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Trial registered on ANZCTR


Registration number
ACTRN12614000113651
Ethics application status
Approved
Date submitted
16/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination of the physical and psychological benefits of a home-based physical activity programme (The Man Plan) for prostate cancer survivors on androgen deprivation therapy
Scientific title
An examination of the efficacy of the man plan physical activity programme for prostate cancer survivors on androgen deprivation therapy
Secondary ID [1] 283923 0
Nil known.
Universal Trial Number (UTN)
U1111-1150-4280
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 290923 0
Fatigue 290924 0
Sexual Health 290925 0
Physical activity 290926 0
Condition category
Condition code
Diet and Nutrition 291279 291279 0 0
Other diet and nutrition disorders
Cancer 291325 291325 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.To compare changes in physical activity, fatigue, quality of life (QoL), self-efficacy, sexual interest/function and diet and nutrition for prostate cancer survivors on androgen depravation therapy (PCa-ADT) participating in the Man Plan programme compared to PCa-ADT survivors undergoing usual care (i.e., no physical activity). The Man Plan programme is a physical activity programme designed for prostate cancer survivors on ADT treatment. The Man Plan consists of an instructional DVD, which goes through a series of exercises, which includes the use of resistance bands. The men are encouraged to engage in these physical activities on a regular daily basis. Each participant enrolled in the Man Plan component will be told to engage in the physical activities for a 20 minute period each day. With the exception of the physical activity measure (administered at three time points) and the focus group interviews (at three time points for a sub-group of participants) no strategies will be used to monitor adherence to the intervention. Each participant will enrolled in the study over a 12 month period.
Intervention code [1] 288611 0
Lifestyle
Intervention code [2] 288612 0
Behaviour
Comparator / control treatment
Measures will be administered to both groups (intervention and control group) at three times points during the 12-month study period. Control participants will not be participating in the Man Plan physical activity programme. Control participants will receive usual care treatment which does not include engaging in a physical activity programme, or specific advice for regular physical activity engagement.
Control group
Active

Outcomes
Primary outcome [1] 291280 0
Physical activity will be assessed by the Rapid Assessment of Physical Activity questionnaire (RAPA).
Timepoint [1] 291280 0
The RAPA will be administered at three time points: baseline, 6 months post-baseline and at 12-months post-baseline.
Secondary outcome [1] 306412 0
Fatigue will be assessed by the Brief Fatigue Inventory (BFI).
Timepoint [1] 306412 0
The BFI will be administered at three time points: baseline, 6 months post baseline and at 12 months post baseline.
Secondary outcome [2] 306413 0
Self-efficacy will be assessed by a questionnaire that was constructed for the present study comprising of questions from three existing, validated measures. Questions will focus on behaviour, diet and nutrition and physical activity.
Timepoint [2] 306413 0
The Self-Efficacy questionnaire will be administered at three time points: baseline, 6 months post-baseline and at 12 months post-baseline.
Secondary outcome [3] 306414 0
Quality of Life will be assessed by the New Zealand version of the WHO Quality of Life-BREF (NZ WHOQOL-BREF).
Timepoint [3] 306414 0
The NZ WHOQOL-BREF will be administered at three time points: baseline, 6 months post-baseline and at 12 months post-baseline.
Secondary outcome [4] 306415 0
Sexual health will be assessed by the European Organization for Research and Treatment of Cancer Prostate Cancer-Specific Quality of Life Questionnaire (EORTC P25).
Timepoint [4] 306415 0
The EORTC P25 will be administered at three time points: baseline, 6 months post-baseline and at 12 months post-baseline.
Secondary outcome [5] 306416 0
Diet will be assessed by the Food and Nutrition Questionnaire. This questionnaire was constructed for this study and comprises of questions modified from the 2008/9 New Zealand Adults Nutrition Survey Questionnaire carried out by the New Zealand Ministry of Health.
Timepoint [5] 306416 0
The Food and Nutrition Questionnaire will be administered at three time points: baseline, 6 months post-baseline and at 12 months post-baseline.

