Diet and Physical Activity Intervention in CRC Survivors
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ClinicalTrials.gov Identifier: NCT01708824 |
Recruitment Status
:
Recruiting
First Posted
: October 17, 2012
Last Update Posted
: May 12, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Behavioral: Dietary Behavioral: Physical activity | Phase 2 |
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 (Clinical Trial) |
Estimated Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (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 |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | June 2017 |
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
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Experimental: physical activity
Physical activity intervention with the following targets:
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Behavioral: Physical activity
Physical activity intervention with the following targets:
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Experimental: dietary and physical activity
Meeting both the dietary and physical activity targets
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Behavioral: Dietary
Dietary intervention to meet the target of
Physical activity intervention with the following targets:
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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
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- Whether the PA and dietary intake targets are met at the end of intervention; [ Time Frame: at the end of 12 months 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
- 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) ]
- 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) ]
- Rate and determinants of compliance with intervention; [ Time Frame: at the end of 12 months of intervention ]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 ]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) ]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) ]
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);
- 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) ]
including
- PA-associated injury
- Dietary deficiency - (i) anaemia (haemoglobin level); (ii) energy and protein deficiency

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven colorectal adenocarcinoma;
- Within one year of completion of main cancer treatment
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708824
Contact: Judy WC Ho, MBBS | 852 2255 4762 | judyho@hku.hk |
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 |
Principal Investigator: | Judy WC Ho, MBBS | Queen Mary Hospital, University of Hong Kong |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Judy Wai-Chu Ho, Consultant, Honorary Clinical Associate Professor, The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01708824 History of Changes |
Other Study ID Numbers: |
WCRF 2012/595 |
First Posted: | October 17, 2012 Key Record Dates |
Last Update Posted: | May 12, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | no consent has been obtained to make individual participant data available |
Keywords provided by Dr. Judy Wai-Chu Ho, 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |