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High BMI Associated With Worse Quality of Life in Breast Cancer Patients Receiving Radiation Therapy
Poster Viewing Abstracts S607
Volume 87 Number 2S Supplement 2013 related to replacing difficult words with words used in common language to make it easier to read for the participants. Some questions in English EPIC could not be translated literally to Punjabi as the meaning was lost in translation. Punjabi version also required four FT and BT revisions compared to one revision in Chinese. The overall process took four months for Punjabi and three months for Chinese. Sixteen Punjabi patients were approached to date; only eight agreed to participate; we completed three sixty-minute interviews. Most participants preferred home interviews. Punjabi speaking participants were not used to completing surveys and instructions have to be provided clearly using an interpreter. Family member, if present, often interrupted and affected participant’s response. Translators also tend to overstep their roles, indirectly affecting the interview. Lastly, although there was no concern for linguistic adaptation, participants have expressed cultural hesitation when answering sexual domain questions. Conclusions: Translation and validation of the EPIC questionnaire is labor intensive. We encountered unexpected cultural related problems during the process, such as interpreter interference and family member interruptions. More problems and their solutions will be presented at the conference as the project progresses to its validation phase. Author Disclosure: T. Lee: None. S. Singh-Carlson: None. G. Oshan: None. W. Kwan: None.
3056 High BMI Associated With Worse Quality of Life in Breast Cancer Patients Receiving Radiation Therapy P. Fang, K. Tan, A. Troxel, R. Rengan, G. Freedman, and L. Lin; University of Pennsylvania, Philadelphia, PA Purpose/Objective(s): Obesity has been associated with greater acute toxicity with definitive radiation therapy (RT) for breast cancer and gynecological malignancies. Higher BMI has previously been associated with breast cancer treatment-related lymphedema and inferior disease specific survival. We hypothesized that treatments may differentially impact quality of life (QOL) depending on patients’ baseline characteristics. The purpose of this study is to use patient-reported health related quality of life (HRQOL) to examine impact of body mass index (BMI) on breast and gynecologic cancer patient QOL during RT. Materials/Methods: Women with breast and gynecologic malignancies were prospectively enrolled on an IRB approved clinical trial to assess HRQOL. HRQOL surveys were obtained at baseline, during, and 3 months after RT using validated measures: EuroQol (EQ5D), Functional Assessment of Cancer Therapy General (FACT-G), and MD Anderson Symptom Inventory (MDASI). Linear regressions were used to assess for association between BMI and QOL measures including fatigue, self-rated health, and FACT-G scores. Mixed effects models were used to analyze effect of BMI on QOL over time. Results: One hundred eighty-three breast and 58 gynecologic cancer patients were enrolled, and 140 breast and 41 gynecologic patients completed all assessments. Higher BMI was associated with worse QOL for breast cancer patients across time. Before treatment, every unit increase in BMI was associated with worse fatigue of 0.11 (p Z 0.007) and worse self-rated health of -0.68 (p Z 0.019, 0-100 scale). During treatment, every unit increase in BMI was associated with worse FACT-G score of -0.7 (p Z 0.0054, 0-108 scale), poorer ability to perform usual activities 0.028
Poster Viewing Abstract 3057; Table
(p Z 0.0004), and worse fatigue of 0.11 (p Z 0.01). On the MDASI, higher BMI was associated with worse pain, nausea, appetite, drowsiness, vomiting, mood, greater interference with relationships, walking, and enjoyment of life on treatment, in follow-up or both (p < 0.05). Mixedeffects models indicate that BMI is associated with different trajectories of functional well-being and fatigue over time (p Z 0.046, 0.047). BMI was not significantly associated with any QOL outcomes in gynecologic cancer patients. Conclusions: Higher BMI was associated with poorer QOL in breast cancer patients treated with RT before, during, and after treatment. Our results suggest that supportive therapies, such as weight loss programs, physical therapy or lymphedema therapy, targeted at this population at higher risk for worse QOL during treatment should be considered. We did not find that BMI had a significant effect on QOL during treatment in Gyn cancer patients. Further research is needed to determine if this difference is due to baseline patient or treatment factors or due to smaller patient number. Author Disclosure: P. Fang: None. K. Tan: None. A. Troxel: None. R. Rengan: None. G. Freedman: None. L. Lin: None.
3057 Cancer Treatment Consent Forms Are Still Difficult to Read H. Wagner, H. Mackley, J. Crites, and C. Naret; Penn State Hershey Cancer Institute, Hershey, PA Purpose/Objective(s): Obtaining informed consent, whether for routine medical care or clinical research, requires that, among other things, patients understand the regimen to which they are consenting. The readability of consent documents has long been recognized as one important factor in the patient’s understanding the procedures to which they are consenting. Efforts have been made to simplify the readability of consent documents, typically to that readily comprehensible at the eighth grade level. With the increasing complexity of cancer treatment and length of consent documents, we have reviewed the issue of reading complexity of these documents, realizing that this is only one of the components leading to obtaining informed consent from patients. Materials/Methods: Adult consent forms were obtained from a sample of consent forms currently in use for standard medical oncology and radiation oncology procedures at Penn State Hershey Medical Center and a number of our community affiliates. We also examined several forms used for patients consenting to participate in clinical trials. Text for each form was transcribed into a common word processing format and analyzed using public domain reading complexity tools for a variety of readability metrics (www.editcentral.com/gwt1/EditCentral.html). Results: Representative results are shown below: Conclusions: None of the forms analyzed meets the goal of eighth grade readability and a number of them exceed it to a marked degree. Forms developed for clinical research seem to better approach this goal. Continued attention both to readability as well as patient understanding and remembrance of the procedure or regimen they have consented to is in order. This is key as we move into increasingly complex personalized medicine with its great potential for both individual benefit and risk. Author Disclosure: H. Wagner: None. H. Mackley: None. J. Crites: None. C. Naret: None.
Consent form readability
Consent document
Flesh reading ease
Flesh-Kincaid grade level
Gunning Fog index
SMOG index
Length (pages)
Comments
Rad Onc 1 Rad Onc 2 Rad Onc 3 Rad Onc 4 Rad Onc Research 1 Phase 3 Rad Onc Research 2 Phase 1-2 Rad Onc Research 3 Phase 3 Med Onc 1 Med Onc 2
39.1 44.7 48.7 57.0 62.6 67.5 65.2 58.1 56.7
14.4 12.2 12.3 9.4 10.1 8.5 9.0 9.2 9.7
19.0 16.5 16.4 13.6 14.0 12 12.7 12.9 13.2
16.0 14.3 14.1 12.3 12.2 10.9 11.4 11.9 12.1
2 6 1 2 15 16 10 3 4
All sites All sites All sites All sites Lung Lung SBRT Breast Lung Hodgkin Lymphoma
Volume 87 Number 2S Supplement 2013 related to replacing difficult words with words used in common language to make it easier to read for the participants. Some questions in English EPIC could not be translated literally to Punjabi as the meaning was lost in translation. Punjabi version also required four FT and BT revisions compared to one revision in Chinese. The overall process took four months for Punjabi and three months for Chinese. Sixteen Punjabi patients were approached to date; only eight agreed to participate; we completed three sixty-minute interviews. Most participants preferred home interviews. Punjabi speaking participants were not used to completing surveys and instructions have to be provided clearly using an interpreter. Family member, if present, often interrupted and affected participant’s response. Translators also tend to overstep their roles, indirectly affecting the interview. Lastly, although there was no concern for linguistic adaptation, participants have expressed cultural hesitation when answering sexual domain questions. Conclusions: Translation and validation of the EPIC questionnaire is labor intensive. We encountered unexpected cultural related problems during the process, such as interpreter interference and family member interruptions. More problems and their solutions will be presented at the conference as the project progresses to its validation phase. Author Disclosure: T. Lee: None. S. Singh-Carlson: None. G. Oshan: None. W. Kwan: None.
3056 High BMI Associated With Worse Quality of Life in Breast Cancer Patients Receiving Radiation Therapy P. Fang, K. Tan, A. Troxel, R. Rengan, G. Freedman, and L. Lin; University of Pennsylvania, Philadelphia, PA Purpose/Objective(s): Obesity has been associated with greater acute toxicity with definitive radiation therapy (RT) for breast cancer and gynecological malignancies. Higher BMI has previously been associated with breast cancer treatment-related lymphedema and inferior disease specific survival. We hypothesized that treatments may differentially impact quality of life (QOL) depending on patients’ baseline characteristics. The purpose of this study is to use patient-reported health related quality of life (HRQOL) to examine impact of body mass index (BMI) on breast and gynecologic cancer patient QOL during RT. Materials/Methods: Women with breast and gynecologic malignancies were prospectively enrolled on an IRB approved clinical trial to assess HRQOL. HRQOL surveys were obtained at baseline, during, and 3 months after RT using validated measures: EuroQol (EQ5D), Functional Assessment of Cancer Therapy General (FACT-G), and MD Anderson Symptom Inventory (MDASI). Linear regressions were used to assess for association between BMI and QOL measures including fatigue, self-rated health, and FACT-G scores. Mixed effects models were used to analyze effect of BMI on QOL over time. Results: One hundred eighty-three breast and 58 gynecologic cancer patients were enrolled, and 140 breast and 41 gynecologic patients completed all assessments. Higher BMI was associated with worse QOL for breast cancer patients across time. Before treatment, every unit increase in BMI was associated with worse fatigue of 0.11 (p Z 0.007) and worse self-rated health of -0.68 (p Z 0.019, 0-100 scale). During treatment, every unit increase in BMI was associated with worse FACT-G score of -0.7 (p Z 0.0054, 0-108 scale), poorer ability to perform usual activities 0.028
Poster Viewing Abstract 3057; Table
(p Z 0.0004), and worse fatigue of 0.11 (p Z 0.01). On the MDASI, higher BMI was associated with worse pain, nausea, appetite, drowsiness, vomiting, mood, greater interference with relationships, walking, and enjoyment of life on treatment, in follow-up or both (p < 0.05). Mixedeffects models indicate that BMI is associated with different trajectories of functional well-being and fatigue over time (p Z 0.046, 0.047). BMI was not significantly associated with any QOL outcomes in gynecologic cancer patients. Conclusions: Higher BMI was associated with poorer QOL in breast cancer patients treated with RT before, during, and after treatment. Our results suggest that supportive therapies, such as weight loss programs, physical therapy or lymphedema therapy, targeted at this population at higher risk for worse QOL during treatment should be considered. We did not find that BMI had a significant effect on QOL during treatment in Gyn cancer patients. Further research is needed to determine if this difference is due to baseline patient or treatment factors or due to smaller patient number. Author Disclosure: P. Fang: None. K. Tan: None. A. Troxel: None. R. Rengan: None. G. Freedman: None. L. Lin: None.
3057 Cancer Treatment Consent Forms Are Still Difficult to Read H. Wagner, H. Mackley, J. Crites, and C. Naret; Penn State Hershey Cancer Institute, Hershey, PA Purpose/Objective(s): Obtaining informed consent, whether for routine medical care or clinical research, requires that, among other things, patients understand the regimen to which they are consenting. The readability of consent documents has long been recognized as one important factor in the patient’s understanding the procedures to which they are consenting. Efforts have been made to simplify the readability of consent documents, typically to that readily comprehensible at the eighth grade level. With the increasing complexity of cancer treatment and length of consent documents, we have reviewed the issue of reading complexity of these documents, realizing that this is only one of the components leading to obtaining informed consent from patients. Materials/Methods: Adult consent forms were obtained from a sample of consent forms currently in use for standard medical oncology and radiation oncology procedures at Penn State Hershey Medical Center and a number of our community affiliates. We also examined several forms used for patients consenting to participate in clinical trials. Text for each form was transcribed into a common word processing format and analyzed using public domain reading complexity tools for a variety of readability metrics (www.editcentral.com/gwt1/EditCentral.html). Results: Representative results are shown below: Conclusions: None of the forms analyzed meets the goal of eighth grade readability and a number of them exceed it to a marked degree. Forms developed for clinical research seem to better approach this goal. Continued attention both to readability as well as patient understanding and remembrance of the procedure or regimen they have consented to is in order. This is key as we move into increasingly complex personalized medicine with its great potential for both individual benefit and risk. Author Disclosure: H. Wagner: None. H. Mackley: None. J. Crites: None. C. Naret: None.
Consent form readability
Consent document
Flesh reading ease
Flesh-Kincaid grade level
Gunning Fog index
SMOG index
Length (pages)
Comments
Rad Onc 1 Rad Onc 2 Rad Onc 3 Rad Onc 4 Rad Onc Research 1 Phase 3 Rad Onc Research 2 Phase 1-2 Rad Onc Research 3 Phase 3 Med Onc 1 Med Onc 2
39.1 44.7 48.7 57.0 62.6 67.5 65.2 58.1 56.7
14.4 12.2 12.3 9.4 10.1 8.5 9.0 9.2 9.7
19.0 16.5 16.4 13.6 14.0 12 12.7 12.9 13.2
16.0 14.3 14.1 12.3 12.2 10.9 11.4 11.9 12.1
2 6 1 2 15 16 10 3 4
All sites All sites All sites All sites Lung Lung SBRT Breast Lung Hodgkin Lymphoma