Alberta CancerBridges development of a care plan evaluation measure.

BACKGROUND: No standardized measures specifically assess cancer survivors' and healthcare providers' experience of Survivor Care Plans (scps). We sought to develop two care plan evaluation (cpe) measures, one for survivors (cpe-s) and one for healthcare providers (cpe-p), examine initial psychometric qualities in Alberta, and assess generalizability in Manitoba, Canada. METHODS: We developed the initial measures using convenience samples of breast (n = 35) and head and neck (n = 18) survivors who received scps at the end of active cancer-centre treatment. After assessing Alberta's scp concordance with Institute of Medicine (iom) recommendations using a published coding scheme, we examined psychometric qualities for the cpe-s and cpe-p. We examined generalizability in Manitoba, Canada, with colorectal survivors discharged to primary care providers for follow-up (n = 75). RESULTS: We demonstrated acceptable internal consistency for the cpe-s and cpe-p subscales and total score after eliminating one item per subscale for cpe-s, two for cpe-p, resulting in revised scales with four 7-item and 6-item subscales, respectively. Subscale scores correlated highly indicating that for each measure the total score may be the most reliable and valid. We provide initial cpe-s discriminant, convergent, and predictive validity using the total score. Using the Manitoba sample, initial psychometrics similarly indicated good generalizability across differences in tumour groups, scp, and location. CONCLUSIONS: We recommend the revised cpe-s and cpe-p for further use and development. Studies documenting the creation and standardization of scp evaluations are few, and we recommend further development of patient experience measures to improve both clinical practice and the specificity of research questions.

Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT.

BACKGROUND: Recent breast cancer treatment guidelines recommend that higher-risk premenopausal patients should receive ovarian function suppression (OFS) as part of adjuvant endocrine therapy. If chemotherapy is also given, it is uncertain whether to select concurrent or sequential OFS initiation. DESIGN AND METHODS: We analyzed 1872 patients enrolled in the randomized phase III TEXT and SOFT trials who received adjuvant chemotherapy for hormone receptor-positive, HER2-negative breast cancer and upon randomization to an OFS-containing adjuvant endocrine therapy, initiated gonadotropin-releasing-hormone-agonist triptorelin. Breast cancer-free interval (BCFI) was compared between patients who received OFS concurrently with chemotherapy in TEXT (n = 1242) versus sequentially post-chemotherapy in SOFT (n = 630). Because timing of trial enrollment relative to adjuvant chemotherapy differed, we implemented landmark analysis re-defining BCFI beginning 1 year after final dose of chemotherapy (median, 15.5 and 8.1 months from enrollment to landmark in TEXT and SOFT, respectively). As a non-randomized treatment comparison, we implemented comparative-effectiveness propensity score methodology with weighted Cox modeling. RESULTS: Distributions of several clinico-pathologic characteristics differed between groups. Patients who were premenopausal post-chemotherapy in SOFT were younger on average. The median duration of adjuvant chemotherapy was 18 weeks in both groups. There were 231 (12%) BC events after post-landmark median follow-up of about 5 years. Concurrent use of triptorelin with chemotherapy was not associated with a significant difference in post-landmark BCFI compared with sequential triptorelin post-chemotherapy, either in the overall population (HR = 1.11, 95% CI 0.72-1.72; P = 0.72; 4-year BCFI 89% in both groups), or in the subgroup of 692 women <40 years at diagnosis (HR = 1.13, 95% CI 0.69-1.84) who are less likely to develop chemotherapy-induced amenorrhea. CONCLUSION: Based on comparative-effectiveness modeling of TEXT and SOFT after about 5 years median follow-up, with limited statistical power especially for the subgroup <40 years, neither detrimental nor beneficial effect of concurrent administration of OFS with chemotherapy on the efficacy of adjuvant therapy that includes chemotherapy was detected. CLINICALTRIALS.GOV: NCT00066690 and NCT00066703.

Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors.

BACKGROUND: Survivorship care plans (scps) have been recommended as a way to ease the transition from active cancer treatment to follow-up care, to reduce uncertainty for survivors in the management of their ongoing health, and to improve continuity of care. The objective of the demonstration project reported here was to assess the value of scps for cancer survivors in western Canada. METHODS: The Alberta CancerBridges team developed, implemented, and evaluated scps for 36 breast and 21 head-and-neck cancer survivors. For the evaluation, we interviewed 12 of the survivors, 9 nurses who delivered the scps, and 3 family physicians who received the scps (n = 24 in total). We asked about satisfaction, usefulness, emotional impact, and communication value. We collected written feedback from the three groups about positive aspects of the scps and possible improvements (n = 85). We analyzed the combined data using qualitative thematic analysis. RESULTS: Survivors, nurses, and family physicians agreed that scps could ease the transition to survivorship partly by enhancing communication between survivors and care providers. Survivors appreciated the individualized attention and the comprehensiveness of the plans. They described positive emotional impacts, but wanted a way to ensure that their physicians received the scps. Nurses and physicians responded positively, but expressed concern about the time required to implement the plans. Suggestions for streamlining the process included providing survivors with scp templates in advance, auto-populating the templates for the nurses, and creating summary pages for physicians. CONCLUSIONS: The results suggest ways in which scps could help to improve the transition to cancer survivorship and provide starting points for larger feasibility studies.

Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy?

BACKGROUND: The role of chemotherapy in addition to combined endocrine therapy for premenopausal women with endocrine-responsive early breast cancer remains an open question, yet trials designed to answer it have repeatedly failed to adequately accrue. The International Breast Cancer Study Group initiated two concurrent trials in this population: in Premenopausal Endocrine Responsive Chemotherapy (PERCHE), chemotherapy use is determined by randomization and in Tamoxifen and Exemestane Trial (TEXT) by physician choice. PERCHE closed with inadequate accrual; TEXT accrued rapidly. METHODS: From 2003 to 2006, 1317 patients (890 with baseline data) were randomly assigned to receive ovarian function suppression (OFS) plus tamoxifen or OFS plus exemestane for 5 years in TEXT. We explore patient-related factors according to whether or not chemotherapy was given using descriptive statistics and classification and regression trees. RESULTS: Adjuvant chemotherapy was chosen for 64% of patients. Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative). Geography, patient age, tumor size and grade were also determinants, but degree of receptor positivity and human epidermal growth factor receptor 2 status were not. CONCLUSIONS: The perceived estimation of increased risk of relapse is the primary determinant for using chemotherapy despite uncertainties regarding the degree of benefit it offers when added to combined endocrine therapy in this population.

Comparison of polytetrafluoroethylene (PTFE) and dacron as long, small-diameter arterial grafts in dogs.

A canine model in which joined carotid arteries were anastomosed to 6-mm grafts (average length, 45 cm) of polytetrafluoroethylene (PTFE) or Dacron double velour and the grafts were anastomosed to the ligated distal abdominal aorta was used to study long-term graft patency. The 16 dogs with PTFE grafts and the 15 dogs with Dacron grafts were sacrificed at three-, six-, and 12-month intervals, or whenever a graft occluded. At three months, eight of 11 PTFE and 11 of 11 Dacron grafts were patent; at six months, two of three PTFE and three of three Dacron grafts were patent; at 12 months, one of two PTFE grafts and the one remaining Dacron graft were patent. All grafts were examined grossly and microscopically. The PTFE grafts showed increasing degrees of calcification and intimal fibrin deposition; the Dacron grafts had no calcification and less intimal fibrin deposition. The model was satisfactory for studying long, small-diameter vascular grafts, but PTFE was not found to be superior to Dacron in this study.

Duodenal patch grafting.

Loss of duodenal tissue around the pancreatic and common bile ducts presents a challenge to abdominal surgeons. Available methods to correct the problem include duodenojejunostomy, diamond duodenoplasty, serosal patching, mucosal pedicle patching from the ileum or jejunum, and gastric island patching. The choice of procedure must be tailored to the nature of the defect, the amount of tissue lost and the amount of peritoneal contamination. We believe that jejunal mucosal pedicle patching is a reasonable choice in most instances.

Expanded microporous polytetrafluoroethylene as canine arterial bypass or replacement graft.

Expanded microporous polytetrafluoroethylene (PTFE) has been used experimentally and clinically for small-vessel bypass or replacement grafting; the results vary widely. This study assessed short (4--cm) femoral and carotid artery replacement PTFE grafts and longer (12--cm) femoral artery bypass PTFE grafts that crossed a flexion crease. Pore size at the blood-graft interface ranged from 10 to 30 mu. At the end of three months, overall patency rate was 22%. No long bypass grafts remained patent. The pore size and type of anastomosis did not affect patency. The occlusion was always thrombotic, associated with fibrin at the suture line. Nine of the 20 short carotid grafts (45%) and five of 22 short femoral grafts (22%) remained patent. These poor results indicate that further experimental studies are needed before PTFE is used clinically when an alternative exists.