PMID- 26457466
OWN - NLM
STAT- MEDLINE
DCOM- 20160513
LR  - 20211203
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
VI  - 122
IP  - 2
DP  - 2016 Jan 15
TI  - Validation of a short questionnaire to measure symptoms and functional 
      limitations associated with hand-foot syndrome and mucositis in patients with 
      metastatic renal cell carcinoma.
PG  - 287-95
LID - 10.1002/cncr.29655 [doi]
AB  - BACKGROUND: Hand-foot syndrome and mucositis/stomatitis are frequent adverse 
      events (AEs) of treatment with tyrosine kinase inhibitors in cancer therapy. 
      Quality-of-life instruments that measure the functional consequences of these AEs 
      are needed to assess the impact of therapeutic interventions and to guide patient 
      care. The Hand-Foot and Mucositis Symptom and Impact Questionnaire (HAMSIQ 
      [formerly the Supplementary Quality of Life Questionnaire]) was used in the 
      COMPARZ trial (Pazopanib vs Sunitinib in the Treatment of Locally Advanced and/or 
      Metastatic Renal Cell Carcinoma [national clinical trial no. NCT00720941]) and 
      the PISCES study (Patient Preference Study of Pazopanib vs Sunitinib in Advanced 
      or Metastatic Kidney Cancer [clinicaltrials.gov NCT01064310]) to assess 
      mouth/throat and hand/foot soreness symptoms and subsequent limitations in 
      patients receiving pazopanib or sunitinib for metastatic renal cell carcinoma. 
      The objective of the current analysis was to validate the HAMSIQ using data from 
      the PISCES study. METHODS: The HAMSIQ was administered in the PISCES study at 
      baseline and every 2 weeks over two 10-week periods to patients who were 
      receiving pazopanib or sunitinib. Data from the first 10-week period were used to 
      assess the feasibility, validity, and responsiveness of the HAMSIQ. RESULTS: In 
      total, >/=85% of 169 patients completed the HAMSIQ (excluding the item concerning 
      days off work). Correlations among items within the same limitation subscale 
      generally were high (Cronbach alpha >/= .80). HAMSIQ limitation scores differentiated 
      patients according to their baseline performance status and severity of soreness. 
      Small-to-moderate correlations were observed for the symptoms/limitation scores 
      and for changes from baseline scores between the HAMSIQ and the Functional 
      Assessment of Chronic Illness Therapy fatigue survey. The HAMSIQ demonstrated 
      responsiveness to changes in clinical status and the development of hand-foot 
      syndrome AEs over time. CONCLUSIONS: The HAMSIQ is a feasible, valid, reliable, 
      and responsive instrument for assessing the impact of hand-foot syndrome and 
      mucositis in patients receiving tyrosine kinase inhibitors. Cancer 
      2016;122:287-295. (c) 2015 American Cancer Society.
CI  - (c) 2015 American Cancer Society.
FAU - Lai, Jin-Shei
AU  - Lai JS
AD  - Department of Medical Social Sciences, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois.
FAU - Beaumont, Jennifer L
AU  - Beaumont JL
AD  - Department of Medical Social Sciences, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois.
FAU - Diaz, Jose
AU  - Diaz J
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Khan, Sadya
AU  - Khan S
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Cella, David
AU  - Cella D
AD  - Department of Medical Social Sciences, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois.
LA  - eng
SI  - ClinicalTrials.gov/NCT00720941
SI  - ClinicalTrials.gov/NCT01064310
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20151012
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Indazoles)
RN  - 0 (Indoles)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 0 (Sulfonamides)
RN  - 7RN5DR86CK (pazopanib)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Carcinoma, Renal Cell/drug therapy/pathology
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Hand-Foot Syndrome/*etiology/physiopathology/psychology
MH  - Humans
MH  - Indazoles
MH  - Indoles/*adverse effects/therapeutic use
MH  - Kidney Neoplasms/drug therapy/pathology
MH  - Lymph Nodes/*pathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Mucositis/*chemically induced/physiopathology/psychology
MH  - Neoplasm Invasiveness/pathology
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Pyrimidines/*adverse effects/therapeutic use
MH  - Pyrroles/*adverse effects/therapeutic use
MH  - Quality of Life
MH  - Risk Assessment
MH  - Sulfonamides/*adverse effects/therapeutic use
MH  - Sunitinib
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
OTO - NOTNLM
OT  - antiangiogenic therapy
OT  - hand-foot syndrome
OT  - health-related quality of life
OT  - metastatic renal cell carcinoma
OT  - mucositis
OT  - questionnaire
OT  - stomatitis
OT  - tyrosine kinase inhibitors
EDAT- 2015/10/13 06:00
MHDA- 2016/05/14 06:00
CRDT- 2015/10/13 06:00
PHST- 2015/02/18 00:00 [received]
PHST- 2015/07/08 00:00 [revised]
PHST- 2015/07/17 00:00 [accepted]
PHST- 2015/10/13 06:00 [entrez]
PHST- 2015/10/13 06:00 [pubmed]
PHST- 2016/05/14 06:00 [medline]
AID - 10.1002/cncr.29655 [doi]
PST - ppublish
SO  - Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.