Smith et al. (2004)

Smith et al. (2004)
Design: Randomised crossover trial evidence level: 1
Country: UK
Inclusion criteria:
Age < 80 years
Life expectancy > 6 months
Symptomatic stage II or III multiple myeloma either at plateau phase or receiving active treatment
Settled home environment
Written informed consent
Exclusion criteria:
Concomitant use of other trial drugs or bisphosphonates
Number of patients = 37, age range 36 to 80 years, mean age = 65 years
Six 4-weekly cycles of pamidronate at 90 mg infused i.v. over 90 min, given for the management and prophylaxis of multiple myeloma. Treatment was given either in the home or at hospital. Patients were randomised to receive iv treatment for 3 months in one setting before crossing over to the other arm for a similar 3 months of treatment.
Patient/carer preference for treatment (assessed on a visual analogue scale from 0 (not acceptable) to 100 (extremely acceptable)) quality of life (QOL - assessed by the EORTC QLQ- C30 tool).

EORTC QLQ-C30 measures functional scales, global health status and quality of life (where high scores are optimal) and symptoms scales (where low scores are optimal). In all cases the range of scores is 0–100 and numerical differences between arms can be analysed for statistical significance.
Follow up:
The EORTC-QLQ-C30 questionnaire was completed at baseline and at the end of each 3-month treatment period.

34/37 patients completed the hospital phase and 33/37 completed the home treatment phase.

Of the 18 patients randomised to the hospital arm, 2 patients died of progressive disease and 1 patient withdrew consent having experienced adverse events. Of the 19 patients randomised to the home treatment arm, 2 patients withdrew because of co-existing morbidity (one subsequently died of disease progression).
Patient/carer preference for treatment (scale of 0–100):
Home care treatment = 91.8
Hospital treatment = 69.7
mean difference (home care – hospital care) = 22.2 (95%CI: 11.1–33.3) (P < 0.05)

At the close of the study, when patients were asked to state a preference for treatment location 81% of patients stated that they preferred the home setting (P < 0.001)

Functional (physical, role, emotional, cognitive, social) = nsd between home and hospital treatment
Symptoms (fatigue, nausea & vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) = nsd between home and hospital treatment
Global health status/QOL = nsd between home and hospital treatment
The low patient number, even for a crossover trial, may have contributed to the lack of significance.

There were no reports of adverse events which could be considered to be due to the location of treatment administration.
General comments:
This paper presents results from the Pilot Aredia Treatment at Home (PATH) study which was a prospective, open label, randomised, crossover multicentre (n = 4) trial of treatment with intravenous pamidronate in the home or hospital setting.

Home treatment was given by an appropriately trained nurse, usually the hospital clinic nurse. In one centre the infusions were given by an outside agency but in the presence of the clinic nurse. Hospital treatments were according to standard practice, integrated into a regular day ward or clinic setting according to the individual centre.

According to the authors, there were some differences between centres in the proportions of patients with stable or progressive disease – further details were not given. Such bias may have affected the quality of life outcomes.

This is a small study which suggests, at least for this group of participants, that home treatment is the preferred option for patient satisfaction although this is not supported by the structured evaluation tool. The majority of clinical nurses, when asked, said that the home treatment had taken more time than the hospital treatment. The approximate measure of how much more time ranged between < 25 and up to 100%, a factor that could affect cost-benefit ratios.

From: Chapter 5, Community-based treatment and supportive care

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