Diet and Physical Activity Intervention in CRC Survivors

NCT ID: NCT01708824

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-06-30

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dietary

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: 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

Meeting both the dietary and physical activity targets

Group Type: EXPERIMENTAL

Dietary

Intervention Type: 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

Physical activity

Intervention Type: 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)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Cancer Research Fund International

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Judy Wai-Chu Ho

Consultant, Honorary Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy WC Ho, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, University of Hong Kong

Locations

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , China

Site Status: RECRUITING

Princess Margaret Hospital

Hong Kong, , China

Site Status: RECRUITING

Queen Mary Hospital

Hong Kong, , China

Site Status: RECRUITING

Yan Chai Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Judy WC Ho, MBBS

Role: CONTACT

judyho@hku.hk

852 2255 4762

Facility Contacts

Hester Cheung, MBBS

Role: primary

cheuys@ha.org.hk

SM Hui, MBBS

Role: primary

huism@ha.org.hk

Judy WC Ho, MBBS

Role: primary

judyho@hku.hk

852 2255 4762

CK Kong, MBBS

Role: primary

kck326@ha.org.hk

References

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.

Reference Type: DERIVED

PMID: 34433608 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32072434 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23688320 (View on PubMed)

Other Identifiers

WCRF 2012/595

Identifier Type: -

Identifier Source: org_study_id