Table 4. Characteristics of included trials (n=13).
|
Outcomea |
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|---|---|---|---|---|---|
| Measures (instruments)b |
Statistically significant |
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| Study | Participants | Interventions I=intervention and C= control | P<0.05 | Change scorec | |
| Connor (1992) California, USAStudy quality:Concealed treatment allocation: unclear Cointerventions: unclear Compliance: unclear Dropouts: 57%, n and reasons overall described, unclear if comparable between groups Intention to treat: no, patients lost clearly not in analysis | Terminally ambulatory ill cancer patientsExcluded if: Karnofsky <50 or cognitively impairedDisease stage: stage IV 100%Gender: 79% femaleMean age (range): 61 year (35–80 year) | I-group: counselling (n=13)Content: interview with patient, including questions about, for example, the most difficult aspects of having cancer? patients' believes about recovering from this illness and death?Duration: onceSetting: inpatientFormat: individual, structured, therapist-delivered,d tailor-madeC-group: usual care (no intervention) (n=11) | Emotional functioning:Death anxiety (DAS)Denial (DMI) | NS+ | —Small |
| Arathuzik (1994) Massachusetts, USAStudy quality:Concealed treatment allocation: unclear Cointerventions: unclear Compliance: strict written protocol was followed to administer the intervention Compliance monitored: unclear Dropouts: unclear Intention to treat: unclear | Patients with confirmed metastatic breast cancer and experiencing physical painExcluded if: brain metastasis or terminal stageDisease stage: stage IV 100%Gender: 100% femaleAge range: 31–80 years (46%>60 years) | I-group 1: behaviour therapy – relaxation and visualisation (n=8)Content: discussion of a detailed description of; effects of relaxation on body and visualisation or mental images on the mind; specific breathing exercise, progressive muscle relaxation exercise and visualisation that would be practiced; conditions required to practise these exercises.Deep breathing exercise, relaxing muscle groups and visualisation exercises.Duration: once 75 minSetting: in-/outpatientFormat: individual, structured, nurse-delivered, standardisedI-group 2: behaviour therapy - relaxation, visualisation and cognitive coping skills training (n=8); setting and format idem as I-group 1 Content: as I-group 1 adding to the discussion: a detailed description of the effects of distraction on pain and a review of written handouts on 23 methods of distraction.Instruction in specific positive affirmation such as ‘I can manage my pain..’Directed in practicing these affirmations and refocusing negative thoughts and feelings.Duration: once 120 minC-group: usual care (routine care and pain medication on an as needed basis) (n=8) | Emotional functioning:I-group 1: POMS subscalesI-group 1: ability to decrease pain (Rosenstiel)I-group 2: POMS subscalesI-group 2: ability to decrease pain (Rosenstiel)Physical functioning:I-group 1 and I-group 2: pain distress (Johnson Pain Distress scale) | NS+ NS+ NS | —Large — Moderate — |
| Corner et al (1996) London, UKStudy quality:Concealed treatment allocation: unclear Cointerventions: unclear Compliance: unclear Dropouts: 41%, n and reasons described by group, comparable between groups Intention to treat: no, patients lost clearly not in analysis | Patients with non-small cell lung cancer who completed chemotherapy or radiotherapy suffering breathlessnessExcluded if: not mentionedDisease stage: stage IV 100%Gender: 40% femaleMedian age: Intervention group=55 yearsControl group=69 years | I-group: counselling and behaviour therapy (n=19)Content:Detailed assessment of patient's breathlessness, their disease and feelings about the future.Advice and support were given on methods of managing breathlessness and involving family members.Breathing retraining exercises.Goal setting to assist patient to learn breathing and relaxation techniques.Duration: weekly 1 h, 3–6 weeksSetting: outpatientFormat: individual, structured, nurse-delivered, tailor-madeC-group: usual care (detailed assessment of breathlessness - no training or counselling) (n=15) | Emotional functioning:Anxiety (HADS)Depression (HADS)Physical functioning:Distress due to breathlessness (VAS)Ability to walk distances/climb stairs (Functional Capacity Scale)Difficulties performing ADL (checklist) | NS NS + + + | — — Large Small Small |
| Bredin et al (1999) London, UKStudy quality:Concealed treatment allocation: yes Cointerventions: pharmacological interventions monitored and checked for balance Compliance: supervision, audits, using practice guideline to deliver the intervention Compliance monitored: yes, by completing checklist Dropouts: 41%, n and reasons described by group, not comparable between groups Intention to treat: yes | Patients with (non-) small cell lung cancer/mesothelioma who completed treatment and reporting breathlessnessExcluded if: not mentionedDisease stage: stage IV 100%Gender:Intervention group=female 20%Control group=female 33%Mean age (range):Intervention group=68 years (41–82 years)Control group=67 years (41–83 years) | I-group: counselling and behaviour therapy (n=52)Content: Detailed assessment of breathlessness and factors that ameliorate or exacerbate it.Advice and support for patients and their families on ways of managing breathlessness.Exploration of the meaning of breathlessness, their disease, and feelings about the future.Training in breathing control techniques, progressive muscle relaxation, and distraction exercises.Goal setting to complement breathing and relaxation techniques, to help in the management of functional and social activities and to support the development and adoption of coping strategies.Early recognition of problems warranting pharmacological or medical intervention.Duration: weekly, 3–8 weeksSetting: outpatient, nursing clinicFormat: individual, structured, nurse-delivered and tailor-madeC-group: usual care (standard care, all patients had access to routinely available supportive care, that is, pharmacological, palliative treatments and treatment of associated problems such as anxiety or depression) (n=51) | Emotional functioning:Anxiety (HADS)Depression (HADS)Psychological symptom distress (RSCL)Physical functioning:Physical symptom distress (RSCL)Activity level (RSCL)Distress due to breathlessness (VAS)Global measure of QoL:QoL (RSCL) | NS + NS + + + NS | — Moderate — Large Moderate Large — |
| Edelman et al (1999) Sydney, AustraliaStudy quality:Concealed treatment allocation: yes Cointerventions: participation in outside groups monitored and tested Compliance: unclear Dropouts: 25%, n and reasons described overall, comparable between groups Intention to treat: no, patients lost clearly not in analyses | Patients with metastatic breast cancerExcluded if: psychiatric or brain disorder; drug/alcohol dependencyDisease stage: stage IV 100%Gender: 100% femaleMean age (range): 50 years (29–65 years) | I-group: behaviour therapy (cognitive–behavioural therapy techniques) and social support (n=62)Content:At the start of the programme a manual was given.Handouts and homework exercises were given at every session. Basic cognitive skills were taught, including how to identify and challenge maladaptive thoughts and beliefs. Behavioural techniques were taught, for example, deep relaxation/meditation as a tool for managing anxiety. A relaxation tape was given to practise on a regular basis. Goal setting and problem solving to gain a greater sense of control.The first hour of each session was spent on discussing homework exercises, involving, for example, the recording of potentially stressful situations that arose during the week, identifying and disputing maladaptive thoughts and underlying beliefs. Participants were also asked to suggest ‘positive actions’ that they could take in order to resolve potentially problematic situations. In the second half of each session a particular theme was discussed. This was followed by discussion with participants reflecting on ways in which they could apply the discussed strategies to their own particular circumstances and experiences.Duration: weekly, 8 weeksSetting: outpatientFormat: group, structured, therapist-delivered and tailor-madeC-group: usual care (standard oncological care) (n=62) | Emotional functioning:Anxiety (POMS)Depression (POMS) Anger (POMS) Fatigue (POMS) Confusion (POMS) Vigour (POMS) Total Mood Diaturbance (POMS)Self-esteem (Coopersmith Self Esteem Inventory) | NS + NS NS NS NS + + | — Small — — — — Small Small |
| Scholten et al (2001) AustriaStudy quality:Concealed treatment allocation: unclear Cointerventions: unclear Compliance: unclear Dropouts: unclear Intention to treat: unclear | Patients with metastatic breast cancerExcluded if: central nervous system metastasisDisease stage: stage IV 100%Gender: 100% femaleMean age (s.d.):Intervention group=61.6 years (8.7 years)Control group=62.2 years (8.1 years) | I-group: behaviour therapy – cognitive and behavioural approaches (n=20)Content:Strategies as problem solving, regaining control, setting new goals for the future.Therapy focused on patients' coping strategies, self-esteem and femininity, overcoming feeling helpless, negative thoughts and depression, and promotion of a fighting spirit.For symptom control, behavioural techniques (exercises in self-hypnosis and progressive muscle relaxation) were employed.Duration: 6 monthsSetting: outpatientFormat: individual, structured, therapist-delivered and tailor-madeC-group: usual care (patients received no psychosocial support during observation period) (n=23) | Emotional functioning: Cognitive, emotional and behavioural coping skills (semi-structured interviews) Global measures of QoL: (Non-) health related quality of life (VAS) | NS NS | — — |
| Classen et al (2001) California, USAStudy quality:Concealed treatment allocation: yes Cointerventions: all patients were offered self-directed education intervention, use was monitored and checked for balance. Compliance: supervision, use of protocol to deliver intervention Compliance monitored: unclear Dropouts: 18%, n and reasons described by group, acceptable Intention to treat: yes (for patients with at least one follow-up measurement) | Patients with confirmed metastatic or recurrent breast cancerExcluded if: Karnofsky score <70 or no metastasis beyond supraclavicular nodesDisease stage: stage IV 100%Gender: 100% femaleMean age (s.d.): Intervention group=54.0 years (10.7 years)Control group=52.9 years (10.7 years) | I-group: behaviour therapy (cognitive–behavioural approaches) and social support (n=58)Content: Supportive Expressive Therapy (SET). Therapists were trained to facilitate discussion in an emotionally expressive rather than a didactic format of the following themes:Fears of dying and death including dealing with death of group members.Reordering life priorities.Improving support from and communication with family and friends.Integrating a changed self- and body image.Improving communication with physicians.Learning self-hypnosis for pain an anxiety control.Through sharing of their experiences, group members became role models for one another. Leaders kept members focused on issues central to their diagnoses of metastatic breast cancer and on facing and grieving for their lossesDuration: weekly 1.5 h for 1 yearSetting: outpatientFormat: group, unstructured, therapist-delivered, tailor-madeC-group: usual care (no specific description) (n=44) | Emotional functioning:Total Mood Disturbance (POMS)Intrusion and avoidance – total score (IES) | + + | Small Small |
| Goodwin et al (2001) CanadaStudy quality: Concealed treatment allocation: yes Cointerventions: all patients received educational materials every 4–6 months. Unclear if use was monitored. Participation in support groups was monitored and proved comparable between groups. Compliance: use of protocol, every 9–12 months workshops, review of randomly selected videotaped sessions. Compliance monitored: unclear Dropouts: 34%, n and reasons described overall, comparable between groups Intention to treat: yes | Patients with confirmed metastatic breast cancerExcluded if: life expectancy <3 months; no metastasis beyond ipsilateral axilla; central nervous system metastasis; untreated major depression; planned participation in therapist-led support group for patients with metastatic breast cancer outside the study centerDisease stage: stage IV 100%Gender: 100% femaleMean age (s.d.): Intervention group=49.5 years (8.4 years)Control group=51.5 years (10.3 years) | I-group: behaviour therapy (cognitive–behavioural approaches) and social support (n=158)Content: SET – see Classen (2001)Duration: 90 min weekly, 1 yearSetting: outpatientFormat: group, unstructured, nurse- and therapist-delivered, tailor-madeC-group: usual care (patients did not receive any psychological therapy as part of the study but could however participate in peer support groups or therapist led support groups that did not involve SET) (n=77) | Emotional functioning:Anxiety (POMS)Depression (POMS)Anger (POMS)Fatigue (POMS)Confusion (POMS)Vigour (POMS)Total Mood Disturbance (POMS)Physical functioning:Experience of suffering | + + + NS + NS + NS | Small Small Small — Small — Small — |
