Barsevick 2004.
| Study characteristics | ||
| Methods |
Setting: a university health science centre in Utah and a comprehensive cancer centre in Philadelphia, USA Recruitment: eligible participants spoke English; were beginning curative or local control treatment for breast, lung, colorectal, advanced prostate, gynaecological, or testicular cancer; and planned to receive at least 3 cycles of chemotherapy, 6 weeks of radiotherapy, or concurrent chemotherapy and radiotherapy. Prior treatment other than surgery had to be completed at least 1 month previously. Participants were excluded if they were having stem cell transplantation, interleukins, interferons, or tumour necrosis factor; had chronic fatigue syndrome; were enrolled in another study involving a psycho‐educational intervention; had overt evidence of psychiatric disorder; or had initiated treatment for anaemia or depression in the past 3 weeks Randomisation: RCT |
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| Participants | 396 men and women with various cancer diagnoses | |
| Interventions |
Intervention: the Telephone Energy Conservation and Activity Management (ECAM) intervention was based on the Common Sense Model, which guided participants through 3 stages of information‐processing to help them manage cancer‐related fatigue. The intervention consisted of 3 weekly telephone sessions commencing at the beginning of chemotherapy treatment or at week 3 to 5 during radiation therapy. Session 1 consisted of coping skills training. Participants kept a journal and prioritised their usual activities. During session 2, participants were assisted to develop a care plan to minimise the interference of fatigue. In session 3, participants appraised and revised the plan. Sessions 1 and 2 each lasted 30 minutes, and session 3 lasted 15 minutes Control group: attention control consisting of information about nutrition and a healthy diet. Participants kept a dietary record for 24 hours Interventionist: research nurse |
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| Outcomes |
Methods for assessing outcomes:
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The generation of random sequence is not described |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | It is unclear whether participants were blinded to group. Interveners were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up and between‐group differences regarding reasons for it are unclear |
| Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
| Other bias | Low risk | The trial appears to be free of other problems that could put it at high risk of bias |