Study Note
Brief summary
In this study, 18 nursing home residents who had already completed cancer treatment were randomly divided into two arms. One arm first received Swedish massage of the lower extremities for four weeks and then reflex therapy of the lower extremities for four weeks. The other arm also received both therapies, but in a different order. Both arms were systematically assessed for their mood and asked about their pain. Although the experimental setup corresponds to a crossover design, the statistical analysis is not presented in a comprehensible manner and was carried out incorrectly. It is not explained when exactly the data was collected and how the data for the individual treatments was added together, and an incorrect statistical test was used. No conclusions can therefore be drawn from this study.
In dieser Studie wurden 18 Pflegeheimbewohner mit bereits abgeschlossener Krebsbehandlung zufällig in zwei Arme eingeteilt. Der eine Arm hat zuerst über vier Wochen eine schwedische Massage der unteren Extremitäten bekommen und dann über vier Wochen eine Reflextherapie der unteren Extremitäten. Der andere Arm hat ebenso beide Therapien erhalten, aber in anderer Reihenfolge. Beide Arme sind nach einem systematischen Vorgehen in ihrer Stimmungslage eingeschätzt worden und nach ihren Schmerzen befragt worden. Obwohl der Versuchsaufbau einem Crossover-Design entspricht, ist die statistische Auswertung nicht nachvollziehbar dargestellt und fehlerhaft durchgeführt. Es wird nicht erklärt, wann genau die Daten erhoben worden sind und wie die Daten zu den einzelnen Behandlungen zusammengerechnet wurden und es wurde ein falscher statistischer Test verwendet. Es lassen sich daher keine Schlüsse aus dieser Studie ziehen.
Study Design
| Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies
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Prospective
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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Multicentric
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| Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties
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Single
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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Yes
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| Number of arms
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2
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Study characteristics
| Inclusion criteria
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Residents of the nursing home for at least 6 months, aged 75 or over, diagnosed with a solid tumor (lung, prostate,colorectal, breast) in the last 5 years, completed cancertreatments, and capable of giving informed consent, or had an acceptable surrogate capable of giving consenton the subjects behalf.
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| Exclusion criteria
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Evidence of rapid terminal decline, recent traumatic injury, or hospitalization within the 2 weeks, skin diseases: acute psoriasis, eczema, severe bruises, skin infection or ulceration, open wound, recent burn or fracture, inflammatory conditions: acute rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Reiter’s syndrome, cardiovascular conditions: history of deep vein thrombosis, phlebitis, angina, a pacemaker, recent discontinuation(less than 2 weeks) of physiotherapy that included massagetherapy, fever (recent temperature >102◦within past 24hours), or currently prescribed anticoagulant medication (e.g., Coumadin, Heparin, or derivative substances).
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| N randomized
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18
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| Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.
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NI
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| Specifications on analyses
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Paired t-test
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| Countries of data collection
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United States
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| LoE Level of evidence
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2b Oxford 2009
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| Outcome timeline Data collection times
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T0: Early morning, 7-7:30 am;
T1: mid morning, 11-11:30 am;
T2: Early afternoon, 1-1:30 pm;
T3: late afternoon, 4-4:30 pm
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Characteristics of participants
| Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.
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Curative
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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Breast Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer
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| Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis
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NI
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| Specifications on cancer stages
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NI
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| Comorbidities
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NI
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| Current cancer therapies
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NI
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| Specifications on cancer therapies
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NI
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| Previous cancer therapies
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NI
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| Gender
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Mixed
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| Gender specifications
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66 % female
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| Age groups
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Adults (18+)
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| Age groups specification
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Mean (Range): 90 years (85-98)
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention, Placebo
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| Number of participants (arm) N randomized
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-999
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N=0
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| Drop-out reasons
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NA
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| Intervention
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First arm:
One week of friendly visits (for baseline assessment) followed by four weekly sessions of Swedish Massage, a one-week washout period, then 4 weekly sessions of Reflexology.
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| Dosage and regime
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Swedish Massage protocol was prespecified and involved a combination of 10 minutes of light stroking and light pressure using the whole hand toplantar and dorsal surfaces and all tissue from the toes to the knee of each leg (20 minutes total). The Reflexology Intervention was based on the original Ingram method and useda combination of finger pivot and thumb walking techniquesto the base of the foot and the toes that correspond withreflex points. The sole, instep, and lateral aspects of the footwere stimulated 5 times, each foot for a total of 10 minutesper foot (20 minutes total).
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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56
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| Side effects / Interactions
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No adverse events were observed.
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention, Placebo
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| Number of participants (arm) N randomized
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-999
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N=0
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| Drop-out reasons
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NA
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| Intervention
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Second arm:
One week of friendly visits fol-lowed by four weekly sessions of Reflexology, a one-weekwashout, then 4 weekly sessions of Swedish Massage
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| Dosage and regime
|
Swedish Massage protocol was prespecified and involved a combination of 10 minutes of light stroking and light pressure using the whole hand toplantar and dorsal surfaces and all tissue from the toes to the knee of each leg (20 minutes total). The Reflexology Intervention was based on the original Ingram method and useda combination of finger pivot and thumb walking techniquesto the base of the foot and the toes that correspond withreflex points. The sole, instep, and lateral aspects of the footwere stimulated 5 times, each foot for a total of 10 minutesper foot (20 minutes total).
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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56
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| Side effects / Interactions
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No adverse events were observed.
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Outcomes
"CNPI (Behavioral observation scale for non-verbal older adults with cognitive impairment)" is not in the list (AQoL-8D (Assessment of Quality of Life), ASAT (Auditory Sustained Attention Test), BIA (Bioelectrical impedance analysis), BPI-SF (Brief Pain Inventory - Short Form), CTCAE (Common Terminology Criteria of Adverse Events), ESAS (Edmonton Symptom Assessment Scale), FAACT (Functional Assessment of Anorexia-Cachexia Therapy), FACIT (Functional Assessment of Chronic Illness Therapy), FLIE (Functional Living Index for Emesis), Genitourinary atrophy self-assessment tool, ...) of allowed values for the "Type of measurement" property.
Well-being
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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All endpoints are mean values formed from four surveys that took place over each intervention day
Observation of state of mind AARS: Positive affect
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| Type of measurement
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Observation
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Reflextherapy: The values after treatment are significantly higher than before treatment: mean diff.= 0.67; p<0.05; effect size = 0.73.
Massage: The values after the treatment are significantly higher than before the treatment: mean diff.= 0.36; p<0.05; effect size = 0.30;
The difference between the groups is not significant
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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?
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
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?
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| Overall RoB judgment
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?
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Well-being
| Outcome type As specificed by the authors
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Secondary
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| Outcome specification
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Observation of state of mind AARS: Negative affect
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| Type of measurement
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Observation
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Reflextherapy: The values after the treatment are significantly lower than before the treatment: mean diff.= -0.35; p<0.05; effect size = -0.42.
Massage: The values after the treatment are significantly lower than before the treatment: mean diff.= -0.23; p<0.05; effect size ES= -0.30;
The difference between the arms is not significant: p=0.16.
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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?
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
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?
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| Overall RoB judgment
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?
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Pain
| Outcome type As specificed by the authors
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Secondary
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| Outcome specification
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NA
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| Type of measurement
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CNPI (Checklist of Non-Verbal Pain Indicators)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
Reflextherapy: The values after the treatment are significantly lower than before the treatment Mean diff.= -0.29; p<0.05; effect size = -0.35.
Massage: The values after the treatment are significantly lower than before the treatment Mean diff.= -0.71; p<0.05; effect size ES= -0.77;
The difference between the arms is not significant: p=0.22.
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
|
?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
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| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
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Funding and Conflicts of Interest
| Funding
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This study was funded by an institutional Grant from theAmerican Cancer Society (120003 08-060-01-IRG at ThomasJefferson University).
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| Conflicts of Interest
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No conflicts of interests have been declared by the authors.
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Further points for assessing the study
Sample
| Power analysis performed
|
?
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| - Sample size corresponds to power analysis
|
?
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| - Reasons for insufficient sample size based on power analysis
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?
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| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
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?
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| Ethnicity mentioned
|
?
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Alternative Explanation
| Other explanations for an effect besides the investigated intervention
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?
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| - Possibility of attention effects
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?
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| - Possibility of placebo effects
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?
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| - Other reasons
|
?
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Statistics
| Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing
|
?
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| Correction for multiple testing
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?
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| Measurement of compliance
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?
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| Consistent reporting in numbers (figures, flowchart, abstract, results)
|
?
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| Comprehensive and coherent reporting
|
?
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| Cross-over
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?
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| - Sufficient washout period
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?
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| - Tested for carry-over effects
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?
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| - Tested for sequence effects
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?
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Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
|
?
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| Side effects systematically recorded
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?
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| Side effects considered in result interpretation
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?
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| Ethics votum
|
?
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Additional Notes
