Intensive outpatient adjuvant therapy for breast cancer: results of dose escalation and quality of life.

1996 ◽  
Vol 14 (5) ◽  
pp. 1565-1572 ◽  
Author(s):  
S M Swain ◽  
J Rowland ◽  
K Weinfurt ◽  
C Berg ◽  
M E Lippman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Psychosocial Adjustment ◽  
Dose Escalation ◽  
Maximum Tolerated Dose ◽  
Physical Symptoms ◽  
Self Report ◽  
Dose Escalation Study

PURPOSE A dose-escalation study was conducted to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cyclophosphamide (CY) in combination with granulocyte colony-stimulating factor (G-CSF0 and doxorubicin (DOX) given every 2 weeks for eight cycles as outpatient adjuvant therapy for node-positive breast cancer. A pilot study to assess quality of life (QOL) was performed. PATIENTS AND METHODS From March 1991 to April 1993, 19 patients were entered. Patients received escalating doses of CY intravenously (i.v.) (1,000 mg/m2, 1,500 mg/m2, 2,000 mg/m2, or 2,500 mg/m2) with DOX 40 mg/m2, G-CSF 10 micrograms/kg/d on days 2 to 12, and mesna, every 2 weeks for eight cycles. QOL was measured by the Profile of Mood States (POMS), the Psychosocial Adjustment to Illness Scale-Self Report (PAIS-SR), and a 27-item QOL scale. RESULTS The CY dose of 2,500 mg/m2 every 2 weeks elicited toxicities that required dose reductions secondary to a combination of thrombocytopenia, hematuria, and anemia that required transfusion. The dose of 2,000 mg/m2 resulted in an acceptable toxicity profile. Ninety-two percent of cycles at the 2,000-mg/m2 dose were delivered on schedule and 77% without hospitalization. QOL assessments indicated high levels of distress measured by POMS in 47%, poor overall quality of life in 40%, and significant problems with physical symptoms in less than 27% of all patients for any given cycle. CONCLUSION A dose of CY at 2,000 mg/m2 can be administered every 2 weeks with DOX and G-CSF for eight cycles in the outpatient setting with manageable toxicity. The majority of women described levels of physical symptoms and emotional distress as tolerable during treatment.

scholarly journals Symptom Experience and Quality of Life of Patients with Breast Cancer Receiving Chemotherapy in Bangladesh

2016 ◽  
Vol 15 (2) ◽  
pp. 201-206
Author(s):  
Mosammat Shamsun Naher Begum ◽  
Wongchan Petpichetchian ◽  
Luppana Kitrungrote
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Medical Science ◽  
Well Being ◽  
Significant Negative Correlation ◽  
Moderate Level ◽  
Self Report ◽  
Symptom Experience ◽  
Breast Cancer Patients

Background: The present study was aimed to the relationships between symptom severity and distress and quality of life (QoL) of patients receiving chemotherapy for breast cancer.Objectives and methodology: A total number of 132 patients, attending both In-patient and Out-patient department and fulfilling the recruitment criteria were included in the study. A self-report questionnaire was used to collect data from the eligible participants by the primary investigator. The data were analyzed by using descriptive and inferential statistical tools. Results: On average, the participants of the study experienced seventeen symptoms with moderate level. The level of QoL of the participants was at moderate level (M=2.02, SD=0.39). Among all the subscales, the physical well-being had the lowest score and social well-being had highest score. Symptom experience and quality of life showed significant negative correlation. Conclusion: The patients with breast cancer would experience high symptoms during a 7-day period after receiving chemotherapy of the previous cycle. Nurses need to perform full measurement of multiple symptoms when care for breast cancer patients after the administration of chemotherapy.Bangladesh Journal of Medical Science Vol.15(2) 2016 p.201-206

scholarly journals Effect of different modalities of treatment on the quality of life of breast cancer patients in Egypt

1997 ◽  
Vol 3 (1) ◽  
pp. 68-81
Author(s):  
Fatma M. El Sharkawi ◽  
Mahmoud F. Sakr ◽  
Hoda Y. Atta ◽  
Hafez M. Ghanem
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Therapy ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Breast Cancer Therapy ◽  
Egyptian Women ◽  
The Impact

The impact of breast cancer therapy on the quality of life [QL] of Egyptian women was studied. Patients were divided into four groups:1:mastectomy alone;2:surgery plus radiotherapy;3:surgery plus chemotherapy;and 4:triple modality. The results revealed that all the four domains of QL of women having adjuvant therapy [groups 2, 3, or 4] were significantly altered compared to those who underwent mastectomy alone. Triple modality adversely affected global QL the most compared to radiotherapy or chemotherapy;radiotherapy had significantly less effect on QL compared to chemotherapy. Triple modality predicted the worst QL. QL measures should be incorporated with the traditional end points for evaluation of treatment and patients given health education on the effects of each therapy

Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer.

