1. Survivorship in Women With Ovarian Cancer
GEMSTONE Educational Module
Last Update: April 9, 2018
GEMSTONE, a committee of ovarian cancer experts, provided direction and approval of the material in this educational resource. TESARO, Inc. provided writing and organizational support to GEMSTONE in the generation of this material.

2. Module Objectives
Review cancer survivorship care and guidelines for patients with ovarian cancer
Discuss the rationale for current examination practices and surveillance testing
Provide survivorship resources for patients and healthcare providers

3. Module Outline Introduction to Survivorship Care
Surveillance After Therapy
Distress Management Tools
Long-Term and Late Effects
Warning Signs of Recurrence
Management of Menopausal Symptoms
Patient Survivorship Care Resources
Summary and Unresolved Questions

4. Introduction to Survivorship Care

5. Survivorship Is a Key Component of Cancer Care Trajectory
The Institute of Medicine (IOM) defines survivorship care as beginning at the completion of primary cancer treatment1
However, evolving paradigms require providers to engage with survivorship from initiation of cancer treatment to engender optimal posttreatment health outcomes1
Survivorship Care2
Cancer-free survival
Recurrence/ second cancer
Start here
Managed chronic or intermittent disease
Treatment with intent to cure
Diagnosis and staging
Progression on Treatment
Palliative treatment
Death
1. Supportive care along the survivorship trajectory. In: Committee on the State of the Science in Ovarian Cancer Research; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine. Ovarian Cancers: Evolving Paradigms in Research and Care. Washington, DC: National Academies Press. books/NBK367609/. Published April 25, Accessed February 21, Delivering cancer survivorship care. In: Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: National Academies Press; 2006:190.

6. DETECTION / SURVEILLANCE
IOM Identifies 4 Essential Components of Posttreatment Survivorship Care
DETECTION / SURVEILLANCE
of recurrent cancers, new cancers, and late effects of cancer and its treatment
INTERVENTION
for the long-term and late effects of cancer and its treatment
PREVENTION
of recurrent and new cancers and other late effects
COORDINATION
among providers to ensure that all survivors’ health needs are met
IOM, Institute of Medicine.
Supportive care along the survivorship trajectory. In: Committee on the State of the Science in Ovarian Cancer Research; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine. Ovarian Cancers: Evolving Paradigms in Research and Care. Washington, DC: National Academies Press. Published April 25, Accessed February 21, 2018.

7. Surveillance After Therapy

8. Surveillance in Patients With Ovarian Cancer Remains a Critical Need
Stage of disease at diagnosis is a factor in determining a patient’s risk for recurrence1
Although relative survival has improved for all stages of ovarian cancer, a lack of accurate screening tools results in 60% of patients being diagnosed with stage III/IV disease2,3
Risk of Recurrence (%)
Stage of Disease at Diagnosis
10%
30%
70%–90%
90%–95%
Approximately 25% of patients with early-stage disease and >80% of patients with advanced disease will experience recurrence following primary therapy, even with achievement of initial complete response3
1. Ovarian Cancer Research Fund Alliance. Recurrence. Accessed February 23, National Cancer Institute. SEER Cancer Stat Facts: Ovarian Cancer. Revised April Accessed February 20, Salani R, et al. Gynecol Oncol. 2017;146(1):3-10.

9. Goals of Follow-Up Surveillance for Detection of Recurrent Disease
Impact Survival Outcomes
Balance Benefits and Pitfalls for Patients
Both monitoring for disease recurrence and treatment should translate to decreased morbidity
Disease monitoring may result in negative psychological impact on patients
Remain Cost Effective
Ensure Clinical Effectiveness
Effective surveillance plans should aim to reduce excessive costs and unnecessary use of resources for conducting surveillance testing
Adherence to recommended guidelines should minimize unnecessary testing while providing optimal surveillance
Salani R, et al. Gynecol Oncol. 2017;146(1):3-10.

10. Focusing on Certain Priority Symptoms Can Improve Recurrent Ovarian Cancer Care
Data from 497 women with recurrent ovarian, fallopian, or primary peritoneal cancer from the GOG-0259 trial were evaluated for patient-reported priority symptoms using the Symptom Representation Questionnaire
The analysis identified 18 core symptoms that should be assessed among patients with recurrent ovarian cancer to achieve more proactive and personalized care:
Pain
Anxiety
Fatigue
Sleep disturbance
Peripheral neuropathy
Constipation
Hair loss
Memory dysfunction
Abdominal bloating
Nausea
Drowsiness
Depression
Lack of appetite
Mood swings
Weight gain
Sexual concerns
Palmar-plantar erythrodysesthesia
Lymphedema
Blevins Primeau AS. Priority Symptoms Identified in Recurrent Ovarian Cancer. Oncology Nurse Advisor. oc/article/644415/. Published March 16, Accessed February 23, 2018.

11. Strong Evidence Demonstrates Benefits of Physical Activity Among Survivors
Studies have demonstrated that:
Individualized exercise plans can improve fatigue, anxiety, depression, self-esteem, happiness, and QoL in cancer survivors
Tailored exercise routines may reduce risk of recurrence and increase survival rates
Providers should discuss barriers to engaging in physical activity with their patients, which may include the following (depicted to the right):
Fatigue
Neuropathy
Pain
Financial
Nausea
Lymphedema
Psychosocial
Amputation
QoL, quality of life.
American Cancer Society. Cancer Treatment & Survivorship Facts & Figures survivorship-facts-and-figures/cancer-treatment-and-survivorship-facts-and-figures pdf. Published Accessed February 23, 2018.

12. Follow-Up Recommendation Intervals
Updated SGO Recommendations Provide a Detailed Surveillance Plan for Ovarian Cancer
Individualized patient plans should consist of a thorough assessment of symptoms and physical and pelvic examinations until the ideal surveillance strategy is determined
Follow-Up Recommendation Intervals
Time from completion of primary therapy (years)
0–2 years
2–3 years
3–5 years
>5 years
Symptom review and examination
3–4 months
4–6 months
6 months
Yearlya
Pap test/cytology
Not indicated
CA-125
Optional
Radiographic imagingb
Insufficient data to support routine use
Recurrence suspectedc
CT scans or PET/CT scans
CA-125 testing
a May be followed by a gynecologic oncologist or generalist. b May include chest X-ray, PET/CT scans, MRI, ultrasound. c Based on symptoms, examination, or CA-125 level.
CA, cancer antigen; CT, computed tomography; MRI, magnetic resonance imaging; Pap, Papanicolaou; PET, positron emission tomography; SGO, Society of Gynecologic Oncology.
Salani R, et al. Gynecol Oncol. 2017;146(1):3-10.

13. Current Recommendations
Physical Examinations Represent a Key Component of Monitoring for Recurrence
Gaps and Limitations
Reproducibility is low and may not detect other common sites of recurrence
Such as retroperitoneal lymph nodes, upper abdominal organs, or lungs
Physical examination alone may not be sufficient in certain patients
Current Recommendations
Follow-up visits every 3–4 months for the first 2 years
Followed by visits every 4–6 months for years 2–3, then every 6 months for years 3–5, then yearly
Review of symptoms and physical examination (bimanual pelvic and rectovaginal) are important parts of follow-up care, since 26%–50% of recurrences occur within the pelvis
Salani R, et al. Gynecol Oncol. 2017;146(1):3-10.

14. Current Recommendations
Serum Biomarker Surveillance With CA-125 May Identify Patients Earlier in Their Recurrence
Sensitivity and specificity for CA-125 levels to detect disease recurrence range from 62% to 94% and 91% to 100%, respectively1
Patients should be counseled regarding the advantages and limitations of serum biomarker surveillance with CA-1252
Current Recommendations
Gaps and Limitations
SGO: Measurement of CA-125 is optional1
National Comprehensive Cancer Network® (NCCN®): For patients with prior chemotherapy and partial or complete remission, and who then have serial increases in CA-125a, recommended options include enrollment in a clinical trial, delaying treatment until clinical relapse, or immediate treatment for recurrent disease3,b
Elevated CA-125 may also be found in other cancers, and monitoring has been associated with significant distress and anxiety2
A randomized, controlled trial of early vs delayed treatment of recurrent ovarian cancer revealed no significant survival advantage to early treatment (HR 0.98, 95% CI 0.80–1.20, p=0.85)4
a Patients should have imaging studies if clinically indicated and tumor molecular testing prior to treatment for biochemical relapse. b Recommendation of immediate treatment for recurrent disease is based on lower-level evidence with NCCN consensus that the intervention is appropriate (category 2B).
CA, cancer antigen; CI, confidence interval; HR, hazard ratio; NCCN, National Comprehensive Cancer Network; OS, overall survival; SGO, Society of Gynecologic Oncology.
1. Salani R, et al. Gynecol Oncol. 2017;146(1): Fleming ND, et al. Gynecol Oncol. 2011;121(2): Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer V © National Comprehensive Cancer Network, Inc All rights reserved. Accessed April 9, To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Rustin GJS, et al. Lancet. 2010;376(9747):

15. What Is Role of Radiographic Imaging in Detection of Recurrent Disease?
Radiographic imaging is best reserved as a supplement to abnormalities in physical examination, CA-125 levels, or symptoms
CT Scans
MRI Scans
Ultrasound
PET/CT Scans
Limitation
May lack the ability to detect a small volume of disease
Increased costs limit use; functional approaches may improve accuracy
Not typically used due to user variability and limited visibility
Only slightly more sensitive compared to CT scans in patients with normal CA-125 levels
Sensitivity
40%–93%
62%–91%
45%–85%
45%–100%
Specificity
50%–98%
40%–100%
60%–100%
CA, cancer antigen; CT, computed tomography; MRI, magnetic resonance imaging; PET, positron emission tomography.
Salani R, et al. Am J Obstet Gynecol. 2011;204(6):

16. Distress Management Tools

17. Cancer-Related Distress Can Manifest Through a Variety of Symptoms in Patients
Distress is an unpleasant experience of a psychological, social, spiritual, and/or physical nature that can make it more challenging to cope with cancer, its symptoms, and its treatment
NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®):
Expected Distress Symptoms
Fear and worry about future
Concerns about illness
Sadness about loss of usual health
Anger, feeling out of control
Poor sleep
Poor appetite
Poor concentration
Preoccupation with thoughts of illness and death
Concerns with disease or treatment side effects
Concerns about social role (ie, as a parent)
Spiritual/existential concerns
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © 2018 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data become available. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

18. Distress Can Occur at Any Point During a Patient’s Cancer Journey
NCCN Guidelines® recommend that distress should be recognized, monitored, documented, and treated at all stages of disease, as well as in all settings
NCCN Guidelines: Patients at Increased Risk for Distress
History of psychiatric disorder or substance use disorder
Severe comorbid illnesses
History of depression/suicide attempt
Social issues (including younger age, living alone, young or dependent children, and history of abuse)
Cognitive impairment
Spiritual/religious concerns
Communication barriers
Uncontrolled symptoms
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © 2018 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data become available. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

19. Active Communication Can Help Reduce Distress in Survivors
Experts in survivorship and distress management have obtained education, training, and credentials to conduct evaluations and provide treatment
Survivors may be referred to the following specialists, depending on their needs:
Nurses
Social Workers
Psychologists
Psychiatrists
Chaplains
Nurses are often the first to detect and screen for distress
Social workers play a role in addressing practical and psychosocial problems
Psychologists can provide a range of services, including treatment for mental health issues and cognitive problems
Psychiatrists are specialized medical doctors who are trained to assess the physical and mental aspects of mental health
Chaplains are certified to care for issues like grief, guilt, loss of faith, and spiritual concerns
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © National Comprehensive Cancer Network, Inc All rights reserved. Accessed February 23, To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

20. Distress May Limit a Patient’s Self-Care and Worsen Their Health
NCCN Guidelines recommend that patients undergo clinical assessment (which may include clinical interviews and validated scales/screeners for anxiety and depression) if there is clinical evidence of moderate to severe distressa
NCCN Guidelines: Periods of Increased Vulnerability
Finding a suspicious symptom
End of treatment
During a diagnostic workup
Admission to/discharge from hospital
Finding out the diagnosis
Transition to survivorship
Learning about genetic/familial cancer risk
Medical follow-up and surveillance
Awaiting treatment
Treatment failure
Change in treatment modality
Recurrence/progression or advanced cancer
Significant treatment-related complication(s)
End of life
a See slide 22 for more information about the Distress Thermometer.
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © 2018 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data become available. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

21. Distress Screening Tools Are Effective in Identifying a Patient’s Psychosocial Needs
Screening tools prompt patients to respond to one or more verbal statements or questions
Hand-held devices, interactive voice responses, and internet-based programs can also be used in addition to paper-based survey screening tools
Help detect patient stress
Provide detailed evaluations
Allow for better distress management
Help improve patient self-care
May lead to better health outcomes
SCREENING TOOLS
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © National Comprehensive Cancer Network, Inc All rights reserved. Accessed February 26, To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

22. Complementary Screening Tools Can Be Used for Detecting Distress
Distress Thermometer is a well- known screening tool
Problem List is completed alongside the Distress Thermometer 10 9 8 7 6 5 4 3 2 1
YES NO
Practical Problems
Physical Problems 
Child care
Appearance
Housing
Bathing/dressing
Insurance/financial
Breathing
Transportation
Changes in urination
Work/school
Constipation
Treatment decisions
Diarrhea
Eating
Family Problems
Fatigue
Dealing with children
Feeling swollen
Dealing with partner
Fevers
Ability to have children
Getting around
Family health issues
Indigestion
Memory/concentration
Emotional Problems
Mouth sores
Depression
Nausea
Fears
Nose dry/congested
Nervousness
Pain
Sadness
Sexual
Worry
Skin dry/itchy
Loss of interest in usual activities
Sleep
Substance use
Spiritual/Religious Concerns
Tingling in hands/feet
Extreme
Distress No
Distress
Other Problems:
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V © National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data become available. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

23. Resources to Manage Distress Should Be Varied Based on Patient’s Needs
Spirituality and religion may be related to better mental health
Chaplains can provide support to patients experiencing feelings like grief, guilt, and hopelessness
Cancer Education
Learning about cancer and its treatment may reduce patient distress
Patient navigator programs are a useful resource for patients
Chaplaincy Care
Practical problems
Illness, food, money, work, school, language, and caregiving
Psychosocial problems
Wide range from worsening QoL to conflicts within the patient’s family
Psychoeducation
Medicine
Psychotherapy
Substance use disorder treatment
Complementary & integrative therapies
Exercise
Social Work & Counseling
Mental Health Services
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management V and NCCN Guidelines for Patients® Distress V © National Comprehensive Cancer Network, Inc All rights reserved. Accessed February 26, To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

24. Long-Term and Late Effects

25. Both the Disease and Its Treatment Can Affect Every Aspect of a Patient’s Life
Late effects are unrecognized toxicities that are absent at the end of therapy and manifest months to years later as previously unseen injuries are unmasked
Long-term effects are complications of treatment, that begin during treatment and continue beyond the end of treatment, which impact a patient’s well-being
Some late and long-term effects:
Financial
Financial hardship
Job lock or loss
Employment and insurance discrimination
Psychosocial
Poor quality of life
Fear of recurrence
Poor self-esteem
Anxiety and depression
Body-image disturbances
Altered intimacy
Relationship difficulties
Impact on family dynamics
Social isolation
Altered spirituality
Physical
Second malignancies
Cardiotoxicity
Acute organ toxicities
Congestive cardiac failure
Neurocognitive deficits
Infertility
Premature menopause
Sexual impairment
Chronic fatigue
Pain syndromes
Aziz NM, et al. Semin Radiat Oncol. 2003;13(3):

26. Warning Signs of Recurrence

27. Advancing Disease May Lead to Additional Physical Symptoms
Potential Cause
Management Considerations
Inability to have bowel movement or pass gas, abdominal pain, cramps, nausea, vomiting, distention
Malignant bowel obstruction1
Surgical
Decompression: nasogastric/gastric intubation
Medical: opioids, antispasmodics, antiemetics, antisecretory agents, corticosteroids
Distention, anorexia and early satiety, extreme fatigue
Ascites2
Drainage
1. Roeland E, et al. Curr Oncol Rep. 2009;11(4): Courtney A, et al. J Vasc Interv Radiol ;19(12): 27

28. Management of Menopausal Symptoms

29. Hormone Replacement Therapy Can Relieve Menopausal Symptoms in Patients With Ovarian Cancer
Management of menopausal symptoms is important for improving QoL1
HRT is the delivery of estrogen ± progesterone to replace the ovarian production of hormones disrupted by spontaneous or induced menopause2
Induced Menopause1
Definition
Cessation of menstruation following bilateral oophorectomy or iatrogenic ablation of ovarian function due to chemotherapeutic treatment or pelvic radiation
Characterized by
A sudden onset of symptoms of increased severity compared to spontaneous or natural menopause
Adverse health outcomes
Cardiovascular disease, osteoporosis, cognitive impairment
Menopausal symptoms of estrogen deficiency
Vasomotor flashes, vaginal dryness, fatigue, mood changes
Management
Generally HRT
Common practice to avoid for hormone-sensitive tumors
HRT, hormone replacement therapy; QoL, quality of life.
1. Del Carmen MG, et al. Gynecol Oncol. 2017;146(2): Saeaib N, et al. Cochrane Database Syst Rev ;(2):CD

30. Patient Survivorship Care Resources

31. Survivorship Care Plan & Self-Care Plan Survivorship Calendar
SGO Has Developed Useful Resources for Survivors to Guide Next Steps After Treatment
Cancer survivors have several tools at their disposal to use in conjunction with information provided by their physician and/or cancer care team
Survivorship Care Plan & Self-Care Plan
Information Cards
Survivorship Calendar
Treatment Summary
Society of Gynecologic Oncology. Survivorship Toolkit. toolkit/. Accessed February 23, 2018.

32. Advanced Nurse Practitioners Play a Key Role in Providing Survivorship Care
APN Role
Considerations
Developing care plans
Ensure content is accurate
Provide comprehensive survivorship information that is evidence based
Access NCCN, ACS, and ASCO Survivorship Care Guidelines; communicate with treating physicians on specifics
Maintain communication with healthcare team
Survivorship clinic visit
Provide education
Follow-up schedule
Late and long-term effects
Recurrence prevention
General health promotion strategies
Resources
Coordination and communication of care
Clarification of roles of healthcare team (oncologists vs PCP)
Coordinate appointments
Provide support
Screen for supportive needs and initiate referral as needed
Tailor/adapt survivorship care plan based on holistic patient assessment
Barriers to transitioning to survivorship care
Patient readiness to learn
Financial status
Social support
ACS, American Cancer Society; APN, advanced practice nurse; ASCO, American Society of Clinical Oncology; NCCN, National Comprehensive Cancer Network; PCP, primary care provider.
Sun V, et al. J Adv Pract Oncol. 2015;6(1):64-70.

33. Group Interventions Can Address Many Cancer-Related Issues and Provide Emotional Support
Patients may choose to participate in support groups comprised of survivors of various stages of treatment and allow them to hear about the experiences of others living with ovarian cancer1
Patient participation in a support group for women recently diagnosed with ovarian cancer can provide multiple categories of experiences2
Listening, talking, comparing, and laughing
Sharing knowledge and giving advice
Providing hope, care, consolation, power, encouragement, support, understanding, relief, normality, etc
Reducing loneliness
Strengthening connections
PATIENTS ARE IN THE SAME BOAT
An exchange of informational support
A platform for emotional support
A sharing of experiences and emotions
1. Referenced with permission from the NCCN Guidelines for Patients® Ovarian Cancer V © National Comprehensive Cancer Network, Inc All rights reserved. Accessed February 9, To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Ahlberg K, et al. Oncol Nurs Forum. 2006;33(4):E53-61.

34. Summary and Unresolved Questions

35. Module Summary
Survivorship is an essential component of ovarian cancer care1
Multifaceted surveillance strategies are required to ensure early detection of recurrent disease2
Increased communication with patients can lead to decreased patient distress, better detection of recurrence, and improved QoL3
QoL, quality of life.
1. Supportive care along the survivorship trajectory. In: Committee on the State of the Science in Ovarian Cancer Research; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine. Ovarian Cancers: Evolving Paradigms in Research and Care. Washington, DC: National Academies Press. Published April 25, Accessed February 21, Sun V, et al. J Adv Pract Oncol. 2015;6(1): McCorkle R, et al. CA Cancer J Clin. 2011;61(1):50-62.

36. Unresolved Questions
What are the unique survivorship care needs for women with ovarian cancer?
How do the needs differ for women without active symptoms compared to women living with chronic illness?
What data are available on long-term (>10 years post- diagnosis) survivors?
What interventions beyond exercise (eg, psychosocial therapy) are correlated with survivorship benefit?

37. GEMSTONE
GEMSTONE, a committee of ovarian cancer experts, provided direction and approval of the material in this educational resource. TESARO, Inc. provided writing and organizational support to GEMSTONE in the generation of this material.
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