Diet and Physical Activity Intervention in CRC Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The University of Hong Kong
Sponsor:
Collaborator:
World Cancer Research Fund International
Information provided by (Responsible Party):
Dr. Ho Wai-chu Judy, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01708824
First received: October 11, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Behavioral: Dietary
Behavioral: Physical activity
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Whether the PA and dietary intake targets are met at the end of intervention; [ Time Frame: at the end of 12 months of intervention ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Magnitude of change in PA level using objective accelerometry [ Time Frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention) ] [ Designated as safety issue: No ]
  • Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ); [ Time Frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention) ] [ Designated as safety issue: No ]
  • Rate and determinants of compliance with intervention; [ Time Frame: at the end of 12 months of intervention ] [ Designated as safety issue: No ]
    Rates of compliance - measured by rate of completion of assignment; determinants of compliance measured by a questionnaire

  • Facilitators and barriers to intervention [ Time Frame: at the end of intervention ] [ Designated as safety issue: No ]
    Measured by (a) qualitatively during the last group meeting and (b) quantitatively by questionnaire

  • Measurement of theoretical constructs underlying PA and dietary interventions [ Time Frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention) ] [ Designated as safety issue: No ]
    Using questionnaire specifically desinged to measure these theoretical constructs

  • Other possible health benefits arising from the intervention [ Time Frame: at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention) ] [ Designated as safety issue: No ]

    including

    1. Changes in body composition via body mass index (BMI)
    2. Changes in body fat and/or visceral fat via waist-hip ratio (WHR) and bioelectrical impedance analysis
    3. Physical fitness in the form of submaximal oxygen uptake as predicted by 6-minute ergometry
    4. Quality-of-life/mood via validated tools (SF12, FACT, HADS and PSS);

  • Possible side effects arising from the intervention [ Time Frame: at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention) ] [ Designated as safety issue: Yes ]

    including

    1. PA-associated injury
    2. Dietary deficiency - (i) anaemia (haemoglobin level); (ii) energy and protein deficiency


Estimated Enrollment: 224
Study Start Date: April 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  1. <5 servings of red/processed meat weekly; <2 servings would be processed meat
  2. 2 servings of refined grains daily
Experimental: physical activity

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

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)
Experimental: dietary and physical activity
Meeting both the dietary and physical activity targets
Behavioral: 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: Physical activity

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)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708824

Contacts
Contact: Judy WC Ho, MBBS 852 2255 4762 judyho@hku.hk

Locations
China
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Hester Cheung, MBBS       cheuys@ha.org.hk   
Princess Margaret Hospital Recruiting
Hong Kong, China
Contact: SM Hui, MBBS       huism@ha.org.hk   
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Judy WC Ho, MBBS    852 2255 4762    judyho@hku.hk   
Principal Investigator: Judy WC Ho, MBBS         
Yan Chai Hospital Recruiting
Hong Kong, China
Contact: CK Kong, MBBS       kck326@ha.org.hk   
Sponsors and Collaborators
The University of Hong Kong
World Cancer Research Fund International
Investigators
Principal Investigator: Judy WC Ho, MBBS Queen Mary Hospital, University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ho Wai-chu Judy, Consultant, Honorary Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01708824     History of Changes
Other Study ID Numbers: WCRF 2012/595
Study First Received: October 11, 2012
Last Updated: May 15, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
colorectal cancer
cancer survivor
western pattern diet
physical activity
behavioral intervention
acceptability
feasibility
randomized controlled trial
compliance

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014