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 list was to increase the clinician’s awareness of, and referral of potentially eligible patients to ongoing trials in this area.
In part II, we provide a list of investigator-initiated (R01 type) grants that address interventions to improve HRQOL or health outcomes among patients in active treatment or post-treatment. Because all of these studies are being conducted at specific sites or with previously identified samples, none are "open to accrual" from the general oncology population. (In rare cases, a clinician may be able to enroll a patient because the study’s principal investigator is affiliated with or using patients from their cancer center or local region.)
Our intent in identifying these studies is fourfold. First, as a group they illustrate the direction being taken in HRQOL research that is coming out of the independent investigator community. In contrast to the cancer cooperative groups, the HRQOL focused studies from the investigator-driven community are shifting away from descriptive research. Increasingly, they are proposing (and being funded) to develop and test the efficacy of interventions (both medical and psychosocial/behavioral) to improve HRQOL. Over 50% of the HRQOL-related R01 studies supported by the National Cancer Institute (NCI) now include an intervention component.
Second, by providing information on the different kinds of interventions in development, clinicians and researchers may be stimulated to consider which of these interventions, if successful, might be suitable for phase III testing. One of the major barriers to behavioral/HRQOL research in the oncology setting has been the failure to take successful intervention projects beyond the phase II pilot trial. For example, two meta-analyses have shown that a number of behavioral interventions can improve psychosocial, and in some cases medical, outcomes for treated patients,[1-2] yet phase III studies are not being conducted.
Third, by providing information on these studies, we hope to encourage collaborative research among investigators with common research goals. While fewer subjects are generally needed to evaluate HRQOL-related outcomes than drug treatment outcomes, it is still rare for a single institution alone to be able to 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 for appropriate assessment tools. In addition, this information may facilitate a comparison of data already collected with that gathered using the same or similar instruments being used to evaluate different treatments, populations, or follow-up periods.
Fortunately, access to appropriate measurement tools is no longer a significant barrier to advancing HRQOL research. The past decade has seen the growth of an increasing number of well-developed and reliable instruments that permit us to quantify the impact of cancer on patients’ quality, not merely length, of survival.[3-5] It is no longer necessary, or even desirable, for researchers to design assessment measures de novo for a given project. With broader use of common metrics, it will be possible to accurately evaluate the burden of cancer on the larger survivor population as well as our efforts to reduce this burden through clinical research, cancer practice, and health-care policy change.
A key to the many acronyms used in the following listings is provided at the end of this article.
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 physical health 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, email@example.com
Institution: Brooklyn College, New York
Grant Number: CA68354
Title: Adjustments to Prostate Cancer
QOL Intervention: Facilitated psychoeducational support groups to enhance QOL 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 Conflict Scale, LIES, Krantz Health Opinion Survey, Litwin’s Measure of Cancer-Related Problems
Principal Investigator: Stephen Lepore, PhD, (718) 951-5012, firstname.lastname@example.org
Institution: University of California Los Angeles
Grant Number: CA63028
Title: Breast Cancer-Preparing for Survivorship
QOL Intervention: Psychoeducational preparatory interventions to facilitate transition from active treatment to survivorship
QOL Instruments: IES-R, PTGI, PANAS, MHI-17, MOS-SF-36, RAND Mental Health 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-fat dietary 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 and Janoff-Bulman Illness-Related Expectancies, MUIS-S, Personal Attributes Questionnaire, Duke Severity of Illness Checklist, body-image combined index
Principal Investigator: Michael Scheier, PhD, (412) 268-3791, Fax (412) 268-7810, email@example.com
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, Mastery Scale, HQLI, COPE, MSAS, pain NRS, CAS, DGRIS, DGRRS, Global Improvement Scale, ADL, KPS, SPMSQ
Principal Investigator: Susan McMillan, RN, PhD, (813) 974-9188, firstname.lastname@example.org
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-12 Health 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 existential concerns
Principal Investigator: David Spiegel, MD, (650) 723-6421, email@example.com, website:
Institution: University of Washington
Grant Number: CA78424
Title: Helping the Mother with Breast Cancer Support Her Child
QOL Intervention: "Enhancing Connections Program," a multicomponent educational counseling intervention for mothers and school children during mother’s early-stage breast cancer
QOL Instruments: CES-D, STAI, FPRQ, Relatedness scale, KIDCOPE, RCMAS-What I Think and Feel, CDI, AMMI (including Child’s Cancer Worries Scale and Disenfranchised Grief Scale), CASE-EC, DAS
Principal Investigator: Frances Lewis, RN, MN, PhD, (206) 685-0808, firstname.lastname@example.org