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Trial registered on ANZCTR


Registration number
ACTRN12605000724673
Ethics application status
Approved
Date submitted
10/11/2005
Date registered
11/11/2005
Date last updated
10/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to examine whether an intervention that includes foot massage has any effect on the experience of nausea and vomiting following chemotherapy received by cancer patients in the ambulatory care setting.
Scientific title
A pilot study to examine whether an intervention that includes foot massage has any effect on the experience of nausea and vomiting following chemotherapy received by cancer patients in the ambulatory care setting.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 875 0
Condition category
Condition code
Alternative and Complementary Medicine 943 943 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot randomised unblinded cross-over trial of control (usual care) versus intervention (addition of foot massage) for nausea and vomiting in cancer patients undergoing chemotherapy. As this study is a cross-over design all patients will receive both the intervention and usual care. Participants allocated to Arm 1 will receive usual care first and the intervention second, participants allocated to Arm 2 will receive the intervention first and then the usual care. The foot massage intervention of 15 minutes will involve using slow firm or gentle strokes toward the heart from the base of the toes to the ankle area. The fingertips will be used to make small circular movements around joints and between deep and superficial muscles, including the ankle, and between the metatarsals. A rhythmic lifting and squeezing of the flesh using both hands will be alternated with the other movements. Sorbolene cream with 10% glycerol (Hydraderm) will be used as the lubricant; this cream is readily available on the ward and is not perfumed. The interaction between the masseur and the participant will be considered to be a part of the intervention. It would be difficult to provide massage without interacting with the participant, and it is recognized that the effect of massage as a form of touch is unlikely to be distinguishable from the relationship with the participant. Patients must have at least one week between chemotherapy courses. Usual care is defined as the care received by patients attending the day chemotherapy ward which will involve no interaction with the pastoral care worker who is providing the intervention. Participants will receive the foot massage prior to receiving the chemotherapy treatment.
Intervention code [1] 755 0
None
Comparator / control treatment
The control treatment is usual care.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1239 0
This pilot research project seeks to identify whether an intervention that includes a foot massage, given for 15 minutes prior to treatment of patients having moderate to high emetogenic chemotherapy has an effect on the experience of nausea and vomiting in the ambulatory setting. Nausea and vomiting will be measured using the Chemotherapy Symptom Assessment Scale as well as a numerical rating scale for nausea (0 no nausea-10worst possible nausea) and a frequency of vomiting question.
Timepoint [1] 1239 0
72-96 hours post chemotherapy
Primary outcome [2] 1241 0
To determine the effect the intervention of foot massage has on the occurrence, severity and distress of vomiting in cancer patients undergoing chemotherapy. Distress of nausea and vomiting will be measured using the Chemotherapy Symptom Assessment Scale.
Timepoint [2] 1241 0
72-96 hours post chemotherapy
Secondary outcome [1] 2259 0
To determine if there is any association between baseline distress score (using the Distress thermometer) and subsequent nausea and vomiting experience in cancer patients undergoing chemotherapy measured at 72-96 hours post chemotherapy.
Timepoint [1] 2259 0
Pre-chemotherapy and
72-96 hours post chemotherapy

Eligibility
Key inclusion criteria
To be eligible for the study, patients must be receiving chemotherapy in the ambulatory setting and: 1)Be receiving a chemotherapy that is moderately or highly emetogenic (Class III or IV) as listed in the guidelines for antiemetics for chemotherapy-induced emesis in adults; 2)Receiving at least the second course of chemotherapy and planned to receive at least 1 further cycle of the regimen at least one week apart; 3) Able to speak, read and write English sufficiently well to participate in the data collection process; 4)agree to data extraction from their medical record; 5)Have experienced nausea and/or vomiting since having chemotherapy.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Are under the care of a psychiatrist
2) Are scheduled to have chemotherapy as an in-patient treatment in the next 48 hours;
3) Are receiving chemotherapy treatment delivered as an in-patient;
4) Have a poor clinical performance status (ECOG > 2);
5) Have an open skin wounds on their feet;
6) Have a foot tumour or foot metastasis, or radiation treatment to the feet.
7) Have peripheral vascular disease
8) Have lymphatic or venous occlusion / obstruction affecting the lower limbs.

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)
The adaptive biased coin procedure will take place prior to commencement of the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following confirmation of eligibility patients will be randomly allocated in an approximately 1:1 ratio to receive either control then intervention or intervention then control. The method of randomisation will be based upon an adaptive biased coin procedure. The primary researcher will inform the patient of group allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1041 0
Charities/Societies/Foundations
Name [1] 1041 0
Cancer Nurses Society Australia
Address [1] 1041 0
c/o Clinical Oncology Society of Australia
GPO Box 4708, Sydney NSW 2001
Country [1] 1041 0
Australia
Primary sponsor type
Individual
Name
Cathie Pigott
Address
Level 3 Nursing Education Peter MacCallum Cancer Centre Locked Bag 1 A'Beckett St Melbourne 8006
Country
Australia
Secondary sponsor category [1] 903 0
None
Name [1] 903 0
N/A
Address [1] 903 0
Country [1] 903 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35799 0
Address 35799 0
Country 35799 0
Phone 35799 0
Fax 35799 0
Email 35799 0
Contact person for public queries
Name 9944 0
Cathie Pigott
Address 9944 0
Peter MacCallum Cancer Centre
Level 3
Locked Bag 1
A'Beckett St
Melbourne VIC 8006
Country 9944 0
Australia
Phone 9944 0
+61 3 96563561
Fax 9944 0
Email 9944 0
cathie.pigott@petermac.org
Contact person for scientific queries
Name 872 0
Cathie Pigott
Address 872 0
Peter MacCallum Cancer Centre
Level 3
Locked Bag 1
A'Beckett St
Melbourne VIC 8006
Country 872 0
Australia
Phone 872 0
+61 3 96563561
Fax 872 0
Email 872 0
cathie.pigott@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary