Trial Review

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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] 1212 0
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 256426 0
Condition category
Condition code
Diet and Nutrition 256598 256598 0 0
Other diet and nutrition disorders
Public Health 256599 256599 0 0
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] 255721 0
Lifestyle
Intervention code [2] 255722 0
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] 257485 0
physical activity levels measured by the Active Australia survey
Timepoint [1] 257485 0
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] 257486 0
1 week of self-reported step counts, measured by pedometer
Timepoint [2] 257486 0
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] 257487 0
fruit and vegetable intake measured by the Diet Questionnaire for Epidemiological Studiesv2
Timepoint [3] 257487 0
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 [4] 257488 0
self-reported body mass index
Timepoint [4] 257488 0
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 [5] 257489 0
self-reported waist circumference
Timepoint [5] 257489 0
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 [1] 262681 0
social support levels measured by Medical Outcomes Study (MOS) Social Support Survey
Timepoint [1] 262681 0
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 [2] 262682 0
quality of life measured by Medical Outcomes Study Short Form survey (SF)-12
Timepoint [2] 262682 0
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] 262683 0
Mediators of physical activity changes based on Social Cognitive Theory (behavioural goal; self-efficacy; positive outcome expectations; impediments; social support)
Timepoint [3] 262683 0
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 [4] 266475 0
physical activity levels measured by the Active Australia survey
Timepoint [4] 266475 0
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 [5] 266476 0
fruit and vegetable intake measured by the Diet Questionnaire for Epidemiological Studiesv2
Timepoint [5] 266476 0
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 [6] 266477 0
self-reported body mass index
Timepoint [6] 266477 0
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 [7] 266478 0
self-reported waist circumference
Timepoint [7] 266478 0
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

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] 2368 0
2067
Recruitment postcode(s) [2] 2369 0
2011
Recruitment postcode(s) [3] 3483 0
2031

Funding & Sponsors
Funding source category [1] 256193 0
Government body
Name [1] 256193 0
Australian Government, Department of Health and Ageing
Country [1] 256193 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle,
Callaghan Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 251537 0
Charities/Societies/Foundations
Name [1] 251537 0
Cancer Council NSW
Address [1] 251537 0
153 Dowling St, Woolloomooloo NSW 2011
Country [1] 251537 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258299 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 258299 0
Ethics committee country [1] 258299 0
Australia
Date submitted for ethics approval [1] 258299 0
Approval date [1] 258299 0
25/11/2009
Ethics approval number [1] 258299 0
H-2009-0347
Ethics committee name [2] 260120 0
The University of New South Wales Human Research Ethics Committee.
Ethics committee address [2] 260120 0
Ethics committee country [2] 260120 0
Australia
Date submitted for ethics approval [2] 260120 0
Approval date [2] 260120 0
09/11/2010
Ethics approval number [2] 260120 0
HREC 10387

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30633 0
A/Prof Erica James
Address 30633 0
Level 4 West, SMPH, HMRI Building Callaghan NSW 2308
Country 30633 0
Australia
Phone 30633 0
+61 2 4042 0562
Fax 30633 0
Email 30633 0
[email protected]
Contact person for public queries
Name 13880 0
Ms Gabrielle Asprey
Address 13880 0
153 Dowling St,
Woolloomooloo NSW 2011.
Country 13880 0
Australia
Phone 13880 0
+61 2 9334 1772
Fax 13880 0
+61 2 8302 3520
Email 13880 0
[email protected]
Contact person for scientific queries
Name 4808 0
Associate Professor Erica James
Address 4808 0
Level 4 West, SMPH,
HMRI Building
Callaghan NSW 2308
Country 4808 0
Australia
Phone 4808 0
+61 2 4042 0562
Fax 4808 0
Email 4808 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.