PainNCT01217424
Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer
A study testing questionnaire administration, aromatherapy and essential oils and management of therapy complications in people with Pain and Psychosocial Effects of Cancer and Its Treatment, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- questionnaire administration, aromatherapy and essential oils and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?
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.
Read the 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.
- Conditions
- Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- questionnaire administration, aromatherapy and essential oils, management of therapy complications, massage therapy, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, pain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
aromatherapy and essential oilsProcedure or surgery
management of therapy complicationsProcedure or surgery
massage therapyProcedure or surgery
psychosocial assessment and careProcedure or surgery
reflexology procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Clare Shaw, MD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217424
- Sponsor's protocol ID
- CDR0000686459
- Other IDs
- RMNHS-REFLEXOLOGY, EU-21075, MREC-10/H0801/31
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?
- ClinicalTrials.gov ID
- NCT01217424
- Acronym / sponsor ID
- CDR0000686459
- Conditions
- Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- psychosocial effects of cancer and its treatment, pain, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| aromatherapy and essential oils | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| massage therapy | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| reflexology procedure | Procedure or surgery | – |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Shaw, MD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, aromatherapy and essential oils and management of therapy complications in people with Pain and Psychosocial Effects of Cancer and Its Treatment, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.