Investigator-Initiated Health-Related Quality-of-Life Research

September 1, 2001

In part I of this series, we identified currently active clinical trials that include health-related quality-of-life (HRQOL) outcomes as a primary or secondary objective of the overall study (Trimble EL et al: ONCOLOGY 15:601-611, 2001). The goal of this

In part I of this series, we identified currently active clinical trials thatinclude health-related quality-of-life (HRQOL) outcomes as a primary orsecondary objective of the overall study (Trimble EL et al:ONCOLOGY 15:601-611, 2001). The goal of this list was to increasethe clinician’s awareness of, and referral of potentially eligible patients toongoing trials in this area.

Clinical Trials Referral Resource is designed to serve as a ready reference for oncologists to help identify clinical trials that might be suitable for their patients. We hope it will also enhance accrual to clinical trials by informing practicing oncologists of ongoing protocols. Currently in the United States less than 10% of eligible adult patients are entered into clinical trials. The result is a delay in answering important therapeutic and scientific questions and disseminating therapeutic advances to the general oncology community.

It should be emphasized that including a specific trial does not imply that it is more important than another trial. Among the criteria for selection are that the trial is addressing an important question and is not expected to close in the immediate future (less than 1 year), and that initial staging or laboratory tests required for patient eligibility are widely practiced and available. Information on other protocols can be accessed via Physician’s Data Query (PDQ).*

We emphasize that this is an attempt to encourage referral of patients to these trials. We are specifically not soliciting additional members for the cooperative groups, nor are we suggesting how practicing oncologists should be treating patients who are not in a study.

This month’s installment of Clinical Trials Referral Resource is devoted to investigator-initiated health-related quality-of-life research.

For patient entry information, see the individual trials.

* PDQ is a comprehensive database service provided by the National Cancer Institute’s International Cancer Information Center and Office of Cancer Communications for retrieval of cancer treatment information, including peer-reviewed statements on treatment options, supportive care, screening, and prevention; and an international clinical trials registry. For more information on PDQ, Internet access is available at http://cancernet.nci.nih.gov/pdqfull.html, or contact the Cancer Information Service offices (1-800-4-CANCER).

In part II, we provide a list ofinvestigator-initiated (R01 type) grants that address interventions to improveHRQOL or health outcomes among patients in active treatment or post-treatment.Because all of these studies are being conducted at specific sites or withpreviously identified samples, none are "open to accrual" from thegeneral oncology population. (In rare cases, a clinician may be able to enroll apatient because the study’s principal investigator is affiliated with or usingpatients from their cancer center or local region.)

Our intent in identifying these studies is fourfold. First, as a group theyillustrate the direction being taken in HRQOL research that is coming out of theindependent investigator community. In contrast to the cancer cooperativegroups, the HRQOL focused studies from the investigator-driven community areshifting away from descriptive research. Increasingly, they are proposing (andbeing funded) to develop and test the efficacy of interventions (both medicaland psychosocial/behavioral) to improve HRQOL. Over 50% of the HRQOL-related R01studies supported by the National Cancer Institute (NCI) now include anintervention component.

Second, by providing information on the different kinds of interventions indevelopment, clinicians and researchers may be stimulated to consider which ofthese interventions, if successful, might be suitable for phase IIItesting. One of the major barriers to behavioral/HRQOL research in the oncologysetting has been the failure to take successful intervention projects beyond thephase II pilot trial. For example, two meta-analyses have shown that anumber of behavioral interventions can improve psychosocial, and in some casesmedical, outcomes for treated patients,[1-2] yet phase III studies are not beingconducted.

Third, by providing information on these studies, we hope to encouragecollaborative research among investigators with common research goals. Whilefewer subjects are generally needed to evaluate HRQOL-related outcomes than drugtreatment outcomes, it is still rare for a single institution alone to be ableto accrue sufficient numbers in a timely manner.

Finally, as in part I, by including the specific instruments being evaluated,we hope to provide a resource for investigators who may be looking forappropriate assessment tools. In addition, this information may facilitate acomparison of data already collected with that gathered using the same orsimilar instruments being used to evaluate different treatments, populations, orfollow-up periods.

Fortunately, access to appropriate measurement tools is no longer asignificant barrier to advancing HRQOL research. The past decade has seen thegrowth of an increasing number of well-developed and reliable instruments thatpermit us to quantify the impact of cancer on patients’ quality, not merelylength, of survival.[3-5] It is no longer necessary, or even desirable, forresearchers to design assessment measures de novo for a given project. Withbroader use of common metrics, it will be possible to accurately evaluate theburden of cancer on the larger survivor population as well as our efforts toreduce this burden through clinical research, cancer practice, and health-carepolicy change.

A key to the many acronyms used in the following listings is provided at theend of this article.

Psychoeducational Intervention

Institution: University of Alberta, Canada
Grant Number: CA79460
Title: Exercise Effects on Quality of Life in Cancer Patients
QOL Intervention: Personalized exercise program to improve physicalhealth and QOL among cancer patients receiving psychosocial counseling
QOL Instruments: FACT (including FS), SWLS, CES-D, TPB Measure, GLTEQ-LSI
Principal Investigator: Kerry Courneya, PhD, (780) 492-1031, kerry.courneya@ualberta.ca

Institution: Brooklyn College, New York
Grant Number: CA68354
Title: Adjustments to Prostate Cancer
QOL Intervention: Facilitated psychoeducational support groups to enhanceQOL and adjustment
QOL Instruments: SF-36, CES-D, STAI, POMS-SF, Neugarten’s Measure of Life Satisfaction in the Elderly,DAS, IES, Mishel Uncertainty in Illness Scale, PTGI, UCLA Social Support Scale,Ingram’s Unsupportive Social Interaction Inventory, Lepore’s Social ConflictScale, LIES, Krantz Health Opinion Survey, Litwin’s Measure of Cancer-RelatedProblems
Principal Investigator:
Stephen Lepore, PhD, (718) 951-5012, slepore@brooklyn.cuny.edu

Institution: University of California Los Angeles
Grant Number: CA63028
Title: Breast Cancer-Preparing for Survivorship
QOL Intervention: Psychoeducational preparatory interventions tofacilitate transition from active treatment to survivorship
QOL Instruments: IES-R, PTGI, PANAS, MHI-17, MOS-SF-36, RAND MentalHealth Index, Ladder of Life Scale, CARES, SAQ, Expectations Scale, COPE, EAC,BCPT Symptom Checklist, KPS
Principal Investigator: Patricia Ganz, MD, (310) 206-1404 or (310)825-3181, Pganz@ucla.edu

Institution: Carnegie Mellon University
Grant Number: CA64711
Title: Adjustment to Breast Cancer Among Young Women
QOL Intervention: Psychoeducational counseling sessions vs low-fatdietary program to enhance QOL among younger women with breast cancer
QOL Instruments: MOS-SF-36, Kansas Inventory of Parental Perceptions,BSI, ABS, IES, DAS, PAIS, FSS, modified Dietary Satisfaction Scale from MDRD,LOT-R, BIS, ISEL, Lubben Social Network Scale, MBSS, COPE, IES, Timko andJanoff-Bulman Illness-Related Expectancies, MUIS-S, Personal AttributesQuestionnaire, Duke Severity of Illness Checklist, body-image combined index
Principal Investigator: Michael Scheier, PhD, (412) 268-3791, Fax (412)268-7810, scheier@cmu.edu

Institution: University of South Florida
Grant Number: CA77307
Title: A Caregiver Intervention to Improve Hospice Outcomes
QOL Intervention: Intervention based on COPE (Creativity, Optimism,Planning, Expert Information) method, friendly visits
QOL Instruments: Caregiver Quality of Life-Cancer, MOS-SF-36, MasteryScale, HQLI, COPE, MSAS, pain NRS, CAS, DGRIS, DGRRS, Global Improvement Scale,ADL, KPS, SPMSQ
Principal Investigator: Susan McMillan, RN, PhD, (813) 974-9188, smcmilla@hsc.usf.edu

Institution: Stanford University
Grant Number: MH/CA47226-11
Title: Group Therapy for PTSD in Metastatic Breast Cancer
QOL Intervention: Supportive/expressive group therapy plus education
QOL Instruments: CAPS, PCL-C, CES-D, STAI (state version), POMS-SF, SF-12Health Survey (developed from MOS-SF-36), PTGI, PSOM, SSESSI, IIYL,investigator-developed measure for pain, CDIS, SIE, ZTPI, SCS, YSSI, LSC-R,SASRQ, PDEQ, Nightcap Questionnaire and Ambulatory Device,investigator-developed psychotherapy process measure of Yalom existentialconcerns
Principal Investigator:
David Spiegel, MD, (650) 723-6421, dspiegel@stanford.edu,website:
http://pstlab.stanford.edu/

Institution: University of Washington
Grant Number: CA78424
Title: Helping the Mother with Breast Cancer Support Her Child
QOL Intervention: "Enhancing Connections Program," amulticomponent educational counseling intervention for mothers and schoolchildren during mother’s early-stage breast cancer
QOL Instruments: CES-D, STAI, FPRQ, Relatedness scale, KIDCOPE, RCMAS-WhatI Think and Feel, CDI, AMMI (including Child’s Cancer Worries Scale andDisenfranchised Grief Scale), CASE-EC, DAS
Principal Investigator: Frances Lewis, RN, MN, PhD, (206) 685-0808, fmlewis@u.washington.edu

Behavioral/Lifestyle Intervention

Institution: Boston University
Grant Number: CA78801
Title: Exercie Effects-Mental and Physical Health in Breast Cancer
QOL Intervention: Exercise intervention to promote exercise adherence
QOL Instruments: POMS, CES-D, IES, FACT-B, LOT, ISEL, SSEB, COPE, SEEB
Principal Investigator: Frank Perna, EdD, PhD, (617) 414-2030, fperna@bu.edu

Institution: University of California San Francisco
Grant Number: CA64734
Title: Self Care Intervention to Control Cancer Pain
QOL Intervention: PRO-SELF: PAIN CONTROL nurse-administered interventionwith "academic detailing" and nurse coaching given to patient orpatient-caregiver dyads
QOL Instruments: PES, MOS-SF-36, MQOLS-CA2, POMS, UCSF Pain ServicePatient Questionnaire, KPS
Principal Investigator: Christine Miaskowski, RN, PhD, FAAN, (415) 476-9407, chris.miaskowski@nursing.ucsf.edu

Institution: Fox Chase Cancer Center
Grant Number: NR/CA04573
Title: Energy Conservation and Cancer Treatment Related Fatigue
QOL Intervention: Telephone-based energy conservation/activity management(ECAM)
QOL Instruments: PRQ85, PSQI, General Fatigue Scale, POMS, ValuedActivities List, POMS, SEC
Principal Investigator: Andrea Barsevick, DNSc, RN, AOCN, (215) 728-3578,am_barsevick@fccc.edu

Institution: University of Miami, Coral Gables
Grant Number: CA64710
Title: Facilitating Positive Adaptation to Breast Cancer
QOL Intervention: Cognitive Behavioral Stress Management (CBSM) groupintervention program to induce positive responses to diagnosis of cancer
QOL Instruments: LOT-R, MBA, COPE, IES, MOCS, SPS, modified KansasInventory of Parental Perceptions, PTGI, PSOM, ABS, HRSA, HRSD (from SIGH-AD),SIP, PAIS, FSI, MFSI-SF, PSQI, positive health behavior questionnaire
Principal Investigator: Michael Antoni, PhD, (305) 284-4186, mantoni@miami.edu

Cognitive/Coping Intervention

Institution: Fox Chase Cancer Center
Grant Number: CA78084
Title: Couples Dealing with Cancer Analysis and Intervention
QOL Intervention: Communication and coping skills intervention focusingon teaching good communication/coping skills for married couples
QOL Instruments: CARES, Cancer Support Inventory (CSI), COPE (situationalformat), satisfaction with support received, MHI-18-SF, HSCL-25, IES, DAS,Current Mood VAS, MICS, Couples Interaction Coding System, questionnaire oncancer- and noncancer-related problems, KPS
Principal Investigator: Sharon Manne, PhD, (215) 728-5523, SL_Manne@fccc.edu

Institution: Fox Chase Cancer Center
Grant Number: CA85566
Title: Psychological Intervention for Ovarian Cancer Patients
QOL Intervention: Coping and communication/venting psychologicalinterventions
QOL Instruments: MHI-18, BDI, CARES, IES, DAS, Sexual AdjustmentInventory, COPE, PTGI, Protective Buffering/Sharing Concerns Measure, CancerSupport Inventory (CSI, with Social Constraint Scale items included),satisfaction with support received, SICPA, Thompson et al Perceived ControlScale, Rosenberg Self-Esteem Scale, WAI, Expectancy Rating Form, KPS, Search forMeaning
Principal Investigator: Sharon Manne, PhD, (215) 728-5523, SL_Manne@fccc.edu

Institution: University of North Carolina at Chapel Hill
Grant Number: CA78955
Title: Managing Uncertainty in Older Breast Cancer Survivors
QOL Intervention: Survivor Uncertainty Management Intervention (S-UMI), anursing intervention teaching cognitive coping strategies to manage anxiety fromuncertainty about cancer recurrence, and providing self-care methods to manageuncertainty
QOL Instruments: Social Support Questionnaire, MUIS-S, Quality ofLife-Breast Cancer Survivors, POMS-SF, Self Control Schedule, Inventory ofTroublesome Thoughts in Response to the Possibility of Recurrence (modified fromthe Negative Thoughts Inventory), CSQ, GTUS, MMSE, Survivor Knowledge Scale andPatient/Provider Communication Scale (investigator-developed), Symptom IntensityScale-Breast Cancer Survivors (modified Symptom Distress Scale, a subscale ofthe SOG QOL Questionnaire)
Principal Investigator: Merle Mishel, PhD, (919) 966-5294 or (919)966-6610 (research office), mishel@ unc.edu

Institution: North Dakota State University
Grant Number: CA77756
Title: Telephone Therapies and Coping With Breast Cancer
QOL Intervention: Emotional expression phone therapy and cancer educationphone therapy
QOL Instruments: FACT-B, POMS, Coping Response Indices, RIES, CancerBehavior Inventory, MBSS, investigator-created instruments for measuringsocial/informational support and perceived control over own stress and dailymoods/emotions/feelings
Principal Investigator: Kevin McCaul, PhD, (701) 231-7072, Kevin.McCaul@ndsu.nodak.edu

Institution: University of Vermont
Grant Number: CA67936
Title: Comparison of Psychosocial Intervention in Breast Cancer
QOL Intervention: Coping skills intervention and social supportintervention
QOL Instruments: CARES, SCL-90R, GAIS, IES, LOT, MBSS, Coping StrategiesInventory (CSI), MDSS
Principal Investigator: Bruce Compas, PhD, (802) 656-3459, Bruce.Compas@uvm.edu

Support Groups

Institution: Carnegie-Mellon University
Grant Number: CA61303
Title: Adjustment to Breast Cancer
QOL Intervention: Informational support and peer discussion (individuallyand combined)
QOL Instruments: MOS-SF-36, PANAS, PAIS, DAS (short-form), RosenbergSelf-Esteem Scale,
MUIS-S, LOT, CARES, CES-D
Principal Investigator: Vicki Helgeson, PhD, (412) 268-2624, vh2e@andrew.cmu.edu

Institution: Fred Hutchinson Cancer Center
Grant Number: CA63030
Title: Enhancing Recovery from Blood Marrow Transplantation
QOL Intervention: Facilitator-led workshops and psychoeducational andcoping skills telephone counseling to reduce impact on patients and families offunctional, psychological, and social limits during recovery. Based oninvestigator-developed "Active Coping" module and othertranstheoretical and self-efficacy models of behavior change
QOL Instruments: RS, Ambulation Subscale from SIP, MOS-SF-36, MMQ, NBRS,FRI, FWF, DAS, CIS, BMTD, SCLDA (Depression and Anxiety Scale of SCL-90-R), SFQ,COPE, IES, PEPI, MDAS, DRS
Principal Investigator: Karen Syrjala, PhD, (206) 667-4579, ksyrjala@fhcrc.org

Institution: University of Texas M. D. Anderson Cancer Center
Grant Number: MH/CA59432
Title: Presurgical Stress Reduction Mental Health and Cancer
QOL Intervention: Presurgical stress management group vs attentioncontrol group vs usual care control group. Evaluates dimensions of response tosurgery and recovery
QOL Instruments: SRE, SCL-90R, POMS, COPE, LOT-R, SSS, DAS, FACT-P, SF-MPQ-SF,HRSD, HRSA, Surgery Concerns Survey, Satisfaction and Cancer Knowledge Test,relaxation skills self-monitoring form
Principal Investigator: Lorenzo Cohen, PhD, (713) 792-0919, lcohen@mail.mdanderson.org

Pharmacologic and Dietary Interventions

Institution: University of California San Diego
Grant Number: CA69375
Title:
Randomized Controlled Trial (RCT) of Plant-Based Diet in BreastCancer Recurrence
QOL Intervention: Dietary
QOL Instruments: Thoughts and Feelings Questionnaire, WHEL LifestyleQuestionnaire (including WHEL Supplement Usage), Personal Habits, Health StatusQuestionnaire, Arizona Food Frequency Questionnaire,
24-hour dietary recalls
Principal Investigator: John Pierce, PhD, (858) 822-2380, jppierce@ucsd.edu

Institution: Oregon Health & Science University
Grant Number: NR/CA05084
Title: Breast Cancer Survivors: Exercise and Raloxifene
QOL Intervention: Exercise and raloxifene effects on QOL and osteoporosisin postchemotherapy breast cancer patients
QOL Instruments: PANAS, MOS-SF-36, SEC, Schwartz Cancer Fatigue Scale,FFQ, Cognitive Domain
Principal Investigator: Anna Schwartz, PhD, (503) 494-8167, schwarta@ohsu.edu

References:

1. Meyer TJ, Mark MM: Effects of psychosocial interventions with adult cancerpatients: A meta-analysis of randomized experiments. Health Psychol 14:101-108,1995.

2. Devine EC, Westlake SK: The effects of psychoeducational care provided toadults with cancer: Meta-analysis of 116 studies. Oncol Nurs Forum 22:1369-1381,1995.

3. Cella DF: Quality of life outcomes: Measurement and validation. Oncology10(suppl):233-246, 1995.

4. Osoba D, Rodrigues G, Myles J, et al: Interpreting the significance ofchanges in health-related quality-of-life scores. J Clin Oncol 16:139-144, 1998.

5. Kornblith AM, Holland JC: Handbook of Measures of Psychological, Socialand Physical Function in Cancer, Vol 1: Quality of Life. New York, MemorialSloan-Kettering Cancer Center, 1994.

