Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
psychosocial effects of cancer and its treatment, pain, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer. It is not yet known whether reflexology is more effective than aromatherapy massage in relieving symptoms in patients with cancer. PURPOSE: This randomized clinical trial is studying reflexology to see how well it works compared with aromatherapy massage in relieving symptoms in patients with cancer.
Detailed description
OBJECTIVES: Primary * To determine whether reflexology is as effective as aromatherapy massage for alleviation of self-selected symptoms in patients with cancer in an outpatient setting. Secondary * To determine the difference between the two therapies with respect to Visual Analogue Scale (VAS) relaxation scores before and after each treatment. OUTLINE: Patients are stratified according to gender (male vs female), treatment (chemotherapy vs other) and their first concern choice (pain vs other). Patients are randomized to 1 of 2 intervention arms. * Arm I (Reflexology): Patients undergo 45-60 minutes of reflexology for 4 sessions. * Arm II (Aromatherapy massage): Patients undergo 45-60 minutes of of aromatherapy massage for 4 sessions. Patients complete questionnaires (Measure Yourself Concerns and Well-being \[MYCAW\] questionnaire and Visual Analogue Scale \[VAS\]) at baseline, before and after each session, and after completion of all four sessions.
Interventions
OTHERquestionnaire administration
PROCEDUREaromatherapy and essential oils
PROCEDUREmanagement of therapy complications
PROCEDUREmassage therapy
PROCEDUREpsychosocial assessment and care
PROCEDUREreflexology procedure
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Any patient receiving treatment for cancer at the Royal Marsden NHS Foundation Trust Hospital * Must be attending the hospital as an outpatient * Planning to access complementary therapy PATIENT CHARACTERISTICS: * No excessive pain in both hands and both feet * Not experiencing a combination of conditions affecting both hands and both feet which would prevent reflexology of either hands or feet from taking place, including any of the following: * Deep vein thrombosis * Lymphedema * Infected or broken skin * Recent scars or injuries * Phlebitis * Areas currently receiving radiotherapy (or received radiotherapy in the past 2 weeks) * Able and willing to attend the hospital for four 1-hour sessions PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 months since prior and no other concurrent massage therapy or reflexology at the Royal Marsden NHS Foundation Trust Hospital or from another practitioner * Not planning to undergo massage therapy or reflexology while also taking part in this study * At least 2 months since prior and no other concurrent massage therapy at the Royal Marsden NHS Foundation Trust Hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of 1 point of concern scores in Measure Yourself Concerns and Well-being (MYCAW) questionnaire from baseline to second evaluation (after completion of all four sessions of therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of 2 points of concern scores in MYCAW questionnaire | — |
| Difference in MYCAW overall well-being score | — |
| Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit) | — |
| Change in pre- to post-session VAS relaxation score (short-term relaxation benefit) | — |
| Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales | — |
Countries
United Kingdom
Outcome results
None listed