meat weekly; <2 servings would be processed meat 2.2 servings of refined grains daily	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
Experimental: 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)	Behavioral: 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)
Experimental: dietary and physical activity; Meeting both the dietary and physical activity targets	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; Behavioral: 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)
No Intervention: usual care; Follow the general lifestyle advice in accordance with the recommendations of the Department of Health in Hong Kong available in the public domain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
Facilitators and barriers to intervention	Measured by (a) qualitatively during the last group meeting and (b) quantitatively by questionnaire	at the end of intervention
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)
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)
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)

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: World Cancer Research Fund International
• Investigators: Principal Investigator: Judy WC Ho, MBBS, Queen Mary Hospital, University of Hong Kong

Publications and helpful links

General Publications

• Wong JYH, Ho JWC, Lee AM, Fong DYT, Chu N, Leung S, Chan YYW, Lam SH, Leung IPF, Macfarlane D, Cerin E, Taylor AJ, Cheng KK. Lived experience of dietary change among Chinese colorectal cancer survivors in Hong Kong: A qualitative study. BMJ Open. 2021 Aug 25;11(8):e051052. doi: 10.1136/bmjopen-2021-051052.
• Ho M, Ho JWC, Fong DYT, Lee CF, Macfarlane DJ, Cerin E, Lee AM, Leung S, Chan WYY, Leung IPF, Lam SHS, Chu N, Taylor AJ, Cheng KK. Effects of dietary and physical activity interventions on generic and cancer-specific health-related quality of life, anxiety, and depression in colorectal cancer survivors: a randomized controlled trial. J Cancer Surviv. 2020 Aug;14(4):424-433. doi: 10.1007/s11764-020-00864-0. Epub 2020 Feb 18.
• Ho JW, Lee AM, Macfarlane DJ, Fong DY, Leung S, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Study protocol for "Moving Bright, Eating Smart"- A phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors. BMC Public Health. 2013 May 20;13:487. doi: 10.1186/1471-2458-13-487.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; colorectal cancer; randomized controlled trial; behavioral intervention; compliance; cancer survivor; feasibility; acceptability; western pattern diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: WCRF 2012/595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no consent has been obtained to make individual participant data available