Key to Acronyms Used in QOL Instruments and Measures

ABS Affects Balance Scale
ADL see Katz ADL
AMMI About My Mother’s Illness
BDI Beck Depression Inventory
BIS Body Investment Scale
BMTD Bone and Marrow Transplantation Events
CAPS Clinician-Administered PTSD Scale
CARES Cancer Rehabilitation Evaluation System
CAS Constipation Assessment Scale
CASE-EC Cancer Self-Efficacy
CDI Child Depression Inventory
CDIS Cancer Diagnostic Interview Scale
CES-D Center for Epidemiologic Studies-Depression Scale
CIS Caregiver Impact Scale
COPE Coping Orientations to Problems Experienced
CSI Cancer Support Inventory (in grants CA78084 and CA85566)
CSI Coping Strategies Inventory (in grant CA67936)
CSQ Cognitive Coping Strategies Questionnaire
DAS Spanier’s Dyadic Adjustment Scale
DGRIS Dyspnea Graphic Rating Intensity Scale
DGRRS Dyspnea Graphic Rating Response Scale
DRS Delirium Rating Scale
EAC Emotional Approach Coping
FACT-B Functional Assessment of Cancer Therapy-Breast
FACT-P Functional Assessment of Cancer Therapy-Prostate
FFQ Women’s Health Initiative Food Frequency Questionnaire
FPRQ Family-Peer Relationship Questionnaire
FRI Family Relations Index
FSI Fatigue Symptom Inventory
FSS Family Stress Scale
FWF Family/Work Form
GAIS Global Adjustment to Illness Scale
GLTEQ-LSI Godin Leisure Time Exercise Questionnaire Leisure Score Index
GTUS Growth Through Uncertainty Scale
HQLI Hospice Quality of Life Index
HSCL-25 Hopkins Symptom Checklist-25
HRSD/HRSA Hamilton Rating Scale for Depression/Anxiety
IES Impact of Events Scale
IES-R, RIES Revised Impact of Events Scale
IIYL Impact of Illness on Your Life questionnaire
ISEL Interpersonal Support Evaluation List
Katz ADL Katz Activities of Daily Living Scale
KPS Karnofsky Performance Status Scale
LIES Lepore’s Inhibition of Emotions Scale
LSC-R Life Stressor Checklist-Revised
LOT Life Orientation Test
LOT-R Revised Life Orientation Test
MBA Measure of Body Apperception
MBSS Miller Behavioral Style Scale
MDAS Memorial Delirium Assessment Scale
MDRD Modification of Diet in Renal Disease Study Dietary Satisfaction Scale
MDSS Multi-Dimensional Support Scale
MFSI-SF Multidimensional Fatigue Symptom Inventory—Short Form

MHI Mental Health Index/Inventory from MOS
MICS Marital Interaction Coding System
MMQ Modified Memory Questionnaire
MMSE Folstein Mini Mental Status Exam
MOCS Measure of Current Status
MOS-SF-36 Medical Outcomes Survey—Short Form
MQOLS-CA2 Multidimensional Quality of Life Scale—Cancer
MSAS Memorial Symptom Assessment Scale
MUIS-S Mishel Uncertainty in Illness Scale—Survivor Version
NBRS Neurobehavioral Rating Scale
NRS Numeric Rating Scale (not a specific instrument)
PAIS Psychosocial Adjustment to Illness Scale
PANAS Positive and Negative Affect Schedule
PCL-C PTSD Checklist—Civilian Version
PDEQ Peritraumatic Dissociative Experiences Questionnaire
PEPI Postmenopausal Estrogen Progesterone Intervention Scale
PES Pain Experience Scale
PRQ85 Personal Resources Questionnaire
POMS-SF Profile of Mood States—Short Form
PSOM Positive States of Mind
PSQI Pittsburgh Sleep Quality Index
PTGI Post-Traumatic Growth Inventory
RAND-36 RAND Mental Health Index 36-Item Health Survey
RCMAS Retrospective Case-Mix Analysis System—What I Think and Feel
RIES see IES-R
RS Rehabilitation Scale
SAQ Sexual Activity Questionnaire
SASRQ Stanford Acute Stress Reaction Questionnaire
SCL-90R Symptom Checklist 90 Revised
SCLDA Depression and Anxiety Scale of SCL-90R
SCS Social Constraints Scale
SEC Side Effect Checklist
SEEB Self-Efficacy Scale for Exercie Behavior
SF-12 Health Survey developed from MOS-SF-36
SF-MPQ Short Form McGill Pain Questionnaire
SFQ Sexual Functioning Questionnaire/Scale
SICPA Stanford Inventory of Cancer Patient Adjustment
SIE Stressful Illness Experience
SIGH-AD Structured Clinical Interview Guide for Hamilton Anxiety and Depression Rating Scales
SIP Sickness Impact Profile
SPMSQ Short Portable Mental Status Questionnaire
SPS Social Provisions Scale
SRE Schedule of Recent Experiences
SSEB Social Support Scale of Exercise Behavior
SSESSI Stanford Self-Efficacy Scale for Serious Illness
SSS MOS Social Support Survey
STAI Spielberger State/Trait Anxiety Inventory
SWLS Satisfaction With Life Scale
TPB Theory of Planned Behavior measure
VAS Visual Analog Scale
WAI Working Alliance Inventory
WHEL Women’s Healthy Eating and Living
YSSI Yale Social Support Index
ZTPI Zimbardo Time Perspective Inventory