Study Note
Brief summary
Three different arms of breast cancer patients were compared with each other after their operation: The first arm received reflex therapy, the second head massage and the third nothing beyond usual care. Three different questionnaires were used in all arms to find out how they were doing in various psychological and physical areas before and after treatment. Very similar points were asked, namely general well-being, relaxation, happiness, energy and self-confidence. The people included in the arms were comparable in all respects at the beginning of the study. The arm that received reflex therapy had demonstrably better values after the treatment than the arm that did not receive any additional treatment in a total of 6 out of 34 comparisons and better values than the group that received the head massage in 1 out of 34 comparisons. These demonstrable differences are small (e.g. 119 instead of 112 total points for general well-being). The authors of the study emphasize these differences, but do not go into why no differences were found in other similar points.
Es wurden drei verschiedene Gruppen von Brustkrebspatientinnen nach ihrer Operation miteinander verglichen: Die erste Gruppe hat Reflextherapie bekommen, die zweite Kopfmassage und die dritte nichts weiter, was über die übliche Versorgung hinausging. In allen Gruppen wurden drei verschiedene Fragebögen angewendet, um herauszufinden wie es ihnen in verschiedenen psychischen und körperlichen Belangen jeweils vor und nach der Behandlung ging. Dabei wurden sehr ähnliche Punkte abgefragt, nämlich allgemeines Wohlbefinden, Entspannung, Fröhlichkeit, Energie, Selbstbewusstsein. Die Personen, die in den Gruppen eingeschlossen wurden, waren zu Beginn der Studie in allen Belangen vergleichbar. Die Gruppe, die Reflextherapie bekommen hat, hatte nach der Behandlung in insgesamt 6 von 34 erhobenen Vergleichen nachweislich bessere Werte als die Gruppe, die nichts zusätzliches bekommen hat und in 1 von 34 Vergleichen bessere Werte als die Gruppe, welche die Kopfmassage bekommen hat. Diese nachweislichen Unterschiede sind gering (z.B. 119 statt 112 Gesamtpunkte für allgemeines Wohlbefinden). Die Autoren der Studie heben diese Unterschiede sehr hervor, gehen aber nicht darauf ein, warum in anderen ähnlichen Punkten keine Unterschiede gefunden werden konnten.
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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No
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| Number of arms
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3
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Study characteristics
| Inclusion criteria
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?
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| Exclusion criteria
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?
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| N randomized
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-999
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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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?
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| Specifications on analyses
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?
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| Countries of data collection
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?
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| LoE Level of evidence
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?
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| Outcome timeline Data collection times
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?
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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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?
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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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?
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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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?
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| Specifications on cancer stages
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?
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| Comorbidities
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?
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| Current cancer therapies
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?
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| Specifications on cancer therapies
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?
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| Previous cancer therapies
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?
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| Gender
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?
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| Gender specifications
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?
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| Age groups
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| Age groups specification
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?
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Arms
Outcomes
Funding and Conflicts of Interest
| Funding
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?
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| Conflicts of Interest
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?
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Further points for assessing the study
Sample
| Power analysis performed
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?
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| - Sample size corresponds to power analysis
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?
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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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?
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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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?
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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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?
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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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?
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| Comprehensive and coherent reporting
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?
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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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?
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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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?
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Additional Notes
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