Clinical trial NCT01708824: Diet and Physical Activity Intervention in CRC Survivors
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal cancer
cancer survivor
western pattern diet
physical activity
behavioral intervention
acceptability
feasibility
randomized controlled trial
compliance
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: World Cancer Research Fund International
First posted: 2012-10-17
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Whether the PA and dietary intake targets are met at the end of intervention;
timeFrame: at the end of 12 months of intervention
Secondary outcomes:
measure: Magnitude of change in PA level using objective accelerometry
timeFrame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
measure: Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ);
timeFrame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
measure: Rate and determinants of compliance with intervention;
timeFrame: at the end of 12 months of intervention
measure: Facilitators and barriers to intervention
timeFrame: at the end of intervention
measure: Measurement of theoretical constructs underlying PA and dietary interventions
timeFrame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
measure: Other possible health benefits arising from the intervention
timeFrame: at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention)
measure: Possible side effects arising from the intervention
timeFrame: at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: China
facility: Princess Margaret Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Yan Chai Hospital
Study officials:
affiliation: Queen Mary Hospital, University of Hong Kong
name: Judy WC Ho, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.