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Trial registered on ANZCTR

Registration number

ACTRN12609001086257

Ethics application status

Approved

Date submitted

17/12/2009

Date registered

18/12/2009

Date last updated

31/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Promotion of healthy lifestyle and risk modification for cancer survivors and their partners/caregivers (ENRICH: Exercise and Nutrition Routine Improving Cancer Health)

Scientific title

A wait-list randomised controlled trial of a healthy lifestyle and risk modification program for cancer survivors and their partners/caregivers: changes in health behaviours.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

ENRICH

Linked study record

Health condition

Health condition(s) or problem(s) studied:

healthy lifestyle and risk modification program for cancer survivors and their partners/carers

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The ENRICH program will involve education and information for participants to set up their own home-based walking program with pedometer, their own resistance training program with Gymstick (exercise stick with elastic tubing), and healthy diet information provided via 6 face-to-face, 2 hour sessions, over 8 week period. During the session, participants will be provided with a pedometer, and given information/resources on how to start a walking program (ie. start slowly, plan walking routes, etc), and how to increase their number of steps. Participants will vary in their health status, ability, and current levels of physical activity, so the program is not prescriptive in advising all participants to meet a certain level/goal/duration. Participants will be able to set their own walking goals, & walking program, dependent on their ability. The goal for participants is simply to increase their number of daily steps, regardless of their baseline level of activity. For resistance training, during the ENRICH program sessions, participants will be shown two exercises (at each of 4 sessions) using the Gymstick (exercise stick with elastic tubing). Participants will have the opportunity to practice these during the session, have their technique corrected (if required), or modified (if health difficulties prevent certain exercises). Participants will be provided with information on how to perform these exercises at home, along with the number of repetitians & sets appropriate to their own ability and health. Participants are encouraged to perform resistance training on 3 occasions per week, although intensity & duration of resistance training exercises will vary depending on the health and ability of the participant. The home-based program components are unstructured, and up to the participant. These components are discussed during the program session and participants are encouraged to set and review weekly goals for their physical activity & diet behaviours. The Sessions will be delivered by two facilitators: an accredited Dietitian, and Exercise Physiologist, who will be able to tailor the program to the ability & needs of participants. The program aims to help people make life-long positive behaviour change, so participants will be encouraged to set their own activity & diet goals to work towards. The intervention aims for participants to increase their daily step count, perform resistance training at 3 sessions per week, and increase fruit and vegetable consumption.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

Wait-list control group who will receive the intervention after the program has been evaluated.

Control group

Active

Outcomes

Primary outcome [1]

physical activity levels measured by the Active Australia survey

Timepoint [1]

baseline (1 week prior to intervention commencement), 8 weeks after intervention commencement (at end of intervention program), 20 weeks after intervention commencement, 12 months after intervention

Primary outcome [2]

1 week of self-reported step counts, measured by pedometer

Timepoint [2]

baseline (1 week prior to intervention commencement), 8 weeks after intervention commencement (at end of intervention program), 20 weeks after intervention commencement, 12 months after intervention commencement

Primary outcome [3]

fruit and vegetable intake measured by the Diet Questionnaire for Epidemiological Studiesv2

Timepoint [3]

Primary outcome [4]

self-reported body mass index

Timepoint [4]

Primary outcome [5]

self-reported waist circumference

Timepoint [5]

Secondary outcome [1]

social support levels measured by Medical Outcomes Study (MOS) Social Support Survey

Timepoint [1]

Secondary outcome [2]

quality of life measured by Medical Outcomes Study Short Form survey (SF)-12

Timepoint [2]

Timepoint: baseline (1 week prior to intervention commencement), 8 weeks after intervention commencement (at end of intervention program), 20 weeks after intervention commencement, 12 months after intervention commencement

Secondary outcome [3]

Mediators of physical activity changes based on Social Cognitive Theory (behavioural goal; self-efficacy; positive outcome expectations; impediments; social support)

Timepoint [3]

Secondary outcome [4]

physical activity levels measured by the Active Australia survey

Timepoint [4]

Secondary outcome [5]

fruit and vegetable intake measured by the Diet Questionnaire for Epidemiological Studiesv2

Timepoint [5]

Secondary outcome [6]

self-reported body mass index

Timepoint [6]

Secondary outcome [7]

self-reported waist circumference

Timepoint [7]

Eligibility

Key inclusion criteria

Inclusion criteria for cancer survivor:·
*Have previously been diagnosed with a cancer of any type/site
*At time of program commencement, have completed all active treatment including surgery, chemotherapy, radiotherapy, immunotherapy, bone marrow transplants.·
*Signed medical clearance form from their doctor
*Score of 2 or less on Eastern Cooperative Oncology Group (ECOG)/World Health Organisaion (WHO) score:· 0 - Fully active, able to carry on all pre-disease performance without restriction;
1 - restricted in physically strenuous activity, but ambulatory and able to carry out work of a light and sedentary nature (eg. light house work, office work);
2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.;
3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours;
4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.;
5 – Dead·
Inclusion criteria for partner/carer:·
*Need to have signed medical clearance form;
*Score of 2 or less on ECOG/WHO score·
*Person they are caring for needs to also meet eligibility criteria above, even if the survivors chooses not to participate in the trial (eg. carer is not eligible if survivor is palliative or has passed away).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria for cancer survivor:·
*Restrictions of food consumption due to surgery
*Medical clearance form not completed or returned
*Not meeting Eastern Cooperative Oncology Group (ECOG)/World Health Organisaion (WHO) criteria of 2 or less (as per inclusion criteria)

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Potential participants who are interested and contact the Project Co-ordinator, will be asked a brief series of questions to ascertain their eligibility to participate. Potential participants will also be asked whether they are a cancer survivor or carer, and if cancer survivor, whether they have an interested partner or caregiver. Eligible participants will be asked to provide their name, address, and telephone number, so that they can be mailed a pre-program information pack containing: an information statement, informed consent form, and medical clearance form. Participants will receive one pack for each potentially interested person they nominate. Participants will be asked to complete the consent form and return these to the Project Co-ordinator. Participants who do not return these forms will receive one telephone reminder call two weeks after being sent this pack.Once the completed consent and medical clearance form have been returned, participants will be randomised to either the intervention or control group via random number table. Participants will be stratified by age and gender of the cancer survivor. If there is both a cancer survivor and partner/caregiver, they will be randomised together. The Project Co-ordinator will phone participants via telephone to enrol them in a program (intervention participants will participate in one of 3 concurrent programs available in the first half of 2010; control participants will participate in one of 3 concurrent programs running the second half of 2010). Participants will be randomly allocated to an intervention or control group, only after they have been screened for eligibility and returned a completed consent form. The allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Subjects will be stratified by age and gender. For each combination of age category (<50; 50-65, 65+) and gender, a separately generated random sequence will be generated. Excel will be used to generate random combinations of 4 (intervention & control: 2 per group). Each combination of 4 will be assigned a random number using an excel random number function. These will be sorted via excel, and each randomly generated sequence of 4 will be added to the stratified tables.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2010

Actual

27/01/2010

Date of last participant enrolment

Anticipated

Actual

24/04/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

174

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2011

Recruitment postcode(s) [2]

2031

Recruitment postcode(s) [3]

2067

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government, Department of Health and Ageing

Address [1]

Integration and Self-Management Section (MDP 4), GPO Box 9848, Canberra ACT 2601.

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University of Newcastle,
Callaghan Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Cancer Council NSW

Address [1]

153 Dowling St, Woolloomooloo NSW 2011

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee,
Research Office,
East Wing, The Chancellery
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/11/2009

Ethics approval number [1]

H-2009-0347

Ethics committee name [2]

The University of New South Wales Human Research Ethics Committee.

Ethics committee address [2]

Rupert Myers Building, C/o Research Office/Ethics, Gate 14, Barker Street, Kensington NSW 2052

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

09/11/2010

Ethics approval number [2]

HREC 10387

Summary

Brief summary

The study will determine the efficacy of an 8 week (x 6 session) face-to-face education and skill development program targeting the self-management of nutrition, physical activity and healthy weight management for cancer survivors who have finished active cancer treatment, and their partners/caregivers.

Trial website

Trial related presentations / publications

James EL, Stacey FG, Chapman K, Boyes AW, Burrows T, Girgis A, Asprey G, Bisquera A, Lubans DR. Impact of a nutrition and physical activity intervention (ENRICH: Exercise and Nutrition Routine Improving Cancer Health) on health behaviors of cancer survivors and carers: a pragmatic randomized controlled trial. BMC Cancer., 2015: 15: 710. DOI 10.1186/s12885-015-1775-y

James EL, Stacey F, Chapman K, Lubans DR, Asprey G, Sundquist K, Boyes A, Girgis A. Exercise and Nutrition Routine Improving Cancer Health (ENRICH): The protocol for a randomized efficacy trial of a nutrition and physical activity program for adult cancer survivors and carers. BMC Public Health, 2011 11, art. No. 236.

Asprey G, Stacey F, Miller A, James E, Chapman K, Lubans D, Boyes A. Recruitment of cancer survivors and carers to a face-to-face lifestyle intervention: balancing methodological considerations and logistical challenges. Flinders Centre for Innovation in Cancer (FCIC) Survivorship Conference, 1-3 February 2013 (poster), Adelaide Australia.

Chapman K, James E, Stacey F, Asprey G, Lubans D, Boyes A, Girgis A. Efficacy of a lifestyle intervention for cancer survivors and carers: Do participants change their diet and if so how?” 11th Behavioural Research in Cancer Control (BRCC) Conference, 8-10 May 2013, Adelaide Australia.

Stacey FG, James EL, Chapman K, Lubans DR, Asprey G, Boyes A, Girgis A. How to develop, implement, and evaluate a theory-based nutrition and physical activity program for cancer survivors and carers: the ENRICH (exercise and nutrition routine improving cancer health) program example. 2013 Annual Meeting of the International Society for Behavioural Nutrition and Physical Activity, 22-25 May 2013. (as part of symposium “Behavioural nutrition and physical activity in the prevention and management of cancer – an understudied area”). Ghent, Belgium.

Stacey F, Lubans DR, James EL, Chapman K, Asprey G. Exploring potential mediators of physical activity behaviour change in the ENRICH lifestyle intervention for cancer survivors and carers. 2011 Annual Meeting of the International Society for Behavioral Nutrition and Physical Activity, 15-18 June 2011, Melbourne, Australia.

Stacey F, James EL, Chapman K, Lubans DR, Asprey G, Sundquist K, Boyes A, Girgis A. ENRICH (Exercise and Nutrition Routine Improving Cancer Health): Efficacy and feasibility of an exercise and nutrition program for cancer survivors and carers. Asia-Pacific Journal of Clinical Oncology, Washington, DC (2010).

Stacey F, James E, Chapman K, Lubans D, Asprey G, Sundquist K, Boyes A, Girgis A. ENRICH (Exercise and Nutrition Routine Improving Cancer Health): Efficacy and feasibility of an exercise program for cancer survivors and carers. Clinical Oncological Society of Australia. 11th November 2010, Melbourne VIC.

James E, Chapman K, Stacey F, Asprey G, Lubans D, Sundquist K, Boyes A, Girgis A. Description and preliminary evaluation of the ENRICH (Exercise and Nutrition Routine Improving Cancer Health) Program. 10th Behavioural Research in Cancer Control Conference, 14-16 April 2010, Perth Australia.

Public notes

Contacts

Principal investigator

Name

A/Prof Erica James

Address

Level 4 West, SMPH, HMRI Building Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0562

Fax

erica.james@newcastle.edu.au

Contact person for public queries

Name

Ms Ms Gabrielle Asprey

Address

153 Dowling St,
Woolloomooloo NSW 2011.

Country

Australia

Phone

+61 2 9334 1772

Fax

+61 2 8302 3520

gabriellea@nswcc.org.au

Contact person for scientific queries

Name

A/Prof Associate Professor Erica James

Address

Level 4 West, SMPH,
HMRI Building
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0562

Fax

Erica.james@newcastle.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Trial Review

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