Latest revision as of 16:00, 30 November 2024

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Title	A randomised, controlled trial of the psychological effects of reflexology in early breast cancer
Topic	Reflexology
Author	Sharp DM, Walker MB, Chaturvedi A, Upadhyay S, Hamid A, Walker AA, Bateman JS, Braid F, Ellwood K, Hebblewhite C, Hope T, Lines M, Walker LG
Year	2010
Journal	European Journal of Cancer
DOI	https://doi.org/10.1016/j.ejca.2009.10.006

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 group 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 arm 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	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	Single
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	Female; over 18 years of age; newly diagnosed histologically proven early breast cancer (T1, T2 [<3 cm], N0, N1a, M0); received breast surgery; WHO status 0 or 1; willing to give written, informed consent; and able to complete questionnaires
Exclusion criteria	History of cancer (excluding basal cell carcinoma), participating in another clinical trial and clinically significant cognitive impairment or dementia.
N randomized	183
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	ANOVA and chi-square test
Countries of data collection	United Kingdom - Great Britain
LoE Level of evidence	1b Oxford 2009
Outcome timeline Data collection times	T0: 6 weeks post surgery; T1: 18 weeks post surgery; T2: 24 weeks post surgery

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.	Adjuvant
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	Early Stage
Specifications on cancer stages	Early breast cancer
Comorbidities	NI
Current cancer therapies	Chemotherapy, Radiation therapy
Specifications on cancer therapies	NI
Previous cancer therapies	Surgery
Gender	Female
Gender specifications	100 % female
Age groups	Adults (18+)
Age groups specification	Range 32-81 years; Mean 58.78 years (SD:10.31)

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	60
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	Intervention 1: reflexology plus self-initiated support (SIS) in the Oncology Health Centre.
Dosage and regime	8 one-hour sessions at weekly intervals for 8 weeks commencing 7 weeks after surgery. 7 weeks post surgery to 15 weeks post surgery
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.	8
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	61
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=1
Drop-out reasons	NI
Intervention	Intervention 2: scalp massage plus (SIS) (comparator intervention – identical amount of physical and social contact) 7 weeks post surgery to 15 weeks post surgery
Dosage and regime	8 one-hour sessions at weekly intervals for 8 weeks commencing 7 weeks after surgery.
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.	8
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	62
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=2
Drop-out reasons	NI
Intervention	?
Dosage and regime	Intervention 3: SIS (comparator intervention – treatment asusual). 7 weeks post surgery to 15 weeks post surgery
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.	8
Side effects / Interactions	NI

Outcomes

Quality of life

Outcome type As specificed by the authors	Primary
Outcome specification	Trial Outcome Index (TOI) from the FACT-B at Baseline end-point 1 (week 18 post surgery).
Type of measurement	EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire), 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".	Significant better values for intervention 2 than intervention 3 (intervention 2: 73.06 [70.89,75.23], intervention 3: 69.05 [66.90,71.21]; p=0.03). No significant difference between the other arms.
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".	NA

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	?

Quality of life

Outcome type As specificed by the authors	Secondary
Outcome specification	QQL and FACT-B: TOI-Scale at 18 weeks post surgery
Type of measurement	EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire), 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".	Significant better values for intervention 1 than intervention 2 (intervention 1: 74.82 [72.13,77.55], intervention 3: 69.42 [66.75,72.09]; p=0.02). No significant differences between the other arms
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".	NA

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	?

Mood/Affect

Outcome type As specificed by the authors	Secondary
Outcome specification	Relaxation Scale (Baseline, 18 weeks pot surgery; 24 weeks post surgery)
Type of measurement	MRS (Mood Rating 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".	Significant better values on the total scale and the relaxation subscale for intervention 1 and intervention 2 respectively compared to intervention 3 at T1 (18 weeks post surgery) (intervention 1: 100.94 [91.36,110-53], intervention 2: 100.23 [90.77,109.69], intervention 3: 69.05 [66.90,71.21]; p[AC]<0.0005, p[BC]<0.0005 ). Significant better scores on the relaxation subscale for intervention 1 than intervention 2 at T2 (24 weeks post surgery) (intervention 1: 107.30 [97.91,116.69], intervention 3:89.07 [79.82,98.32]; p=0.02). No significant differences between the other arms at T2 (24 weeks post surgery).
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".	NA

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	?

Mood/Affect

Outcome type As specificed by the authors	Secondary
Outcome specification	Mood with other scales (Baseline, 18 weeks post surgery; 24 weeks post surgery)
Type of measurement	SCID (Structured Clinical Interview for DSM IV), MRS (Mood Rating 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".	Significant better values on the “easy-goingness” scale for intervention 1 than intervention 2 or intervention 3 at T1 (18 weeks post surgery) (intervention 1: 98.70 [90.12,107.27], intervention 2: 113.98 [105.49,122.46], intervention 3: 89.18 [80.73,97.63], p[AB]=0.04, p[BC]<0.0005).
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".	NA

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	?

Quality of life

Outcome type As specificed by the authors	Secondary
Outcome specification	QQL with FACT-B physical, functional, emotional, social and additional worry scale (baseline, 18 weeks post surgery, 24 weeks post surgery)
Type of measurement	EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire)
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".	No significant differences between all three arms at T1 (18 weeks post surgery). Significant better values for intervention 1 than Intervention 2 in the total scale as well as in the subscale “functional well-beeing” at T2 (24 weeks post surgery) (total scale: intervention 1: 118.60 [114.93,112.26], intervention 3: 111.70 [108.10,115.30]; p=0.03, “functional wellbeing”: intervention 1: 23.17 [22.01,24.33], intervention 3: 21.04 [19.90,22.17]; p=0.03). No significant differences between the other arms.
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".	NA

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	Secondary
Outcome specification	Anxiety and Depression (Baseline, 18 weeks post surgery, 24 weeks post surgery)
Type of measurement	HADS (Hospital Anxiety and Depression Scale), SCID (Structured Clinical Interview for DSM IV)
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".	No significant differences between all three arms at T1 (18 weeks post surgery) and T2 (24 weeks post surgery)
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".	NA

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	?

Mental status/ function

Outcome type As specificed by the authors	Secondary
Outcome specification	Psychiatric morbidity rate
Type of measurement	SCID (Structured Clinical Interview for DSM IV)
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".	No significant differences between all three arms at T1 (18 weeks post surgery) and T2 (24 weeks post surgery).
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".	NA

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	None declared.
Conflicts of Interest	Research supported by UK National Health Service, National Cancer Research and Development Programme NCP2/X229.

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

Additional Complementary and Alternative Medicine therapies assessed with CMQ (Complementary Therapies Questionnaire ) with no significant differences between all three arms at T1 (18 weeks post surgery) and T2 (24 weeks post surgery)