Study Note
Brief summary
Nearly 300 patients with advanced breast cancer were randomly assigned to one of three arms. The first arm received several sessions of reflexology, the second arm received the same number of regular foot massages, and the third arm received nothing in addition to conventional cancer treatment. All participants were surveyed at three points in time regarding various aspects of their psychological and physical quality of life: at the start of the study, one week after the last intervention, and six weeks after the last intervention. Statistical analyses were carried out rigorously. Initial differences between the arms were taken into account in the statistical analyses. When comparing the arm of patients who had received reflexology with the arm that had received regular foot massages, the first arm only performed better in one aspect: the patients reported less shortness of breath on one particular question. Compared to the arm that had not received any additional treatment, they performed better in two out of nine aspects: shortness of breath and overall psychological functioning, the latter resulting from the improvement in shortness of breath. In all other aspects, no differences were observed between the reflexology arm and the other two arms. It should be noted that shortness of breath was assessed with just one question. Additionally, the patients knew whether they were receiving a special treatment or not (no blinding), which means that the patients' positive or negative expectations may have influenced their well-being or perception. Furthermore, it should be noted that the arm difference presented was calculated from the average of all arm differences at the various points in time. So-called interaction effects were not presented. This means it cannot be determined whether the groups differed at specific times, i.e., whether there were short-term or very late effects. Side effects were systematically recorded. No side effects or interactions with the conventional cancer treatment were found.
Es wurden knapp 300 Patientinnen mit fortgeschrittenem Brustkrebs zufällig in eine von drei Gruppen eingeteilt. Die erste Gruppe hat mehrere Sitzungen Reflextherapie erhalten, die zweite Gruppe die gleiche Anzahl gewöhnlicher Fußmassagen und die dritte Gruppe hat nichts zusätzlich zur konventionellen Krebsbehandlung bekommen. Alle Teilnehmer wurden an drei Zeitpunkten zu verschiedenen Belangen der psychischen und physischen Lebensqualität befragt: zu Beginn der Studie, eine Woche nach der letzten Intervention und sechs Wochen nach der letzten Intervention. Die statistischen Analysen wurden nach allen Regeln der Kunst durchgeführt. Anfängliche Unterschiede zwischen den Gruppen wurden in den statistischen Analysen berücksichtigt. Im Vergleich der Gruppe der Patientinnen, die eine Reflextherapie bekommen hatte, mit der Gruppe, die gewöhnliche Fußmassagen erhalten hatte, schnitt die erste Gruppe nur hinsichtlich eines Belangs besser ab: die Patientinnen gaben in einer Frage an, weniger unter Atemnot zu leiden. Im Vergleich zur Gruppe, die keine zusätzliche Behandlung bekommen hatte, hatten sie in zwei von neun Belangen bessere Werte: ebenso Atemnot und grundsätzliches psychisches Funktionieren, wobei Letzteres durch die Verbesserung der Atemnot zustande kam. In allen weiteren Belangen zeigten sich keine Unterschiede zwischen der Reflextherapie-Gruppe und den anderen zwei Gruppen. Es ist anzumerken, dass Atemnot nur mit einer einzigen Frage erfasst wurde. Zudem wussten die Patientinnen, ob sie eine besondere Behandlung bekommen oder nicht (keine Verblindung), so dass auch die positive/negative Erwartung der Patientinnen ihr Befinden oder ihre Wahrnehmung verändert haben könnte. Weiterhin ist anzumerken, dass der dargestellte Gruppenunterschied aus dem Durchschnitt aller Gruppenunterschiede zu den verschiedenen Zeitpunkten berechnet wird. Sogenannte Interaktionseffekte wurden nicht dargestellt. D.h. es kann nicht erkannt werden, ob sich die Gruppen zeitweise unterschieden haben, also ob es kurzfristige oder sehr späte Effekte gab. Nebenwirkungen wurden systematisch erhoben. Es wurden keine Nebenwirkungen oder Wechselwirkungen mit der konventionellen Krebsbehandlung gefunden.
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
|
Prospective
|
| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
|
Multicentric
|
| 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
|
No
|
| Is randomized
|
Yes
|
| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
|
No
|
| Number of arms
|
3
|
Study characteristics
| Inclusion criteria
|
21 years or older; having a diagnosis of stage III or IV breast cancer, metastasis, or recurrence; being able to perform basic activities of daily living; being cognitively intact and without a documented diagnosis of mental illness; being able to speak and understand English; having access to a telephone; being able to hear normal conversation; receiving chemotherapy at intake into the study; and having a score of 11 or lower on the Palliative Prognostic Score (Pirovano et al., 1999), which indicates a 30% probability of having a life expectancy of at least three months
|
| Exclusion criteria
|
Receiving hospice care at intake, residing in a nursing home or similar care facility, being bedridden, regularly using CAM similar to those used in the protocol (e.g., reflexology, foot massage, pedicure with massage), and participating in an experimental chemotherapy protocol.
|
| N randomized
|
286
|
| 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.
|
ITT Analysis
|
| Specifications on analyses
|
Chi-square test
|
| Countries of data collection
|
United States
|
| LoE Level of evidence
|
1b Oxford 2009
|
| Outcome timeline Data collection times
|
Before randomization:
T1: 1 week after the last intervention;
T2: 6 weeks after the last intervention
|
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.
|
Palliative
|
| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
|
Breast Cancer
|
| 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
|
Advanced Stage, ?
|
| Specifications on cancer stages
|
Andvanced stage (III-IV, metastatic or recurrent)
|
| Comorbidities
|
NI
|
| Current cancer therapies
|
Chemotherapy, Hormone therapy
|
| Specifications on cancer therapies
|
NI
|
| Previous cancer therapies
|
Diverse
|
| Gender
|
Female
|
| Gender specifications
|
100 % female
|
| Age groups
|
Adults (18+)
|
| Age groups specification
|
Mean = 56 years
|
Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
|
Intervention
|
| Number of participants (arm) N randomized
|
95
|
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
|
N=0
|
| Drop-out reasons
|
NA
|
| Intervention
|
Reflexology
|
| Dosage and regime
|
30min., 1x week, 4 weeks in total
|
| One-time application
|
No
|
| 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.
|
4
|
| Side effects / Interactions
|
NI
|
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
|
Intervention
|
| Number of participants (arm) N randomized
|
95
|
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
|
N=0
|
| Drop-out reasons
|
NA
|
| Intervention
|
Foot massage (LFM)
|
| Dosage and regime
|
30min., 1x week, 4 weeks in total
|
| One-time application
|
No
|
| 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.
|
4
|
| Side effects / Interactions
|
NI
|
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
|
Placebo
|
| Number of participants (arm) N randomized
|
96
|
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
|
N=0
|
| Drop-out reasons
|
NA
|
| Intervention
|
Conventional therapy, control arm
|
| Dosage and regime
|
30min., 1x week, 4 weeks in total
|
| One-time application
|
No
|
| 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.
|
4
|
| Side effects / Interactions
|
NI
|
Outcomes
Quality of life
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Breast cancer-specific QOL with FACT-B: physical, emotional, social, functional, breast cancer-specific concerns subscales and total scale
|
| Type of measurement
|
FACT (Functional Assessment of Cancer Therapy)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: 0.387 [2.194]; p= 0.86, reflexology arm/control arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Unspecified effects
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Dyspnea with a single item from the FACT-B other concerns subscale
|
| Type of measurement
|
FACT (Functional Assessment of Cancer Therapy)
|
| 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".
|
NA
|
| 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".
|
Sig. better values in reflexology arm than control arm (β= 0.39 [0.13]; p<0.01, reflexology arm: Mean-T1=3.33, Mean-T2=3.36, control arm: Mean-T1 (1 week after last intervention)=3.1 M-T2 (6 weeks after last intervention)=2.9, effect T1 (1 week after last intervention)= 0.36, effect T2 (6 weeks after last intervention)= 0.51).
Sig. better values in reflexology arm than in foot massage arm (β=NI; p=0.02, foot massage arm: Mean-T1 (1 week after last intervention)=3.1, Mean-T2 (6 weeks after last intervention) =3.03, effect T1 (1 week after last intervention) =NI, effect T2 (6 weeks after last intervention=NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Nausea
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Nausea with single item from the FACT-B physical subscale
|
| Type of measurement
|
FACT (Functional Assessment of Cancer Therapy)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: β=0.212[0.124], p=0.089, reflexology arm/foot massage arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Physical functioning
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Physical function level with SF-36: physical function subscale
|
| Type of measurement
|
SF-36 (Short Form-36 Health Survey)
|
| 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".
|
NA
|
| 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".
|
Sig. higher (better) values for reflexology arm than control arm (ß= 5.527 [2.728]; p=0.04, reflexology arm: Mean-T1 (1 week after last intervention)= 58.6, Mean-T2 (6 weeks after last intervention) =59.2, control arm: Mean-T1 (1 week after last intervention)= 54.9 Mean-T2 (6 weeks after last intervention)= 51.6, effect T1 (1 week after last intervention=0.21, effect T2 (6 weeks after last intervention) = 0.44).
No sig. difference between reflexology arm and control arm (NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Fatigue
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Fatigue severity with single item from the BFI
|
| Type of measurement
|
BFI (Brief Fatigue Inventory)
|
| 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".
|
NA
|
| 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".
|
No sig. difference between the arms (reflexology arm/control arm: ß= -0.335 [3.81]; p=0.38, reflexology arm/foot massage: NI).
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Fatigue
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Disruption of daily activities due to fatigue with single item from the BFI
|
| Type of measurement
|
BFI (Brief Fatigue Inventory)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: ß= -2.87 [0.389]; p=0.46; reflexology arm/foot massage arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Pain
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Pain intensity with a single item from the Brief Pain Inventory-Short Form
|
| Type of measurement
|
BPI-SF (Brief Pain Inventory - Short Form)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: ß= -2.87 [0.389]; p=0.46; reflexology arm/foot massage arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Depression
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
NA
|
| Type of measurement
|
CES-D (Center for Epidemiologic Studies - Depression Scale)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: ß= -0.487 [1.21]; p=0.69; reflexology arm/foot massage arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Anxiety
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
NA
|
| Type of measurement
|
STAI (State-Trait-Anxiety-Inventory)
|
| 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".
|
NA
|
| 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".
|
No sig. differences between the arms (reflexology arm/control arm: ß= -0.886 [1.259]; p=0.48; reflexology arm/foot massage arm: NI)
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Funding and Conflicts of Interest
| Funding
|
This work was supported by a grant (#R01 CA104883) from the National Institutes of Health (NIH), National Cancer Institute. The Branch Reflexology Institute and Biostatistics, Epidemiology, and Research Design (BERD) Core of the Center for Clinical and Translational Sciences (CCTS) is primarily funded by an NIH Clinical and Translational Science Award grant (UL1 RR024148), awarded to the University of Texas Health Science Center at Houston in 2006. Wyatt can be reached at gwyatt@msu.edu, with copy to editor at ONFEditor@ons.org
|
| Conflicts of Interest
|
NI
|
Further points for assessing the study
Sample
| Power analysis performed
|
?
|
| - Sample size corresponds to power analysis
|
?
|
| - Reasons for insufficient sample size based on power analysis
|
?
|
| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
|
?
|
| Ethnicity mentioned
|
?
|
Alternative Explanation
| Other explanations for an effect besides the investigated intervention
|
?
|
| - Possibility of attention effects
|
?
|
| - Possibility of placebo effects
|
?
|
| - Other reasons
|
?
|
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
|
?
|
| Correction for multiple testing
|
?
|
| Measurement of compliance
|
?
|
| Consistent reporting in numbers (figures, flowchart, abstract, results)
|
?
|
| Comprehensive and coherent reporting
|
?
|
| Cross-over
|
?
|
| - Sufficient washout period
|
?
|
| - Tested for carry-over effects
|
?
|
| - Tested for sequence effects
|
?
|
Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
|
?
|
| Side effects systematically recorded
|
?
|
| Side effects considered in result interpretation
|
?
|
| Ethics votum
|
?
|
Additional Notes
PRO:
Large, multicenter sample;
Statistical model with repeated measures (no multiple testing), intention-to-treat analysis and covariates (group differences from baseline in depression and anxiety were controlled);
Survey of NW not with CTCAE, but systematically with own criteria
CONTRA:
No blinding when conducting the study, although this would have been possible (subjective outcomes)
Dyspnoea, which is also the mediator for the effects of physical function (outcome 4), was itself only measured with a single item (internal validity).
No indication of the specific results of the group comparisons between arm A and arm B (i.e. the comparisons with the active control group), except for the one significant effect on dyspnoea (reduced reporting)