Eligibility
Key inclusion criteria
Inclusion criteria: the individual is a PCa survivor receiving the androgen deprivation therapy (ADT) treatment of Lucrin.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The individual is a PCa survivor who is receiving the ADT treatment of Lucrin, but is also receiving chemotherapy treatment. This type of treatment can increase fatigue and decrease ability to engage in regular physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once ethical approval is obtained, the recruitment process will begin. Participants will be recruited through their clinician's, with Abbvie (pharmaceutical company) contacting on our behalf the urologists and other clinicians throughout the country who prescribe Lucrin. Potential participants identified by each clinician will then be mailed a Letter of Invitation, an Information Sheet and a Consent Form with a reply paid envelope in which to return their completed Consent Form if they consent to participate in the study. Potential participants will be given a 2 week period in which to return their Consent Forms. After this time one follow up phone call will be made, first to ascertain that they received information regarding the study and secondly to ascertain if they agree to take part in the study.

Once a participant has given consent to take part in the study the enrollment process will begin. Participants will be randomly allocated to either the intervention or control group based on the order in which they enroll (i.e., participant one will be allocated to the intervention group, participant two will be allocated to the control group). Allocation will be carried by central randomisation by a computer generated list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the intervention or control group based on the order in which they enroll (i.e., participant one will be allocated to the intervention group, participant two will be allocated to the control group). Allocation will be carried out by central randomisation via computer generated list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Please note that three focus groups will also be carried out with some intervention participants and individual interviews will be carried out with some clinicians. Three focus groups ideally involving the same group of 8-10 intervention group participants will be conducted in line with the quantitative assessments.
Individual face-to-face interviews involving 10-15 clinicians (i.e. urologists, general practitioners or oncologists) who prescribe Lucrin will be conducted during the first 18 months of the study to gain a better understanding of the factors influencing the clinicians’ promotion of the Man Plan to their patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A one-way repeated measures of analysis of variance (ANOVA) will be carried out to examine whether any significant changes in physical activity, fatigue, QOL, self-efficacy and sexual health scores occur over the three time points (baseline, 6 months post-baseline and 12 months post-baseline) for participants in both groups. One hundred PCa-ADT survivors will take part in the main quantitative component. This number of participants (n=100) meets statistical assumptions for effect size calculations and for conducting post-hoc tests for significance (Pallant, 2013). Previous physical activity interventions that have been carried out with prostate cancer survivors have had similar sample sizes that showed a clinically relevant effect (Culos-Reed et al., 2010; Zahavich et al., 2013).


Qualitative analysis: An inductive thematic approach to analyse themes that emerge regarding the benefits and barriers of the physical activity programme, issues around fatigue, quality of life, self-efficacy and sexual health. It is envisioned that by carrying out each focus group at three time points within the study period with the same group of participants will help provide information regarding the perceived benefits and barriers that the physical activity programme had on their physical and psychological health status and other/related issues that cannot be ascertained by set questionnaires. Eight to ten intervention participants will participate in the focus groups.
Ten to fifteen clinicians who prescribe Lucrin and/or endorse the Man Plan programme and/or treat PCa patients and survivors will also be individually interviewed regarding their views on physical activity for PCa-ADT patients and the role of the Man Plan programme.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
30/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5749 0
New Zealand
State/province [1] 5749 0

Funding & Sponsors
Funding source category [1] 288562 0
Charities/Societies/Foundations
Name [1] 288562 0
New Zealand Cancer Society
Country [1] 288562 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand Cancer Society
Address
Level 2 Red Cross House
69 Molesworth Street
Wellington 6144
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287276 0
None
Name [1] 287276 0
Address [1] 287276 0
Country [1] 287276 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
An intervention study involving two groups: an intervention group and a control group. Group 1 will consist of 50 PCa participants undertaking the Man Plan programme and group 2 will consist of 50 control PCa participants who do not participate in the Man Plan programme (usual care group) as advice on physical activity is not currently a part of usual care for PCa-ADT patients in New Zealand. Both groups of participants will be on ADT treatment of Lucrin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45634 0
Dr Asmita Patel
Address 45634 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 45634 0
New Zealand
Phone 45634 0
64 021 178 6485
Fax 45634 0
64 9 9219960
Email 45634 0
[email protected]
Contact person for public queries
Name 45635 0
Grant Schofield
Address 45635 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 45635 0
New Zealand
Phone 45635 0
64 9 9219169
Fax 45635 0
64 9 9219746
Email 45635 0
[email protected]
Contact person for scientific queries
Name 45636 0
Justin Keogh
Address 45636 0
Bond University
14 University Drive
Robina
Queensland 4226
Country 45636 0
Australia
Phone 45636 0
61 7 5595 4487
Fax 45636 0
61 7 5595 4480
Email 45636 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

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