Main reference: Borras et al. 2001,35 full published paper
Linked references: none
Design: RCT (parallel group)
Country: Spain
Recruitment period: October 1997 to October 1998
Number of recruiting centres: one
Assessment time points: ‘Treatment completion’. This was approximately 6–8 months for palliative patients and 12 months for adjuvant patients | Key characteristics of recruited population:
Inclusion criteria: adults (aged 18–75 years) with colorectal cancer were eligible
Mean age: 60 years
Gender: 45/87 male (52%)
Cancer type: colon 40/87 (46%); rectum 27/87 (31%); advanced disease 20/87 (23%)
Mean Karnofsky index score: 83
Treatment intention: curative (adjuvant) 70/87 (80%) or palliative 17/87 (20%)
Chemotherapy used: fluorouracil | Setting details: home
Delivered by a trained nurse (no further details)
Hospital (outpatient)
Standard care in outpatient clinic (no further details)
Preparation of chemotherapy: NR | Target sample size: NR
Number actually randomised: 87
Estimated monthly rate of randomisation, per centre: 6.7
Number of eligible participants who were not randomised because of setting preference: NR (only one eligible patient was not randomised)
Did it appear that all eligible patients were invited to participate? NR
Withdrawals and dropouts
31/87 (36%) patients did not complete chemotherapy
6/42 (14%) outpatients and 1/45 (2%) home patient withdrew voluntarily (no reason details provided)
13/42 (31%) outpatients and 11/45 (24%) home patients withdrew because of toxicity, disease progression or doctor advice | Primary outcome(s): not specified
Other outcomes: treatment toxicity (ECOG); withdrawals; use of health-care resources; quality of life (EORTC QOL-C30); satisfaction with health care; Karnofsky Index
Qualitative data reported? No
Economic data reported? Yes
Comments |
Main reference: Chen and Hasuimi 1999,27 conference abstract
Linked references: none
Design: randomised trial
Country: Japan
Recruitment period: NR
Number of recruiting centres: one
Assessment time points: days 1, 3 and 5 of first course of chemotherapy | Key characteristics of recruited population: the only details reported were that patients had been operated on for ovarian cancer
Treatment intention: NR
Chemotherapy used: all patients received cisplatin 15 mg per square metre (days 1–5), doxorubicin 35 mg per square metre (day 1), cyclophosphamide 350 mg per square metre (day 1) | Setting details: home; outpatient
Preparation of chemotherapy: NR | Target sample size: NR
Number actually randomised: 10
Estimated monthly rate of randomisation: cannot be calculated
Number of eligible participants who were not randomised because of setting preference: NR
Did it appear that all eligible patients were invited to participate? NR
Withdrawals and dropouts: NR | Primary outcome(s): not specified
Other outcomes: quality of life, State Trait Anxiety Inventory, mean nursing time
Qualitative data reported? No
Economic evaluation: no
Comments: the study aimed to compare the effect of setting on outcomes following the first course of chemotherapy. One group received the first course at home (followed by outpatient chemotherapy) and the other received the first course in the outpatient setting (followed by home chemotherapy) |
Main reference: Christiansen et al. 2011,28 conference abstract
Linked references: none
Design: RCT (crossover)
Country: Denmark
Recruitment period: November 2007 to November 2010
Number of recruiting centres: one
Assessment time points:
Quality of life: at baseline and before each treatment (total of eight treatments including initial outpatient clinic treatment)
Preference: at baseline, change of treatment setting, and end of treatment | Key characteristics of recruited population:
Inclusion criteria: patients with colon cancer who were eligible to receive adjuvant treatment with oxaliplatin and capecitabine
Median age: 64 years
Gender: 27/51 (53%) female
Treatment intention: curative (adjuvant)
Chemotherapy used: oxaliplatin and capecitabine every 3 weeks | Setting details: home
Hospital (outpatient): all patients received first infusion at the outpatient clinic before randomisation (for safety reasons)
No further details for either setting were reported
Preparation of chemotherapy: NR | Target sample size: NR
Number actually randomised: 51
Estimated monthly rate of randomisation, per centre: 1.4
Number of eligible participants who were not randomised because of setting preference: NR
Did it appear that all eligible patients were invited to participate? NR
Withdrawals and dropouts: 14 patients did not complete all eight treatments | Primary outcome(s): not specified
Other outcomes: quality of life (EORTC QLQ-C30); adverse effects; time spent receiving chemotherapy; patient preference; costs
Qualitative data reported? No
Economic evaluation: no
Comments |
Main reference: Corrie et al. 2013,4 full published paper
Linked references: protocol;98 conference posters;99,100 project report form (Corrie, 2013, Cambridge University Hospitals NHS Foundation Trust, unpublished document)
Design: RCT (parallel group)
Country: England
Recruitment period: January 2009 to May 2011
Number of recruiting centres: two
Assessment time points: 4, 8 and 12 weeks. Optional 24-week (or treatment cessation) assessment | Key characteristics of recruited population:
Inclusion criteria: adults with an ECOG status of 0–2, scheduled to receive at least 12 weeks of treatment, living within a 30-minute drive of the recruiting hospital, and infusion lasting no more than 4 hours
Exclusion criteria: life expectancy under 6 months, participation in a clinical trial (of unlicensed drug)
Gender: 33/97 male (34%)
Cancer type: breast 36/97 (37%); lung 27/97 (28%); pancreatic 21/97 (22%); other 13/97 (13%)
ECOG status: 0 = 65/97 (67%); 1 = 26/97 (27%); 2 = 6/97 (6%)
Prior cancer drug: no = 50/97 (52%), yes = 47/97 (48%)
Treatment intention: curative (33%), palliative (53%) or supportive care (14%)
Chemotherapy used: no details on drugs or regimes used, but delivered based on standard operating procedures | Setting details:
Home: chemotherapy delivered by a single nurse in the patient’s home
GP surgery: offered a choice of three local surgeries all with free parking and conveniently located with respect to the two recruiting hospitals
Hospital: outpatient and day unit
Preparation of chemotherapy: chemotherapy drugs prepared by oncology pharmacists in the two key hospitals, then dispensed and collected by nurse for delivery in the community | Target sample size: 390
Number actually randomised: 97
Estimated monthly rate of randomisation, per centre: 1.7
Number of eligible participants who were not randomised because of setting preference: 53. 16 patients were reluctant to receive treatment at a GP surgery, two did not want home treatment and 35 wanted to be treated in hospital
Did it appear that all eligible patients were invited to participate? The authors indicated that clinicians were somewhat reluctant to refer patients into the trial, citing concerns about patient and nurse safety and resource use. Also see ‘Comments’
Withdrawals and dropouts: data for 57 patients could be analysed at end of trial. Six patients failed to start treatment, 17 patients did not complete 12 weeks of treatment
Home: 33 allocated, 33 started, five stopped, five incomplete data sets
GP: 32 allocated, 29 started, eight stopped, four incomplete data sets
Hospital: 32 allocated, 29 started, four stopped, right incomplete data sets | Primary outcome(s): patient-reported quality of life, using the Emotional Function domain of the EORTC QLQ-30 questionnaire
Other outcomes: EORTC QLQ-C30 (self-rated health); HADS Anxiety; HADS Depression; EQ-5D; costs; satisfaction; serious adverse events
Economic evaluation? Yes
Type of economic evaluation: CUA
Currency (price year): GBP (£) NR
Study perspective: not explicitly reported, appears to be NHS perspective
Qualitative data reported? Yes
Comments: the trial stopped prematurely due to poor accrual rate, on the advice of the independent data monitoring committee
Results reported only as differences (between groups) |
Main reference: Hall and Lloyd 2008,30 full paper
Linked references: none
Design: RCT (parallel)
Country: UK (England)
Recruitment period: 6 months (no dates reported)
Number of recruiting centres: one
Assessment time points: after the 4th treatment cycle | Key characteristics of recruited population:
Inclusion criteria: breast cancer patients intending to receive a minimum of four cycles of anthracycline-based chemotherapy
Cancer type: breast cancer
No other data regarding patient characteristics were provided
Treatment intention: treatment used either to prevent recurrence or metastatic spread in early-stage disease, or for palliation of symptoms in advanced disease cases
Chemotherapy used: anthracycline-based chemotherapy | Setting details:
Home: no details reported
Hospital (outpatient): no details reported
Preparation of chemotherapy: NR | Target sample size: 20
Number actually randomised: 15
Estimated monthly rate of randomisation, per centre: 2.5
Number of eligible participants who were not randomised because of setting preference: NR
Did it appear that all eligible patients were invited to participate? Patients were identified as being suitable for the study by oncologists or breast cancer nurse specialists at their oncology appointments, and were recruited by the nurse consultant
Withdrawals and dropouts: NR | Primary outcome(s): not specified
Other outcomes: patient experience and satisfaction; costs
Qualitative data reported? Yes
Economic data reported? No
Comments: primarily a qualitative study |
Main reference: King et al. 2000,31 full published paper
Linked references: King et al. 2001,54 letters to editor; Caleo et al. 1996,101 conference abstract
Design: RCT (crossover)
Country: Australia
Recruitment period: 1993–5
Number of recruiting centres: two
Assessment time points:
Patient quality of life: recruitment to study and at each chemotherapy treatment session
Preference and satisfaction: after 2 and 4 months (end of setting periods)
Unmet needs: NR | Key characteristics of recruited population:
Inclusion criteria: patients who lived in a ≈ 20 km radius of the respective hospital and whose planned treatment consisted of one of the trial chemotherapy regimens
Mean age: NR
Gender: NR
Cancer type:
Early colon cancer: 27/74 (36%)
Early-stage breast cancer: 21/74 (28%)
Metastatic breast cancer: 25/74 (34%)
Head and neck cancer: 1/74 (1%)
Treatment intention: adjuvant (colon and early breast cancer, 65%) or palliative (metastatic breast cancer, 34%); NR for head and neck cancer
Chemotherapy used: 5-flourouracil and levamisole (colon cancer); intravenous CMF, methotrexate and 5-fluorouracil (CMF; early breast cancer); oral CMF (metastatic breast cancer); and methotrexate (head and neck cancer) | Setting details:
Home: treatment provided by existing hospital-based oncology nursing staff. Nurses travelled from the medical oncology unit closest to the patient’s home
Hospital (outpatient): no details provided
Preparation of chemotherapy: NR | Target sample size: NR
Number actually randomised: 74
Estimated monthly rate of randomisation, per centre: 1.5
Number of eligible participants who were not randomised because of setting preference: 13. Four patients felt safer in hospital; two thought that their home was unsuitable owing to social problems; one did not want to associate home with chemotherapy; and six thought that being in the study would be more inconvenient than regular hospital care
Did it appear that all eligible patients were invited to participate? Patient recruitment to the trial was dependent on the medical oncologist or oncologist nurses’ judgement of the patient’s applicability to the trial
Withdrawals and dropouts: 34 (46%) patients did not complete both home and hospital treatments. Eight patients revoked consent to home treatment after receiving hospital treatment in the run-in period. Four patients developed conditions (mostly poor venous access) which meant that chemotherapy was technically too difficult to administer at home. Two patients moved residence outside the treatment zone | Primary outcome(s): not specified
Other outcomes: patient and carer preferences and strength of preference; patient and carer satisfaction; unmet patient needs; patient quality of life (FLIC); costs
Qualitative data reported? No
Economic evaluation? Yes
Type of economic evaluation: CEA
Currency (price year): AUD ($) NR
Study perspective: health service
Comments: one ineligible patient was recruited at a time when participation rates were low |
Main reference: Pace et al. 2009,29 full published paper
Linked references: Pace et al. 2007102
Design: RCT (crossover)
Country: UK (England)
Recruitment period: August 2005 to August 2006
Number of recruiting centres: one
Assessment time points:
Based on cycles: 1, 3, 4, 5 and completion for most outcomes, toxicity measured at each cycle | Key characteristics of recruited population:
Inclusion criteria: patients ≥ 18 years without previous chemotherapy treatment, scheduled to receive standard chemotherapy for at least six cycles suitable for day-case administration, without other uncontrolled medical illness. WHO status of 0, 1, 2
Median age: 57 years (range 40–80 years)
Gender: male 7/42 (17%); female 35/42 (83%)
Disease stage: early 29/42 (69%); advanced 13/42 (31%)
Cancer type: breast 32/42 (76%); pancreas 2/42 (5%); prostate 2/42 (5%); melanoma 2/42 (5%); other 4/42 (9%)
Treatment intention: ‘standard chemotherapy’; no further details given
Chemotherapy used: anthracycline-based regimes 31/42 (74%) gemcitabine; carboplatin-based regimes; docetaxel; dacarbazine; COIN study treatment | Setting details:
Community (OUTREACH centre): four centres none previously having delivered chemotherapy. Facilities included a waiting area, emergency call facilities and resuscitation equipment. Only chemotherapy was delivered during sessions in these areas
Located 6, 13, 20 and 25 miles from the cancer centre
Hospital outpatient: dedicated chemotherapy suite within an oncology unit, including dedicated patient support and information centre. All chemotherapy was delivered by members of the hospital chemotherapy team both in the cancer centre and within the community settings
Preparation of chemotherapy: chemotherapy was made to prescription for individual patients and delivered to the oncology day unit. From there it was collected and then taken to the community hospital by a member of the team | Target sample size: 30
Number actually randomised: 42
Estimated monthly rate of randomisation, per centre: 3.2
Number of eligible participants who were not randomised because of setting preference: five, all female, reasons relating to safety concerns or convenience
Did it appear that all eligible patients were invited to participate? Participants were recruited from a consecutive series, estimated 98 were eligible, most reasons for non-entry were unknown
Withdrawals and dropouts: 38 (90.5%) completed the first two cycles of chemotherapy at the first location; 31 (73.8%) completed the first four cycles of chemotherapy and therefore crossed over from one location to the second; and 28 (66.7%) completed six cycles of chemotherapy
Reasons for withdrawal: disease progression and cessation of chemotherapy | Primary outcome(s): patient preference for location of treatment (measured via questionnaire)
Other outcomes: HADS; C-SAS (toxicity scale); CPSQ (patient satisfaction questionnaire); resource use; safety
Qualitative data reported? Yes
Economic data reported? Yes
Type of economic evaluation: CEA
Currency (price year): GBP £ NR
Economic perspective: NHS and patient (not explicitly reported)
Comments: authors comment that the preference for the outreach location was not mirrored in global CPSQ and HADS scores. They suggest that the CPSQ and HADS may be missing aspects of the chemotherapy experience that people consider important, and determine their treatment location preferences
Project was not pursued further due to lack of funding; however, a local patient-led initiative has established a charity and funds the OUTREACH project. See www.chemooutreachproject.co.uk for more details |
Main reference: Remonnay et al. 2002,34 full paper
Linked references: Remonnay et al. 2003,103 full published paper (French)
Design: RCT (crossover)
Country: France
Recruitment period: October 1995 to June 1998
Number of recruiting centres: one
Assessment time points: patients were assessed after two courses of chemotherapy, switched from home to hospital or vice versa, and then were assessed after two further courses of chemotherapy | Key characteristics of recruited population:
All patients had previously been hospitalised at the recruiting centre
Inclusion criteria: the patient must have not received chemotherapy in the previous 2 months, the patient lived in the geographical area covered by Soins et Santè, the patient lived with a family member, the patient’s personal physician consented, and the patient had permanent access to a vein or an implantable venous access system (Port-A-Cath)
Mean age: 60 years (SD 11 years)
Gender: 17% male
Type of cancer: mostly breast cancer (81%). Some patients had non-small cell lung cancer
Treatment intention: unclear
Chemotherapy used: most frequently used chemotherapy regimens were cyclophosphamide and doxorubicin, cyclophosphamide, methotrexate, and 5-fluorouracil and navelbine | Setting details:
Home: no details reported
Outpatient: no details reported
Preparation of chemotherapy: it was unclear where the chemotherapy was prepared, but costs for drugs were higher for home care due to not being provided by the hospital | Target sample size: 160
Number actually randomised: 52
Estimated monthly rate of randomisation, per centre: 1.6
Number of eligible participants who were not randomised because of setting preference: 10 participants; six refused due to lack of confidence in home delivery and four due to not wanting to impose on loved ones
Did it appear that all eligible patients were invited to participate? NR
Withdrawals and dropouts: 10 dropouts; six died and four reported deterioration requiring change of treatment | Primary outcome(s): patient satisfaction
Other outcomes: costs, quality of life (FLIC, MADRS), Hamilton Anxiety Scale
Quality of life and anxiety results NR, no response to author contact
Qualitative data reported? No
Economic evaluation? Yes
Type of economic evaluation: CEA
Currency (price year): US$ (1998) converted using purchasing power parities
Economic perspective: societal
Comments: care administered by external organisation Soins et Santé. Trial was terminated early because 95% of the first 52 patients expressed a preference for home administration of chemotherapy. The authors assumed that there were no costs for administration in the outpatient setting. Of outcomes listed for the trial, only costs were reported in this study |
Main reference: Rischin et al. 2000,32 full published paper
Linked references: King et al. 2001,54 letters to editor
Design: RCT (crossover)
Country: Australia
Recruitment period: February 1996 to March 1997
Number of recruiting centres: one
Assessment time points: after one treatment in each setting | Key characteristics of recruited population:
Inclusion criteria: patients aged ≥ 18 years, who had not received chemotherapy in the preceding 12 months, whose planned first two treatments were identical, and who lived in an area that was geographically suitable for treatment at home
Median age: around 60 years
Gender: 5/20 (25%) male
Cancer type: breast 10/20 (50%); colon 8/20 (40%); non-Hodgkin’s lymphoma 1/20 (5%); pancreatic 1/20 (5%)
Treatment intention: NR
Chemotherapy used: cyclophosphamide, methotrexate and 5-fluorouracil ± prednisolone [CMF(P)] 50%; 5-FU ± folinic acid or levamisole 45%; cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) 5% | Setting details:
Home: a chemotherapy nurse specialists who also worked in the chemotherapy day ward at the hospital administered all home chemotherapy treatments
Hospital (outpatient): chemotherapy administered by hospital chemotherapy nurse specialist. No further details reported
Preparation of chemotherapy: NR | Target sample size: 20
Number actually randomised: 25
Estimated monthly rate of randomisation: 1.8
Number of eligible participants who were not randomised because of setting preference: seven patients wanted home treatment only and 12 were ‘overlooked’
Did it appear that all eligible patients were invited to participate? No: 12 patients were overlooked in the recruitment stage (no further details were provided). In addition, patients were selected from patients registered on the chemotherapy-in-the-home program, for which eligibility criteria were NR
Withdrawals and dropouts: in the ‘hospital first’ arm three patients withdrew – one patient did not go on to receive chemotherapy, one received chemotherapy at home and one decided to have all chemotherapy in hospital after the first treatment
In the ‘home first’ arm, two patients withdrew: one person did not go on to receive any chemotherapy, and one patient had a change of chemotherapy regimen due to toxicity after cycle 1 | Primary outcome(s): patient preferred site for remaining treatments
Other outcomes: patient preference; patient satisfaction; complications; costs
Qualitative data reported? Yes
Economic evaluation? Yes
Type of economic evaluation: CEA
Currency (price year): AU$ NR
Study perspective: hospital
Comments: all eligible patients were ‘registered on the chemotherapy in the home program’. It appears that home chemotherapy was already an option outside of the trial setting. The targeted trial population seems to exclude those patients more likely to prefer the hospital setting
Only one treatment per setting was studied |
Main reference: Stevens et al. 2006,33 full published paper
Linked references: full published paper Stevens et al. 2006;55 full published paper Stevens et al. 2004;56 editorial104
Design: RCT (crossover)
Country: Canada
Recruitment period: NR
Number of recruiting centres: one
Assessment time points: baseline, 3 months, 6 months (prior to crossover) and then at 9 months (first assessment after crossover) and 12 months | Key characteristics of recruited population:
Inclusion criteria: children age 2–16 years of age, diagnosed with acute lymphoblastic leukaemia, being treated by standard protocol in the greater metropolitan area of the study
Exclusion criteria: children with other major congenital illnesses and those who did not have a patent central venous catheter
Age: NR
Gender: male 22/29 (75.9%)
Phase of chemotherapy: III 1/29 (3.4%) interim maintenance; IV 4/29 (13.8%) reinduction; V 24/29 (82.8%) maintenance
Treatment intention: curative
Chemotherapy used: intrathecal methotrexate, intravenous cyclophosphamide, vincristine, intravenous methotrexate, cytosine arabinoside (Ara C) | Setting details:
Home: some chemotherapy drugs were delivered in hospital for safety reasons; these included intrathecal methotrexate, intravenous cyclophosphamide, and vincristine. These drugs were delivered by standard protocol. Intravenous methotrexate and Ara C were delivered in patients’ homes by a trained community health services agency nurse. Blood samples were taken at a community laboratory the day prior to administration of chemotherapy. The primary oncology nurse was the main support nurse
Hospital (outpatient): patients received chemotherapy by standard hospital protocol. Blood samples were taken during scheduled visits
Preparation of chemotherapy: home – chemotherapy drugs were prepared by a community pharmacy and delivered to patients’ homes at pre-arranged times | Target sample size: 22
Number actually randomised: 29
Estimated monthly rate of randomisation: not possible to calculate
Number of eligible participants who were not randomised because of setting preference: 21 eligible patients declined to participate; 16 preferred hospital treatment; three preferred to keep home as a safe haven; two provided no reason
Did it appear that all eligible patients were invited to participate? Yes
Withdrawals and dropouts:
Home followed by hospital chemotherapy: two discontinued (relapse)
Hospital followed by home chemotherapy: four discontinued (two withdrew, two relapse). No reason was given for withdrawals | Primary outcome(s): patient quality of life was measured using the POQOLS questionnaire, and the Child Behaviour Checklist was used to measure social/psychological interactions of children
Other outcomes: caregiver burden as measured with the Caregiving Burden Scale; adverse events; costs
Qualitative data reported? Yes
Economic evaluation: yes
Economic evaluation type: CEA
Currency (price year): $CAN NR
Economic perspective: societal
Comments |