1998 ◽  
Vol 16 (4) ◽  
pp. 1380-1387 ◽  
Author(s):  
C Lindley ◽  
S Vasa ◽  
W T Sawyer ◽  
E P Winer
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Sexual Function ◽  
Cancer Patients ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Breast Cancer Patients ◽  
Systemic Adjuvant Therapy

PURPOSE To evaluate the quality of life (QOL) of breast cancer patients who survived 2 to 5 years following initiation of adjuvant cytotoxic and/or hormonal therapy and to characterize relationships between QOL and patient physical symptoms, sexual function, and preferences regarding adjuvant treatment. PATIENTS AND METHODS Eighty-six patients who had completed systemic adjuvant therapy for early-stage breast cancer between 1988 and 1991 were surveyed by written questionnaire and telephone interview. Sociodemographic information was obtained for each patient, and patients were asked to complete the Functional Living Index-Cancer (FLIC), the Symptom Distress Scale (SDS), the Medical Outcomes Study (MOS) Short Form 36 (SF-36), a series of questions regarding sexual function, and a survey about preferences for adjuvant therapy in relation to possible benefit. RESULTS The mean FLIC score among all patients was 138.3 (+/- 12.2), which suggests a high level of QOL. The reported frequency of moderate to severe symptoms was generally low (ie, < 15%), with fatigue (31.4%), insomnia (23.3%), and local numbness at the site of surgery (22.1%) occurring with greatest frequency. Patients reported a wide range of sexual difficulties. Preference assessment showed that more than 65% of patients were willing to undergo 6 months of chemotherapy for a 5% increase in likelihood of cancer cure. CONCLUSION Self-rated QOL in breast cancer patients 2 to 5 years following adjuvant therapy was generally favorable. Less than one third of patients reported moderate to severe symptoms. Selected aspects of sexual function appeared to be compromised. The majority of patients indicated a willingness to accept 6 months of chemotherapy for small to modest potential benefit.

scholarly journals Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial

2016 ◽  
Vol 34 (24) ◽  
pp. 2827-2834 ◽  
Author(s):  
Cecile A. Lengacher ◽  
Richard R. Reich ◽  
Carly L. Paterson ◽  
Sophia Ramesar ◽  
Jong Y. Park ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Usual Care ◽  
Stress Reduction ◽  
Breast Cancer Survivors ◽  
Physical Symptoms ◽  
Fear Of Recurrence ◽  
Effect Sizes ◽  
Fatigue Severity

Purpose The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. Patients and Methods A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. Results Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). Conclusion The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes.

Breast cancer nursing interventions and clinical effectiveness: a systematic review

2020 ◽  
Vol 10 (3) ◽  
pp. 276-286
Author(s):  
Raymond Javan Chan ◽  
Laisa Teleni ◽  
Suzanne McDonald ◽  
Jaimon Kelly ◽  
Jane Mahony ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Symptom Burden ◽  
Risk Of Bias ◽  
Self Report ◽  
Self Management ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

ObjectivesTo examine the effects of nurse-led interventions on the health-related quality of life, symptom burden and self-management/behavioural outcomes in women with breast cancer.MethodsCochrane Controlled Register of Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline and Embase databases were searched (January 1999 to May 2019) to identify randomised controlled trials (RCTs) and controlled before-and-after studies of interventions delivered by nurses with oncology experience for women with breast cancer. Risk of bias was evaluated using the revised Cochrane risk-of-bias tool for randomised trials. Intervention effects were synthesised by cancer trajectory using The Omaha System Intervention Classification Scheme.ResultsThirty-one RCTs (4651 participants) were included. All studies were at risk of bias mainly due to inherent limitations such as lack of blinding and self-report data. Most studies (71%; n=22) reported at least one superior intervention effect. There were no differences in all outcomes between those who receive nurse-led surveillance care versus those who received physical led or usual discharge care. Compared with control interventions, there were superior teaching, guidance and counselling (63%) and case management (100%) intervention effects on symptom burden during treatment and survivorship. Effects of these interventions on health-related quality of life and symptom self-management/behavioural outcomes were inconsistent.DiscussionThere is consistent evidence from RCTs that nurse-led surveillance interventions are as safe and effective as physician-led care and strong evidence that nurse-led teaching, guidance and counselling and case management interventions are effective for symptom management. Future studies should ensure the incorporation of health-related quality of life and self-management/behavioural outcomes and consider well-designed attentional placebo controls to blind participants for self-report outcomes.Protocol registrationThe International Prospective Register of Systematic Reviews (PROSPERO): CRD42020134914).

Yoga in women undergoing treatment for breast cancer: Impact on quality of life in a randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 527-527
Author(s):  
Nita S. Nair ◽  
Nishu Singh Goel ◽  
Rohini W Hawaldar ◽  
Shabina Siddique ◽  
Vani Parmar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Low Cost ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Complementary Therapy ◽  
Significant Difference

527 Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We propose to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (Study methodology details refer to NCT02161900). Methods: Women with non-metastatic BC were randomized to yoga and conventional exercise (YCE) versus conventional exercise only (CE) in addition to standard therapy. Over and above documentation of recurrence and death, QOL was assessed in these women using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the first interim analysis of QOL in 605 patients randomized to the study with atleast 1 year of follow up. The groups were balanced in both arms with respect to clinico-pathological factors. Results: At 6-9 mo (completion of adjuvant therapy), there was no significant difference in global QOL scores (p = 0.08), however 52% women on YCE showed an improvement from baseline compared to 42% in CE. At 18-21 mo emotional function scores were better in YCE (p = 0.002); with lesser systemic side effects in YCE arm (44% vs 56% p = NS). The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE (17.37vs22.22, p = 0.003) which was similar to that observed by BFI at 12-15 mo (1.6vs 2, p = 0.04). Also in YCE there was lower reporting of detriment in general activity (41%vs 59%) and mood (34%vs66%) (p = NS). In VPS at 12-15mo, the median scores for pain intensity (p = 0.042), pain on movement (p = 0.038), pain on mobilization (p = 0.008) were lower in YCE. Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores in YCE. Conclusions: Yoga did not show a significant difference in global QOL but had a major benefit reaching statistical significance in fatigue, emotional score and pain. Yoga is a low-risk, low-cost complementary therapy that may improve compliance to therapy by improving parameters that can affect day-to-day activity in women with breast cancer. Clinical trial information: NCT02161900.

Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.

1997 ◽  
Vol 15 (3) ◽  
pp. 974-986 ◽  
Author(s):  
M J Brady ◽  
D F Cella ◽  
F Mo ◽  
A E Bonomi ◽  
D S Tulsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Therapy ◽  
Functional Assessment ◽  
Performance Status ◽  
Well Being ◽  
Self Report ◽  
Sensitivity To Change ◽  
Validity And Reliability

PURPOSE This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.

Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRI

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19532-19532 ◽  
Author(s):  
L. Wagner ◽  
S. E. Lai ◽  
M. Aneja ◽  
P. Lorusso ◽  
R. Perez-Soler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Social Life ◽  
Symptom Burden ◽  
Physical Symptoms ◽  
Self Report ◽  
Antitumor Effects ◽  
Related Quality ◽  
The Impact ◽  
Skin Pain

19532 Background: Despite their beneficial antitumor effects, 75–87% patients who undergo EGFRI therapy develop dermatological toxicities (derm tox), including rash, paronychia, hair alterations, and pruritus. The purpose of this study was to develop a patient (pts) self-report questionnaire based on pts and expert (exp) input and to identify the most significant skin tox health-related quality of life (HRQL) factors. Methods: To generate the questionnaire, 20 pts with derm tox to EGFRIs and 12 expert clinicians (>50 treated pts) were asked interview questions and rated 62 items to assess the most bothersome aspects of derm tox and the impact on pts’ skin-specific HRQL. The questionnaire included items from the Skindex-29, a validated skin disease-specific HRQL questionnaire. Items were rated from 0 (not at all important) to 3 (extremely important) (range = 0–3) based on the items’ significance to patients’ HRQL. Both groups were also asked to circle 20 of the most concerning HRQL factors. Results: Eighteen pts and 11 exp completed the questionnaire. Symptoms reported frequently by both pts and exp that affected patients’ HRQL included painful (mean score 2.29 (pts), 2.70, (exp), burning (2.41 (pts), 2.70 (exp)), itchy (2.00 (pts), 2.20 (exp) skin, pain in fingers/toes (2.00 (pts), 2.40 (exp)) increased facial hair (1.93(pts), 1.70 (exp)). Both pts and exp also frequently reported that the patient’s skin condition makes them feel depressed (1.88 (pts), 2.60 (exp)) and makes work or hobbies difficult (2.00 (pts), 2.20 (exp)). The top three most concerning HRQL factors for pts were skin pain, burning and stinging, and irritation, while exp reported depression, skin pain, and derm tox affecting pts’ social life. Conclusions: These results document the trajectory of symptom burden and derm tox HRQL in EGFRI treated pts. These findings underscore that in addition to the psychosocial discomfort, physical symptoms impact HRQL. Further studies to validate the FAST-EGFRI, so that effects on HRQL of interventions against derm tox and differences between agents can be assessed are underway. No significant financial relationships to disclose.