| Giese-Davis et al (2002) California, USAStudy quality: Concealed treatment allocation: yes Cointerventions: all patients were offered educational materials and 1-year membership of a health library. Unclear if use was monitored. Compliance: ongoing supervision, use of protocol Compliance monitored: unclear Dropouts: 42%, n and reasons described overall, not comparable between groups Intention to treat: yes, for patients with at least one follow-up measurement | Patients with documented metastatic or recurrent breast cancerExcluded if: Karnofsky score <70 or no metastasis beyond supraclavicular nodes Disease stage: stage IV 100%Gender: 100% femaleMean age (s.d.): Intervention group=52.7 years (10.5 years)Control group=53.8 years (10.5 years) | I-group: behaviour therapy (cognitive–behavioural approaches) and social support (n=64)Content: SET – see Classen (2001)Duration: weekly 1.5 h for 1 yearSetting: outpatientFormat: group, unstructured, therapist delivered, tailor-madeC-group: usual care (no specific description) (n=61) | Emotional functioning:Anger control (CECS)Depression control (CECS)Anxiety control (CECS)Total score (CECS)Restraint (WAI)Defensiveness (WAI)Confidence communicating emotions (SESES-C)Confidence confronting death (SESES-C)Confidence focusing on present moment (SESES-C)Emotional self-efficacy total score (SESES-C) | + + NS + + NS NS NS + NS | NEe NEe NEe Small Small — — — NEe — |
| Sloman (2002) IsraelStudy quality:Concealed treatment allocation: unclearCointerventions: unclear Compliance: unclear Dropouts: unclear Intention to treat: unclear | Ambulatory patients with advanced cancer experiencing anxiety and depression without ever been trained in progressive muscle relaxation (PMR) or guided imagery (GI) Excluded if: not mentionedDisease stage: stage IV 63%Gender: 46% femaleMean age: 54.4 years (range 27–79 years) | I-group 1: behaviour therapy - progressive muscle relaxation training (n=14)Content: Nurse explained the nature of the session and turned on the taped instructions. At the end the nurse had a brief discussion concerning any problems that patients may have experienced in following the instructions.The tape recorder was left to practice PMR technique twice daily. Making of follow-up appointments for the nurse to visit subjects twice weekly to repeat the sessions and deal with any related problems.Cassette tapes contained clear instructions by a clinical psychologist that guided the subjects in the use of the techniques.Duration: 30 min, twice weekly, 3 weeks | Emotional functioning:I-group 1: Anxiety (HADS)Depression (HADS)I-group 2: Anxiety (HADS)Depression (HADS)I-group 3: Anxiety (HADS)Depression (HADS)Global measures of QoL:I-group 1: Functional Living Index Cancer Scale (FLIC)I-group 2: Functional Living Index Cancer Scale (FLIC)I-group 3: Functional Living Index Cancer Scale (FLIC) | NS + NS + NS + + + + | — Small — Small — SmallSmall Small Small |
| Setting: home careFormat: individual, structured, nurse delivered, standardizedI-group 2: behaviour therapy-guided imagery; content, duration, setting and format idem as I-group 1 but focus on GI (n=14)I-group 3: behaviour therapy−PMR+GI; content, duration, setting and format idem as I-group 1, but focus on PMR training+GI (n=14)C-group: usual care (no relaxation or imagery training; to control for placebo effect a nurse spent an equal amount of contact time with control subjects and had a general discussion about their concerns relating to their health, nursing care, and medical treatments) (n=14) | |||||
QoL=quality of life; s.d.=standard deviation; NS=nonsignificant.
a
Outcomes outside the scope of this review are not presented.
b
POMS=Profile of Moods Scale; HADS=Hospital Anxiety and Depression Scale; RSCL=Rotterdam Symptom Checklist; IES=Impact of Event Scale; DAS=Death Anxiety Scale; DMI= Defense Mechanisms Inventory; CECS=Courtauld Emotional Control Scale; WAI=Weinburger Adjustment Inventory; SESES-C= Stanford Emotional Self-Efficacy Scale - Cancer; FLIC= Functional Living Index-Cancer Scale.
c
Magnitude of the difference in change scores between groups relative to the scale used – small=change score <25%; moderate=change score between 25 and 50%; large=change score >50%.
d
When therapist is written psychotherapist and psychologist are meant.
e
NE=not evaluable, in this trial slopes analysis was used to measure change over time and only mean change of slope was given for this measure.