Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001079437
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
11/08/2016
Date last updated
27/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The addition of motivational interviewing to an oncology rehabilitation program: A randomised controlled trial
Scientific title
The addition of motivational interviewing to an oncology rehabilitation program to improve physical activity: A randomised controlled trial
Secondary ID [1] 289829 0
Nil
Universal Trial Number (UTN)
U1111-1185-9906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 299756 0
Condition category
Condition code
Cancer 299690 299690 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational Interviewing + Oncology Rehabilitation Program
The motivational interviewing group will receive weekly half hour telephone calls for 7 weeks in addition to their rehabilitation program. These calls will be aimed at promoting physical activity using a motivational interviewing style whereby the therapist guides the patient to come up with their own reasons for changing physical activity behaviour. Telephone calls will be individually tailored to each patient. The motivational interviewing will be conducted by a physiotherapist who has completed a 2 day group workshop in motivational interviewing run by a psychologist. They also will receive a minimum of 6, 1 hour individual coaching sessions by a motivational interviewing specialist. The proficiency of the physiotherapist in delivering motivational interviewing will be assessed on two occasions based on a role play by an independent assessor using the validated Motivational Interviewing Treatment Integrity Scale version 4.1: once prior to the commencement of the intervention and once during the mid-point of the intervention. Adherence to telephone calls will be monitored through call log records of duration and topics covered by the therapist within each session.
All participants will receive 1 hour of exercise and 1 hour of education as
part of their usual rehabilitation program which will run twice weekly for 7 weeks. They will also receive a home exercise program and diary as per the control group.
Intervention code [1] 295505 0
Rehabilitation
Intervention code [2] 295523 0
Behaviour
Comparator / control treatment
The comparison group will receive 1 hour of exercise and 1 hour of education as part of a standard oncology rehabilitation program which will run twice weekly for 7 weeks. They will also receive a personalised written or video home exercise program and diary.
The rehabilitation program will be completed in a group format with exercise individually tailored to each patient. Exercise will consist of aerobic, resistance balance and flexibility training and progressed according to an established protocol.
The education program will follow the exercise sessions and will run for 1 hour each session. The group education sessions will provide information about topics related to coping with a cancer diagnosis and management of cancer as a chronic disease.
The rehabilitation program will be run by a oncology trained nurse, physiotherapist and allied health assistant. A social worker, occupational therapist and dietician will also provide relevant education sessions.
Control group
Active

Outcomes
Primary outcome [1] 299151 0
Physical Activity. The amount of moderate physical activity completed in 10 minute bouts will be derived from the ActivPAL data using customized software based on a cut point of 100 steps per minute to define moderate intensity. ActivPAL monitors will be worn continuously for 7 days pre and post intervention, with data from full 24 hour days being used for analysis.
Timepoint [1] 299151 0
Post Intervention - Week 8
Secondary outcome [1] 326332 0
Inflammation. Blood samples will be taken to measure C-reactive Protein using standard techniques
Timepoint [1] 326332 0
Post Intervention-Week 8
Secondary outcome [2] 326333 0
Fatigue using the Brief Fatigue Inventory
Timepoint [2] 326333 0
Post-Intervention - Week 8
Secondary outcome [3] 326334 0
Quality of life using the European Organization for Research and Treatment of Cancer QoL Questionnaire-C30
Timepoint [3] 326334 0
Post-Intervention - Week 8
Secondary outcome [4] 326335 0
Depression and anxiety using Hospital Anxiety and Depression Scale
Timepoint [4] 326335 0
Post Intervention- week 8
Secondary outcome [5] 326336 0
Physical Performance -Karnofsky Performance Scale
Timepoint [5] 326336 0
Post Intervention- week 8
Secondary outcome [6] 326337 0
Walking Capacity - 6 minute walk test
Timepoint [6] 326337 0
Post Intervention - week 8
Secondary outcome [7] 326338 0
Lower limb muscle performance using the five repetition Sit to Stand test
Timepoint [7] 326338 0
Post Intervention- week 8
Secondary outcome [8] 326339 0
Upper limb muscle performance using handgrip dynamometer (Jamar Registered Trademark, Patterson Medical, IL, USA)
Timepoint [8] 326339 0
Post Intervention- week 8
Secondary outcome [9] 326376 0
experiences of oncology rehabilitation with and without motivational interviewing completed through semi-structured interviews
Timepoint [9] 326376 0
Post Intervention - week 8

