None listed
Conditions
Interventions
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 int
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.
Sponsors
Cathie Pigott
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed