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Health-Related Quality of Life in Cancer Clinical Trials

Health-Related Quality of Life in Cancer Clinical Trials

Over the past 15 years, research into the health-related quality of life (HRQOL) of cancer patients has expanded dramatically. We have seen the development of a variety of instruments to assess both global HRQOL as well as cancer-specific symptoms. These instruments have been validated in a variety of populations. Many of the instruments have been translated into multiple languages. We have also seen the development of instruments to evaluate HRQOL in children and in adults with low literacy levels. We have learned how to integrate HRQOL questions into cancer clinical trials and how to facilitate the collection of QOL data from patients and their families. We are now beginning to evaluate interventions to maintain and enhance HRQOL among cancer patients and cancer survivors.

Biostatistical research has also progressed. We are now able to target clinically meaningful differences in HRQOL and identify the appropriate sample sizes. We know how to deal with data that are missing at random or not, whether from questions left blank or assessments not done at specified times.

The National Cancer Institute (NCI) has an ongoing HRQOL Working Group, comprised of staff members from the Divisions of Cancer Control and Population Sciences, Cancer Prevention, and Cancer Treatment and Diagnosis, with responsibility for QOL and outcomes research in cancer patients. The mission of this group includes the exchange of information as well as the promotion of research in HRQOL. To this end, the National Institutes of Health (NIH) plans to hold a Consensus Development Conference on management of depression, nausea, pain, and other cancer-related symptoms in 2002. In addition, the NCI has organized an HRQOL Intergroup Committee, which will bring together representatives from the Clinical Trials Cooperative Groups and Community Clinical Oncology Program (CCOP) research bases with an interest in HRQOL. The NCI is also working with the Food and Drug Administration (FDA) to see how measures of clinical benefit might be used in the drug approval process.

Part I of this series, which will itself be presented in two parts (concluding next month), focuses on HRQOL questions in cancer treatment trials conducted as part of NCI-sponsored research through the Clinical Trials Cooperative Groups, other research consortia, and multicenter trials. We have included the HRQOL instruments used and the HRQOL end points under study. Part II will focus on investigator-initiated HRQOL research. Part III will address HRQOL research as part of cancer prevention trials.

NCI staff and extramural investigators have worked together closely to develop this portfolio of treatment trials. We have learned that HRQOL research must be integrated into the larger cancer treatment trial if we hope to collect the QOL data successfully. The collection of HRQOL data is labor-intensive, requiring substantial commitments of time from both patients, their families, and the research team. Therefore, we have encouraged the Cooperative Groups to include HRQOL assessments only in clinical trials where there is an HRQOL hypothesis that will add to the existing body of knowledge, will generate hypotheses for future studies, or stimulate a change in clinical practice.

Recommendations have been made to limit the number of instruments and times at which patients are surveyed, and to evaluate QOL only in as many patients as needed to answer the QOL question. In most large phase III trials, for example, the HRQOL end points require a smaller sample size than the treatment end points. We have also encouraged the Cooperative Groups to consider toxicity and response data as surrogate measures for HRQOL in many phase I and II clinical trials.

We should emphasize several ongoing issues of importance in HRQOL research. First, we must move more quickly from descriptive studies to trials in which we evaluate interventions to preserve or restore HRQOL. We must learn whether the available instruments give meaningful assessments of HRQOL in all cancer patients, including the elderly, the disabled, and those from the broad variety of sociocultural backgrounds that comprise the population of the United States. We must determine how best to integrate HRQOL into decisions on cancer treatment. Finally, we need to know how to integrate assessments of HRQOL with other cancer outcome measures, such as cost and utility.

A selection of currently open or approved, NCI-sponsored, phase I-III clinical trials that employ QOL instruments are shown below. Information about these studies can be obtained from the principal investigators or other contacts listed for each trial or from Edward L. Trimble, MD, MPH at the Cancer Therapy Evaluation Program (CTEP), trimblet@ctep.nci.nih.gov or (301) 496-1196.

Note: The QOL instruments are indicated in italics at the bullet point "QOL Instruments/End Points,"

Group or Lead Group: American College of Radiology Imaging Network (ACRIN)
Protocol Number: ACRIN-6651 (active; phase: other)
Title: Diagnostic Study of Computed Tomography and Magnetic Resonance Imaging in the Pretreatment Evaluation of Patients With Invasive Cervical Cancer
QOL Instruments/End Points: Patient Questionnaire: Time to take diagnostic tests, time away from work, discomfort caused by tests, how invasive or intrusive the test was perceived to be, and posttest effects the same day
Protocol Status: Active
Contact: Hedvig Hricak, American College of Radiology Imaging Network, (212) 639-7284
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: Cancer and Leukemia Group B (CALGB)
Protocol Number: CLB-9687 (active; phase II; adult)
Title: Phase II Study of the Role of Salvage Prostatectomy after Radiation Failure in Patients With Prostate Carcinoma
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Prostate: Overall QOL; pain and fatigue; physical, social, emotional, and functional well-being; additional concerns about prostate cancer
Bladder, Bowel, and Sexual Functioning Inventory (C-466) (QOL assessment only required after a salvage prostatectomy): Urinary control/incontinence, bowel habits, crampy pain, sexual function and sexual satisfaction
Protocol Status: Active
Contact: Gary D. Steinberg, Cancer and Leukemia Group B, (773) 564-5272; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: Cancer and Leukemia Group B (CALGB)
Protocol Number: CLB-9782 (active; phase II; adult)
Title: Phase II Study of Flutamide and Finasteride in Patients with Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Adenocarcinoma of the Prostate
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Prostate: Physical, functional, social and emotional well-being, and satisfaction with treatment relationships; supplemented by additional questions on sexual functioning
Protocol Status: Active
Contact: Joel Picus, Cancer and Leukemia Group B, (314) 747-1367; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: Cancer and Leukemia Group B (CALGB)
Protocol Number: CLB-119802 (approved; phase II; adult)
Title: Phase II Study of Fluoxetine With Gemcitabine and Cisplatin in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
QOL Instruments/End Points: European Organization for Research and Treatment of Cancer (EORTC) Core Questionnaire (QLQ-C30): General physical symptoms, physical functioning, fatigue/malaise, social functioning, psychological stress; specific end points for strenuous or normal physical activities, leisure activities, shortness of breath, pain, need for rest, weakness, appetite, nausea, vomiting, constipation, diarrhea, concentration, tense, worry, irritable, depressed, memory, interference with family life or social activities, overall health

  • EORTC QOL Questionnaire: Lung (LC-13): Asks additional questions specific to lung cancer and treatment-related symptoms

  • Rand Mental Health Inventory 17: Anxiety, depression, general positive affect, emotional ties, loss of behavioral emotional control

  • Fatigue Severity Scale: Amount of fatigue experienced and interference with other areas of functioning in a patient’s life

  • CALGB QOL Assessment Summary (C-419): Collective information on completeness of the QOL assessment, and reasons for missed/incomplete assessment

Protocol Status: Active
Contact:
Richard L. Schilsky, Cancer and Leukemia Group B, (773-834-3914)
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: CALGB
Protocol Number: CALGB-9840 (active; phase III; adult)
Title: Phase III Randomized Study of Paclitaxel Via One Hour Infusion Every Week Versus Three Hour Infusion Every 3 Weeks With or Without Trastuzumab (Herceptin) in Patients With Inoperable, Recurrent, or Metastatic Breast Cancer With or Without Overexpression of HER2-Neu
QOL Instruments/End Points: CALGB QOL Assessment Summary (C-419): Collective information on completeness of the QOL assessment, and reasons for missed/incomplete assessment

  • EORTC QOL Questionnaire (QLQ-C30): General physical symptoms, physical functioning, fatigue/malaise, social functioning, psychological stress; specific end points for strenuous or normal physical activities, leisure activities, short of breath, pain, need for rest, weakness, appetite, nausea, vomiting, constipation, diarrhea, concentration, tense, worry, irritable, depressed, memory, interference with family life or social activities, overall health

  • EORTC QOL Questionnaire (Breast Module): Dry mouth, changed ability to taste, eyes painful/irritated/watery, hair loss, feel ill, hot flashes, headaches, feel physically less attractive, feel less feminine, sexual interest, pain, skin problems

  • Functional Assessment of Cancer Therapy/GOG Neurotoxicity Scale: Hand/feet numbness/tingling, joint pain, muscle cramps, weakness, trouble hearing, dexterity, walking ability

  • CALGB: QOL Utility Assessment (C-460): Activity (main), daily living, state of health, support received, and outlook on life

  • CALGB Changes in Function (C-616): Physical condition, emotional state, enjoyment of social life, overall QOL

  • CALGB: Center for Epidemiological Studies (CES)—Depression (CES-D, Short Form): Depression, restless sleep, crying spells, sadness, feel disliked

  • Spirituality Subscale (C-613): Spiritual beliefs: peaceful, reason for living, sense of purpose, sense of harmony, comfort/strength from faith

Protocol Status: Active
Contact:
Andrew D. Seidman, Cancer and Leukemia Group B, (212) 636-5875 (CTSU Investigators: see footnote)*; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU) investigators with scientific questions about this trial should contact the principal investigator at the sponsoring Cooperative Group. CTSU investigators interested in enrolling patients on this trial through the CTSU should contact the CTSU General Information line for further information at 888 823-5923 or ctsucontact@westat.com

Group or Lead Group: COG
Protocol Number:
CCG-2961 (active; phase III; pediatric)
Title: Phase III Randomized Study for Untreated Pediatric Acute Myelogenous Leukemia and Myelodysplastic Syndromes: Intensively Timed Induction Chemotherapy, Followed By Consolidation With the Same Chemotherapy vs Fludarabine, Cytarabine, and Idarubicin, Followed By Intensification Either With High Dose Cytarabine and Asparaginase With or Without Subsequent Interleukin-2 or With Allogeneic Bone Marrow Transplantation
QOL Instruments/End Points: Lansky Play-Performance Scale for Children: Parent assesses play activity

  • Karnofsky Performance Scale: Global functioning in terms of degree of mobility, ability to maintain employment, live at home, and care for oneself

Protocol Status: Active
Contact:
Beverly J. Lange, Children's Cancer Group, (215) 590-2249; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: COG
Protocol Number: A9952 (CCG-9952) (active; phase III; pediatric)
Title: Phase III Study of Carboplatin and Vincristine Versus Thioguanine, Procarbazine, Lomustine, and Vincristine in Children With Progressive Low Grade Astrocytoma
QOL Instruments/End Points: Child Depression Inventory: Parents’ observations of social development, self help, gross motor, fine motor, expressive language, language comprehension, letters and numbers, general development

  • Lansky Play-Performance Scale for Children: Parent assesses play activity

  • Karnofsky Performance Scale: Global functioning in terms of degree of mobility, ability to maintain employment, live at home, and care for oneself

  • Vineland Adaptive Behavior Scales: Communication, daily living skills, and socialization

  • Child Behavior Checklist: Parent/guardian checklist on behavioral problems and social competence scales

  • Bayley Mental Scales for Infant Development and Bayley Motor Scale of Infant Development: Two scales for developmental status based on cognitive and motor tasks

  • Wechsler Preschool and Primary Scales of Intelligence: Revised: Assesses verbal and nonverbal cognitive skills in ages 2 to 5 11/12

  • Weschsler Intelligence Scale for Children-III (WISC-III): Global intellectual capacity based on verbal and nonverbal cognitive skills for ages 6 to 16 11/12

Protocol Status: Active
Contact:
Joann Ater, Children's Cancer Group, Pediatric Oncology Group, (713) 792-6665; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: COG and National Institutes of Health Pediatric Oncology Branch (NCIPOB)
Protocol Number: T98-0011 (active; phase II; pediatric)
Title: Phase II Study of Intravenous Lobradimil and Carboplatin in Patients With Childhood Brain Tumors
QOL Instruments/End Points: Impact of Pediatric Illness Scale (Age-Appropriate Questionnaire): impact of diseases and treatment on children’s behavior
Protocol Status: Active
Contact:
Katherine Warren, Center for Cancer Research, (301) 435-4683; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: COG
Protocol Number: POG-9407 (active; phase II; pediatric)
Title: Phase II Pilot Study of Induction Intensification and Allogeneic Bone Marrow Transplantation in Infants With Newly Diagnosed Acute Lymphoid Leukemia
QOL Instruments/End Points: Bayley Mental Scales for Infant Development and Bayley Motor Scale of Infant Development: Two scales for developmental status based on cognitive and motor tasks

  • Vineland Adaptive Behavior Scales: Communication, daily living skills, and socialization

  • Child Behavior Checklist: Parent’s rating of 99 problem items; six syndromes are derived

  • Wechsler Preschool and Primary Scales of Intelligence: Global intellectual capacity based on verbal and nonverbal cognitive skills; uses norms based on standard sample representative of gender, age, parent education levels, region, and ethnicity

  • Beery Developmental Test of Visual-Motor Integration: Test of visual-motor abilities involving copying geometric forms of increasing complexity

Protocol Status: Active
Contact:
ZoAnn Eckert Dreyer, Children's Oncology Group, (832-824-4200); for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: COG; Intergroup
Protocol Number: POG-P9934 (active; phase III; pediatric)
Title: Phase III Study of Cyclophosphamide, Vincristine, Cisplatin, and Etoposide Followed By Second-Look Surgery and Focal Conformal Radiotherapy in Children With Nonmetastatic Medulloblastoma or Posterior Fossa Primitive Neuroectodermal Tumor
QOL Instruments/End Points: Bayley Scales of Infant Development - II: Assesses mental and motor developmental functioning in infants

  • Wechsler Preschool and Primary Scale—Revised: Assesses intellectual functioning in preschool-age children (ages 36-72 months). Verbal and performance IQ scores are computed

  • Wechsler Intelligence Scales for Children-III (WISC-III): Global intellectual capacity based on verbal and nonverbal cognitive skills; uses norms based on standard sample representative of gender, age, parent education levels, region and ethnicity

  • Connors’ Continuous Performance Test (CPT): Evaluates selective and sustained attention, reaction time and impulsivity (computerized)

  • Ages and Stages Questionnaire: Parent assesses developmental achievements in the domains of gross motor, fine motor, problem solving, personal, social and communication

Protocol Status: Active
Contact:
David Ashley, Children's Oncology Group, 01161-39345-5522 (CTSU Investigators: see footnote)*; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU) investigators with scientific questions about this trial should contact the principal investigator at the sponsoring Cooperative Group. CTSU investigators interested in enrolling patients on this trial through the CTSU should contact the CTSU General Information line for further information at 888 823-5923 or ctsucontact@westat.com

Group or Lead Group: Eastern Cooperative Oncology Group (ECOG)
Protocol Number: E-1Z95 (active; phase II; adult)
Title: Phase II Study of Flecainide for the Treatment of Chronic Neuropathic Pain
QOL Instruments/End Points: Wisconsin Brief Pain Inventory: Improvement in pain and pain manage-
ment measured prior to and during protocol duration for patients with chronic pain
Protocol Status: Active
Contact: John Middleton, Raritan Bay Medical Center, (732) 324-5007; Denis B. Fitzgerald, Riverview Medical Center, (732) 530-8666
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG
Protocol Number: E-3899 (approved; phase II; adult)
Title: Phase II Randomized Study of Mitoxantrone, Estramustine, and Vinorelbine Versus Isotretinoin, Interferon alfa, and Paclitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer
QOL Instruments/End Points: Functional Assessment of Cancer Therapy (FACT)—Prostate: Overall QOL; pain and fatigue; physical, social, emotional and functional well being; additional concerns about prostate cancer

  • Trial Outcome Index: Combines scores from FACT for physical and functional well-being with prostate cancer subscale

  • Schwartz Cancer Fatigue Scale: Physical and subjective fatigue

  • Wisconsin Brief Pain Inventory: Pain intensity, pain relief, interference with functioning use of pain medications

Protocol Status: Active
Contact: Robert S. DiPaola, Eastern Cooperative Oncology Group, (732) 235-7469; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG
Protocol Number: E-1697 (active; phase III; adult)
Title: Phase III Randomized Adjuvant Study of High Dose Interferon Alfa-2b Therapy in Patients With Stage II and III Melanoma
QOL Instruments/End Points: Quality-Adjusted Time Without Symptoms and Toxicity: Quality-adjusted survival analysis to assess rapidly developing and long-term changes in QOL
Protocol Status: Active
Contact: Sanjiv S. Agarwala, Eastern Cooperative Oncology Group, (412) 648-6507; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG
Protocol Number: E1897 (active; phase III; adult)
Title: A Phase III Randomized Trial of Either M-VAC or Paclitaxel + Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High Risk for Relapse
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Bladder: Pre- and posttreatment total QOL: physical, social, emotional and functional well being; bladder cancer-specific concerns
Protocol Status: In review
Contact: Jean MacDonald, (617) 632-3610

Group or Lead Group: ECOG; Intergroup
Protocol Number: E-1A95 (active; phase III; adult)
Title: Phase III Randomized Study of Vincristine, Doxorubicin, and Dexamethasone (VAD) With Or Without PSC 833 in Relapsed or Refractory Multiple Myeloma
QOL Instruments/End Points: Brief Pain Questionnaire—ECOG: Measure improvement in subjective pain and palliation of symptoms

  • Analgesic Scale: Diary and symptoms

  • ECOG Performance Status: Physical function

Protocol Status: Active
Contact:
Robert L. Comis, Eastern Cooperative Oncology Group, (215) 789-3645; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG; Intergroup
Protocol Number: E-1D96 (active; phase III; adult)
Title: Phase III Randomized Study of Paclitaxel Versus Doxorubicin HCL Liposome in Patients with Advanced AIDS-Associated Kaposi's Sarcoma
QOL Instruments/End Points: Functional Assessment of HIV Infection: Total QOL, physical well being, social-family functional well being, relationship with doctor, emotional well being, disease specific concerns including metastases, chemotherapy, pain, edema, and change in appearance and disease status
Protocol Status: Active
Contact: Jamie Hayden Von Roenn, Eastern Cooperative Oncology Group, (312) 695-6180
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG
Protocol Number: E-4897 (active; phase III; adult)
Title: Phase III Randomized Study of Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (M-VAC) Versus Carboplatin and Paclitaxel in Patients With Advanced Carcinoma of the Urothelium
QOL Instruments/End Points: Functional Assessment of Cancer Therapy (FACT)—Bladder: Pre- and posttreatment total QOL: physical, social, emotional and functional well being; bladder cancer-specific concerns

  • Total Outcome Index: Combines scores from FACT for physical and functional well-being with bladder subscale

Protocol Status: Active
Contact:
Robert L. Comis, Eastern Cooperative Oncology Group, (215) 789-3645 (CTSU Investigators: see footnote)*; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG; Multicenter
Protocol Number: JHD06 (phase III; adult)
Title: A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy vs ABVD Alone in the Treatment of Early Stage Hodgkin’s Disease
QOL Instruments/End Points: EORTC Core Questionnaire 33: Strenuous/light physical activities, shortness of breath, pain, need for rest, difficulty sleeping, appetite, nausea, vomiting, constipation, diarrhea, tension, worry, depression, limitations or interference with home activites, work, family life and social activities, finanicial difficulties, overall physical condition/health/QOL, emotional state, social enjoyment, bladder control, rectal bleeding/pain, hot flashes, sex life
Protocol Status: In review
Contacts: Jean MacDonald, (617) 632-3610

Group or Lead Group: ECOG
Protocol Number: E-1996 (active; phase III; adult)
Title: Phase III Randomized Study of Epoetin Alfa With or Without Filgrastim (G-CSF) vs Supportive Therapy Alone in Patients With Myelodysplastic Syndrome
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—General + Uncertainty Subscale: Physical, social-family, emotional, and functional well-being; relationship with doctor

  • Functional Assessment of Cancer Therapy—Fatigue: Impact of fatigue on multiple aspects of QOL

  • Functional Assessment of Cancer Therapy—Spirituality: Spiritual beliefs: peaceful, reason for living, sense of purpose, sense of harmony, comfort/strength from faith (as per spirituality subscale)

Protocol Status: Active
Contact: Kenneth B. Miller, Eastern Cooperative Oncology Group, (617) 956-5144; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: ECOG
Protocol Number: E-2898 (approved; phase III; adult)
Title: Phase III Randomized Study of Interferon alfa-2b With or Without Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
QOL Instruments/End Points: Functional Assessment of Chronic Illness Therapy (FACIT-F): Physical, social/family, emotional and functional well-being; additional concerns specifically related to fatigue
Protocol Status: Active
Contact: Michael Steven Gordon, Eastern Cooperative Oncology Group, (602) 631-4610; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: GOG
Protocol Number: GOG-0179 (active; phase III; adult)
Title: Phase III Randomized Study of Cisplatin Versus Cisplatin Plus Topotecan Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) in Patients With Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Cervix: Physical, social-family, emotional and functional well-being; specific concerns about cervical cancer

  • Wisconsin Brief Pain Inventory: Pain management, intensity of pain, interference of pain with patient’s life

  • Uniscale: Visual analog scale for overall QOL

Protocol Status: Active
Contact: Harry J. Long, III, Gynecologic Oncology Group, (507) 284-4320; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: GOG
Protocol Number: GOG-LAP2 (active; phase III; adult)
Title: Phase III Randomized Study of Vaginal Hysterectomy and Bilateral Salpingo-Oophorectomy (BSO) Via Laparoscopy Versus Total Abdominal Hysterectomy and BSO Via Conventional Laparotomy Plus Pelvic and Para-Aortic Lymph Node Sampling in Patients With Stage I or IIA, Grade I-III Endometrial Cancer or Uterine Cancer
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—General: Physical, social/family, emotional and functional well-being; relationship with doctor; symptoms assessed include fever, constipation, diarrhea, and shortness of breath

  • Medical Outcomes Study—Physical Functioning Subscale (SF-36): activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities

  • Wisconsin Brief Pain Inventory: Pain management, intensity of pain, interference of pain with patient’s life

  • Fear of Relapse/Recurrence Scale (Kornblith) (only suitable for follow-up assessment): Beliefs and anxieties concerning disease recurring

  • Sexual Functioning Scale (GOG): Sexual response, pain during intercourse, fears about sexual relations

  • Body Image (GOG): Physical appearance: surgical scar and its effect upon feeling feminine, response of partner, and as a reminder of cancer treatment

Protocol Status: Active
Contact: Joan L. Walker, Gynecologic Oncology Group, (405) 271-8707; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: GOG
Protocol Number: GOG-9901 (active; phase: other; adult)
Title: Quality of Life Study in Patients with Previously Treated Ovarian Germ Cell Cancer
QOL Instruments/End Points: Cope (Coping Questionnaire): Ways of coping with life stressors

  • Impact of Event Scale: Feelings, thoughts, memories, and dreams about having cancer

  • Duke-UNC Functional Social Support Questionnaire: Assesses whether amount of family/social support is as much as patient would like for care, love/affection, talk, invitations, advice, help when sick in bed

  • Dyadic Adjustment Scale (Spanier): Marital stress: satisfaction, cohesion, consensus, expression of affection

  • Medical Outcomes Study Short Form 36 (MOS-36-SF): Activities of daily living: walking, climbing, stairs, bathing, dressing, and performance of physical activities, problems and interference with daily activities, how you feel, perceived health

  • Symptom Distress Scale: Overall level of fatigue, insomnia, pain, concentration, and outlook

  • Stressful Life Events Questionnaire: Personal meaning of stress from work lay off, retirement, marriage, marital problems, divorce, death or hospitalization of spouse, birth/adoption of child, death of family member/friend, jail, financial difficulties

  • Family APGAR: Satisfaction regarding family help, sharing problems, support wishes, affection/response to emotions

  • Sexual Activity Questionnaire: Sexual feelings and experiences

  • Center for Epidemilogical Studies— Depression (CES-D): Depression, restless sleep, crying spells, sadness, feel disliked

  • Positive and Negative Affect Scale (PANAS) (Watson): Life satisfaction and appreciation scales, and additional questions on whether the experience of cancer has helped growth or increased strength as an individual, had positive changes in life, causes feeling of anger or is upsetting to talk about

  • Posttraumatic Growth Inventory: Cancer specific life changes: life priorities, appreciation of value of life, self reliance, closeness to others, compassion, new opportunities, stronger religious faith, new interests

  • Integrative Cancer Experience Scale: How cancer has changed appreciation of life; concerns about recurrence of cancer

  • FACT Spirituality Subscale: Spiritual beliefs: peaceful, reason for living, sense of purpose, sense of harmony, comfort/strength from faith

  • Confidence Scale: Confidence in activities, situations or behaviors in which women with illness sometimes report difficulty: open discussion of illness, concentration, memory, exercise, fears, anger, request/accept help, personal goals, socialization

  • Illness Intrusiveness Scale: How illness or treatment has interfered with different aspects of life—diet, work, recreation, financial, relations, sex life, self-expression, community/civic involvement

Protocol Status: Active
Contact: Stephen D. Williams, Gynecologic Oncology Group, (317) 278-0070
Latest Information: http://cancernet.nci.nih.gov/

The remainder of this Clinical Trials Referral Resource will appear in next month’s issue of ONCOLOGY.

 
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