Eligibility
Key inclusion criteria
Participants referred to rehabilitation who are aged 18 years and over; have a diagnosis of cancer; can speak conversational English; are undergoing treatment or have completed adjuvant therapy in the last 12 months (except for long term oral hormonal therapies); and are able to give written informed consent. Cognition will be screened prior to assessment using the Short Portable Mental Status Questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a medical condition that contraindicates participation in an exercise based rehabilitation program as assessed by a medical practitioner prior to commencement of the rehabilitation program; are more than 12 months post cessation of treatment; are receiving end of life care (estimated <3 months to live); have high levels of psychological distress on screening assessment as measured by the Kessler 10 questionnaire (K10) with a score of >29; are already meeting physical activity guidelines (achieving 150 minutes of moderate intensity activity, accumulated in at least 10 minute bouts, per week).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Assignments will be placed in opaque, sealed envelopes prior to study commencement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software www.randomization.com. Randomisation will be stratified by treatment status, and tumour stream at baseline. Four strata will be created which will include: treatment/solid tumour, treatment/haematological malignancy, post-treatment/solid tumour, post-treatment/haematological malignancy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of co-variance (ANCOVA) will be used to determine the effect of the intervention on primary and secondary outcomes of amount of moderate to vigorous physical activity (minutes), sedentary time (minutes), step count, levels of inflammation, fatigue, mood, quality of life, self-efficacy, strength, and walking capacity. Group means between groups at Week 8 will be compared using baseline scores as covariates. All available data will be analysed as per group allocation in accordance with the intention to treat principle.
To compare the amount of people meeting recommended physical activity guidelines (150 minutes of moderate to vigorous physical activity achieved with and without bouts), numbers and percentages of participants meeting guidelines will be recorded at baseline and week 8 and odds ratios will be calculated through logistic regression. Any differences at baseline will be adjusted through logistic regression using baseline proportions and group allocation as independent variables.
A minimum sample size of 38 has been calculated to be sufficient for power of 0.80 and two-tailed alpha level of 0.05 to detect a large standardised mean difference of 0.97 based on the assumption that moderate to vigorous physical activity levels of patients enrolled for oncology rehabilitation in the intervention group would increase from 12.2 minutes per day to 21 minutes per day (150 minutes per week) in order to achieve physical activity guidelines. To account for 20% attrition, 46 participants will be recruited.
Qualitative analysis will also be completed to explore differences between the motivational interviewing and standard rehabilitation groups to gain a deeper understanding about patient perspectives about their experience with the Oncology Rehabilitation Program. Participants for the qualitative phase of the study will be recruited through purposive sampling, and invited to complete a 20 to 30 minute interview at the completion of the rehabilitation program. Approximately 20 participants (10 per group) will be selected or until data saturation, that is a sufficient number of participants have been interviewed with no new themes occurring.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2016
Actual
19/08/2016
Date of last participant enrolment
Anticipated
21/11/2017
Actual
26/09/2017
Date of last data collection
Anticipated
26/12/2017
Actual
21/11/2017
Sample size
Target
46
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6354 0
Wantirna Health - Wantirna
Recruitment postcode(s) [1] 13900 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 294209 0
Hospital
Name [1] 294209 0
Eastern Health
Country [1] 294209 0
Australia
Funding source category [2] 294210 0
University
Name [2] 294210 0
La Trobe University
Country [2] 294210 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora
Victoria
3083
Country
Australia
Secondary sponsor category [1] 293044 0
Hospital
Name [1] 293044 0
Eastern Health
Address [1] 293044 0
5 Arnold St
Box Hill
Victoria
3128
Country [1] 293044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295618 0
Eastern Health
Ethics committee address [1] 295618 0
Ethics committee country [1] 295618 0
Australia
Date submitted for ethics approval [1] 295618 0
22/06/2016
Approval date [1] 295618 0
09/08/2016
Ethics approval number [1] 295618 0
E14/2016
Ethics committee name [2] 295737 0
La Trobe University
Ethics committee address [2] 295737 0
Ethics committee country [2] 295737 0
Australia
Date submitted for ethics approval [2] 295737 0
10/08/2016
Approval date [2] 295737 0
12/08/2016
Ethics approval number [2] 295737 0
E14/2016

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

Contacts
Principal investigator
Name 67966 0
Prof Nicholas Taylor
Address 67966 0
Allied Health Clinical Research Office
Eastern Health
5 Arnold St
Box Hill
VIC
3128
Country 67966 0
Australia
Phone 67966 0
+61 3 9091 8874
Fax 67966 0
Email 67966 0
[email protected]
Contact person for public queries
Name 67967 0
Amy Dennett
Address 67967 0
Allied Health Clinical Research Office
Eastern Health
5 Arnold St
Box Hill
VIC
3128
Country 67967 0
Australia
Phone 67967 0
+61 3 9095 2442
Fax 67967 0
Email 67967 0
[email protected]
Contact person for scientific queries
Name 67968 0
Amy Dennett
Address 67968 0
Allied Health Clinical Research Office
Eastern Health
5 Arnold St
Box Hill
VIC
3128
Country 67968 0
Australia
Phone 67968 0
+61 3 9095 2442
Fax 67968 0
Email 67968 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
SourceTitleYear of PublicationDOI
EmbaseMotivational interviewing added to oncology rehabilitation did not improve moderate-intensity physical activity in cancer survivors: a randomised trial.2018https://dx.doi.org/10.1016/j.jphys.2018.08.003
N.B. These documents automatically identified may not have been verified by the study sponsor.