Phase I dose-escalation study of AlphaMedix for targeted-alpha-emitter therapy of PRRT-naive neuroendocrine patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4117-4117
Author(s):  
Ebrahim Delpassand ◽  
Izabela Tworowska ◽  
Rouzbeh Esfandiari ◽  
Julien Torgue ◽  
Jason Daniel Hurt ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dose Escalation ◽  
Objective Response ◽  
Substantial Reduction ◽  
Tumor Burden ◽  
Dramatic Improvement ◽  
Dose Escalation Study ◽  
Recist 1.1 ◽  
Alpha Emitter

4117 Background: Peptide-receptor-radioligand-therapy (PRRT) has been shown to increase the progression-free-survival (PFS) of neuroendocrine patients, however the objective response rate is rather low. The targeted-alpha-emitter therapy (TAT) of NETs can increase the ORR and induce partial or complete tumor response. In this abstract, we present results of the safety and efficacy of AlphaMedix (212Pb-DOTAMTATE) done in PRRT-naïve patients with SSTR-expressing NETs (FDA IND 135150). Methods: The phase 1 dose escalation study (IND 135150) was designed according to a 3+3 dose-escalation scheme (30% increase of the dose in each subsequent cohort). We enrolled PRRT naïve subjects with biopsy-proven unresectable or metastatic SSTR-expressing NETs from different primary sites (midgut, rectal, pancreas, and lung) with at least one measurable lesion. Response to treatment was measured per RECIST 1.1 criteria and the effect on quality of life was measured with the EORTC-QLQ-C30 QOL questionnaire. Results: A total of 20 PRRT naïve subjects (10 men and 10 women; median age 60 ( range 27-80)) have been treated to date. 10 subjects in MAD4 cohort received at least three cycles of 212Pb-DOTAMTATE at the highest dose level of 67.6 µCi/kg/cycle. Of these, 6/10 subjects (60%) have completed all four-cycles of treatment. Radiographic evaluation of these six-MAD4 patients reveal an ORR in 5 out of 6 subjects (83.3%) per RECIST 1.1 criteria (1CR, 4PR, 1SD) in addition to a 100% response according to 68Ga-DOTATATE-PET/CT-imaging, defined as complete resolution of SSTR-positive lesions (CR) or Partial Response (PR) defined as resolution of most active lesions or substantially decreased SUV (>25%). No progression of disease was noted in the first six subjects enrolled in the MAD4 cohort who have completed treatment. All six-patients have 100% PFS up to 22 months (for the first 3-subjects in MAD4) and up to 19 months (next 3-patients). Except for mild-to-moderate, reversible hair loss, there were no other clinically significant drug related AE, or SAE. The most frequent AEs of any grade (> 4 subjects) reported include fatigue (35%), hyperglycemia (30%), lymphopenia (30%) alopecia (30%), and diarrhea (20%). Five grade 3 AEs were reported (back pain, dysarthria, dyspnea, acute kidney injury), no grade 4 AEs, and one grade 5 AE was reported. There was a significant improvement in the quality of life, reduction of pain, shortness of breath in the majority of subjects, with increase of energy. Conclusions: This F-I-H clinical study of AlphaMedix shows that PRRT with 212Pb is feasible, well tolerated, and provides substantial reduction in tumor burden to patients with unresectable, metastatic SSTR-expressing NETs. Dramatic improvement in tumor burden and a positive impact on quality of life were seen in all of the PRRT naïve subjects who AlphaMedix at the highest dose tested. Clinical trial information: NCT03466216.

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