Diet and Physical Activity Intervention in CRC Survivors

NCT01708824 | Unknown Phase 2

• 1 other identifier: WCRF 2012/595
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; cancer survivor; western pattern diet; physical activity; behavioral intervention; acceptability; feasibility; randomized controlled trial; compliance

Outcome Measures

Primary Outcomes (1)

• 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. 1. PA group: achieve PA targets or not 2. Dietary group: achieve dietary target or not 3. PA + dietary group: achieve both PA and dietary targets or not 4. Control group: achieve PA or dietary target or not

  at the end of 12 months of intervention

Secondary Outcomes (7)

• 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;

  at the end of 12 months of intervention

• Facilitators and barriers to intervention

  at the end of intervention

• Measurement of theoretical constructs underlying PA and dietary interventions

  6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)

Study Arms (4)

dietary

EXPERIMENTAL

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

physical activity

EXPERIMENTAL

Physical activity intervention with the following targets: 1. General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week); 2. Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)

Behavioral: Physical activity

dietary and physical activity

EXPERIMENTAL

Meeting both the dietary and physical activity targets

Behavioral: Dietary; Behavioral: Physical activity

usual care

NO INTERVENTION

Follow the general lifestyle advice in accordance with the recommendations of the Department of Health in Hong Kong available in the public domain

Interventions

Dietary BEHAVIORAL

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

dietary; dietary and physical activity

Physical activity BEHAVIORAL

Physical activity intervention with the following targets: 1. General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week); 2. Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)

dietary and physical activity; physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven colorectal adenocarcinoma;
• Within one year of completion of main cancer treatment

You may not qualify if:

• Persistent/recurrent disease upon recruitment;
• Current cancer treatment;
• Hereditary CRC syndromes;
• Known contraindication to PA;
• Illiteracy;
• Weekly red/processed meat \< 5 servings and daily refined grains \< 2 servings
• Weekly MPA \> 300 minutes

Sponsors & Collaborators

• The University of Hong Kong: lead
• World Cancer Research Fund International: collaborator

Study Sites (4)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

RECRUITING

Princess Margaret Hospital

Hong Kong, China

RECRUITING

Queen Mary Hospital

Hong Kong, China

RECRUITING

Yan Chai Hospital

Hong Kong, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 34433608 DERIVED

• 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.

  PMID: 32072434 DERIVED

• 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.

  PMID: 23688320 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity; Patient Compliance

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Judy WC Ho, MBBS

  Queen Mary Hospital, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy WC Ho, MBBS

CONTACT

852 2255 4762; judyho@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Honorary Clinical Associate Professor

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 17, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)