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Trial registered on ANZCTR


Registration number
ACTRN12620000119998
Ethics application status
Approved
Date submitted
25/01/2020
Date registered
7/02/2020
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess the feasibility and role of therapeutic massage for cancer patients receiving outpatient chemotherapy at Lakes District Health Board
Scientific title
A pilot study to assess the feasibility and role of therapeutic massage for cancer patients receiving outpatient chemotherapy at Lakes District Health Board
Secondary ID [1] 300364 0
UTN: U1111-1239-8746
Universal Trial Number (UTN)
UTN: U1111-1239-8746
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 315977 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314433 314433 0 0
Other physical medicine / rehabilitation
Cancer 314442 314442 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is not applicable that there are strategies to monitor fidelity to the intervention. The massage therapist provides the intervention, namely massage to the patient who has consented for the intervention. Each patient will have the intervention only once. This is a pilot study which will assess the role and feasibility of providing therapeutic massage for cancer patients receiving outpatient chemotherapy at Lakes District Health Board, Rotorua, New Zealand. The massage areas that will be offered are forearm/hand or lower leg/feet. The massage duration will be for 15 minutes and will occur while the patient is having the chemotherapy or immunotherapy infusion. As this is a pilot all patients presenting to the chemotherapy suite ( regardless of where they are in their treatment) who meet the inclusion criteria will be offered massage. The massage will be given by a qualified massage therapist. The patient will be reassured that they can stop the massage at any point and there will be no pressure that they are recruited.
Intervention code [1] 316644 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322638 0
feasibility of providing massage
Timepoint [1] 322638 0
A feasibility checklist will be assessed each day and the results assessed following the pilot completion. The checklist includes the number of participants recruited, excluded, and those that met the inclusion criteria but declined. It will note the number of massages that were not able to be started and completed during the participant's treatment; the number of massage sessions that were stopped because of pain/discomfort or at the participant's request. It will note the mode of delivery whether it is with the patient in an armchair or bed and the massage areas that were requested by the participant. Gender, age and ethnicity of the participants will also be noted in the feasibility checklist
Primary outcome [2] 322741 0
Anxiety
Timepoint [2] 322741 0
Anxiety will be measured via The State-Trait Anxiety Inventory (STAI), immediately pre and post-massage
Primary outcome [3] 322742 0
Pain
Timepoint [3] 322742 0
Pain will be assessed using a Likert rating scale that will be done immediately pre and post-massage
Secondary outcome [1] 379523 0
Nausea
Timepoint [1] 379523 0
Nausea will be assessed using a Likert rating scale that will be done immediately pre and post-massage
Secondary outcome [2] 379676 0
Fatigue
Timepoint [2] 379676 0
Fatigue will be assessed using a Likert rating scale that will be done immediately pre and post-massage

Eligibility
Key inclusion criteria
• Able to comprehend the study procedures and given informed consent.
• Assessed by the Oncologist or their delegated authority as being suitable to participate in the pilot.
• Aged 18 years or over.
• Awake and alert during the massage therapy session
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those individuals who do not meet the inclusion criteria or deemed by the oncologist or their delegated authority as not being suitable to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
This pilot is to assess the feasibility and the role of therapeutic massage provided to patients receiving outpatient chemotherapy. No statistical analysis will be done.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22269 0
New Zealand
State/province [1] 22269 0
Rotorua

Funding & Sponsors
Funding source category [1] 304789 0
Self funded/Unfunded
Name [1] 304789 0
Address [1] 304789 0
Country [1] 304789 0
Primary sponsor type
Individual
Name
Ellen Pope
Address
Toi Ohomai Institute of Technology
Mokoia Drive
Tihiotonga
Rotorua 3015

Country
New Zealand
Secondary sponsor category [1] 305108 0
Individual
Name [1] 305108 0
Jackie Blue
Address [1] 305108 0
Lake Tarawera Health & Sports Massage
Rangiuru Bay Rd
Lake Tarawera
Rotorua 3076
Country [1] 305108 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305204 0
Northern Region Health and Disability Ethics Committee ( NZ)
Ethics committee address [1] 305204 0
Ministry of Health, PO box 5013, Wellington, New Zealand
Ethics committee country [1] 305204 0
New Zealand
Date submitted for ethics approval [1] 305204 0
09/10/2019
Approval date [1] 305204 0
10/01/2020
Ethics approval number [1] 305204 0
19/NTB/202

Summary
Brief summary
This pilot will assess the feasibility of providing a concurrent 15-minute massage to either hand/forearm or lower leg/foot to patients undergoing outpatient chemotherapy. Patients will be asked to fill in a survey immediately before and after the massage to assess anxiety, nausea, pain and fatigue. The pilot will occur over a 3 week period Feb 10th 2020 to Feb 28th 2020.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 99598 0
Ms Ellen Pope
Address 99598 0
Toi Ohomai Institute of Technology
Mokoia Drive
Tihiotonga
Rotorua 3015
Country 99598 0
New Zealand
Phone 99598 0
+64212414988
Fax 99598 0
Email 99598 0
Ellen.Pope@toiohomai.ac.nz
Contact person for public queries
Name 99599 0
Ms Ellen Pope
Address 99599 0
Toi Ohomai Institute of Technology
Mokoia Drive
Tihiotonga
Rotorua 3015
Country 99599 0
New Zealand
Phone 99599 0
+64212414988
Fax 99599 0
Email 99599 0
Ellen.Pope@toiohomai.ac.nz
Contact person for scientific queries
Name 99600 0
Ms Ellen Pope
Address 99600 0
Toi Ohomai Institute of Technology
Mokoia Drive
Tihiotonga
Rotorua 3015
Country 99600 0
New Zealand
Phone 99600 0
+64212414988
Fax 99600 0
Email 99600 0
ellenpopemt@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6599 0
Study protocol
Citation [1] 6599 0
Link [1] 6599 0
Email [1] 6599 0
ellenpopemt@gmail.com
Other [1] 6599 0
Attachment [1] 6599 0
Type [2] 6600 0
Informed consent form
Citation [2] 6600 0
Link [2] 6600 0
Email [2] 6600 0
ellenpopemt@gamil.com
Other [2] 6600 0
Attachment [2] 6600 0
Type [3] 6601 0
Ethical approval
Citation [3] 6601 0
Link [3] 6601 0
Email [3] 6601 0
ellenpopemt@gmail.com
Other [3] 6601 0
Attachment [3] 6601 0
Type [4] 6602 0
Clinical study report
Citation [4] 6602 0
Link [4] 6602 0
Email [4] 6602 0
ellenpopemt@gmail.com
Other [4] 6602 0
Attachment [4] 6602 0
Summary results
No Results