Use of complementary/alternative

medicine in breast cancer patients

Introduction

Purpose/Goal
The purpose of this study is to determine the patterns of use, costs,
and factors associated with use of complementary/ alternative
therapies by women living in the Wabash Valley area who have been
diagnosed with breast cancer for at least 6 months. This study will
be a second site for a larger study being conducted through the Lee
Moffitt Cancer and Research Institute in Tampa Florida.

Specific Aims

1. To identify patterns of use of complementary/alternative

therapies in a sample of persons who have been diagnosed
with breast cancer.
2. To identify costs related to use of complementary/alternative
therapies.
3. To identify factors associated with use of
complementary/alternative therapies.
4. To identify complementary/alternative therapies that women
diagnosed with breast cancer find to be helpful.

Relevance Statement
Practitioners of conventional medicine have justifiably criticized
most complementary/alternative medical (CAM) therapies for the
relative lack of peer reviewed scientifically conducted analysis.
Nevertheless, use of these therapies has increased so dramatically
in the US and Europe, that it is unwise for medical science to
continue to ignore this potentially harmful situation (Cassileth &
Chapman, 1996a; Downer, et al., 1994). Documented use of
complementary/alternative therapies in both oncology and non-
oncology patients is estimated to be as high as 45% (Cassileth &
Chapman, 1996a; Downer, et al., 1994; Eisenberg, et al., 1993;
Munstedt, Kirsch, Milch, Sachsse & Vahrson, 1996).

Although several studies on use of complementary therapies in

cancer patients have been carried out in North America and
Northern European countries, there is a shortage of reliable
information about the types of therapies being used, the cost of
these therapies, how patients are referred to these therapies, and
the reasons for choosing to use complementary therapies. Pervious
studies indicate that users tend to be younger, of higher social class
and are more likely to be women (Bennett & Lengacher, 1999;
Downer, et al., 1994). Therefore, an in-depth study of the patterns
of use of complementary therapies in a selected group of women
with breast cancer could answer many of these questions.

First this study has relevance to the treatment of breast cancer

because it is critical to identify current patterns of use of CAM, to
provide information needed to help patients avoid possible harmful
side effects and medication interactions. Once patterns of use are
identified, the scientific community can examine specific CAM
therapies for efficacy, which could impact survival and quality of life.

Second this study has relevance in that although increases in use of

individual CAM have been cited in the literature, patterns of use in
breast cancer patients has not been adequately documented.
Criticisms are related to lack of or improper evaluation of CAM, the
practice of some CAM providers discouraging or preventing patients
from seeking appropriate medical treatment, potentially harmful
side effects from some CAM, and some providers preying on
desperate patients.

Third, this study has relevance in that it will show the impact of
increasing out of pocket expenses for CAM treatments and
insurance coverage costs. Some of the CAM is relatively cost
effective, i.e, relaxation guided imagery tapes, and others may be
quite costly.

Fourth this study has relevance in that it will help identify reasons
women with breast cancer seek out complementary and alternative
therapies, and their relative satisfaction with the specific CAM
therapies they have tried. Information from this study will assist
traditional medicine to learn more about effective CAM and to offer
more integrative services. Results of this study will provide data for
further testing of specific therapies, which will give new empirical
evidence on the safety and efficacy of these therapies.

Documenting the use, reasons for use, patient reports of benefits

gained, and costs of CAM in a group of women with breast cancer
can serve as a guide for future studies. Documenting commonly
used therapies that are not found to be helpful for women with
breast cancer will guide us in patient teaching and help us ask
appropriate questions during the admission examination. On the
other hand, cost-effective and non-harmful CAM therapies may well
prove to have a role in the medical treatment plan by relieving
psychological and physical symptoms of cancer, controlling side
effects from conventional therapy, and helping patients gain a sense
of control while living with breast cancer.
Review of Literature

Background
Alternative/complementary therapies have recently become a
multimillion business in the US and several European nations, with
many patients paying more in out-of-pocket costs for these
treatments than they do for standard medical care. The use of these
therapies generate questions related to inadequate evaluation of the
costs, risks, and benefits of specific therapies, along with problems
related to possible suppression of effective conventional therapies
and motivation for profits received from desperate persons seeking
self-healing (Brigden, 1995; Guzley, 1992; Fletcher, 1992). Given
the ever increasing numbers of herbs, supplements and non-
conventional substances that are on the market, knowing which
ones our patients are likely to be using and the probable side effects
associated with these “popular” supplements will greatly assist
health care providers to provide appropriate patient education on
this topic, as well as altering us to watch for known side effects and
medication interactions (Montbriand, 1999; Zaloznik, 1994).

Trends in Use of Alternative Medicine

Use of alternative therapies has increased in the general population
from 33.8% in 1990 to 42.1% in 1997 (Eisenberg, et al., 1998).
Complementary/alternative medicine (CAM) has been reported to be
used by 25%-50% of the general population as identified in
industrialized nations (Cassileth & Chapman, 1996a; Eisenberg, et
al., 1993; Lerner & Kennedy, 1992). The reasons for increasing use
are very complex, but increased consumer demand for more choice
and control, and an increased growth in availability and variety of
types of therapies are identified to be factors. In addition, increased
use could be reflected in an increasing number of insurers and
managed care organizations which offer programs and benefits
(Blais, Maiga & Aboubacar, 1997; Eisenberg, et al., 1998). Use can
be related to social and cultural reasons, however lack of hope for a
medical cure is frequently a primary motivation (Downer, et al.,
1994). In two studies of “unconventional medicine” in the United
States, most persons reported using non-conventional treatment for
non-life threatening chronic conditions, for which there may be no
effective medical treatment (Cassileth & Chapman, 1996a;
Eisenberg, et al., 1993). The cost of this use of CAM is significant.
From the first study completed in 1993 to the second in 1997, there
was a 45.2% increase in estimated expenditures for alternative
medicine professional services, with an estimate of $12.2 billion
paid out of pocket, which was estimated to exceed 1997 out-of
pocket expenditures for all hospitalizations. However, many of the
studies cited above were not aimed at, nor limited to, persons with
cancer (Eisenberg, et al., 1998).
Trends in Use with Oncology Patients
A variety of methods have been used in the past in an attempt to
determine complementary/alternative therapy use among persons
with cancer. Early studies, while providing some information on the
use of alternative therapy, frequently were biased by focusing on
what the researchers termed “unorthodox, unconventional or
questionable” cancer cures, and did not adequately document
participants’ use of complementary therapies to improve well-being
and quality of life. Many of these early studies considered a therapy
“orthodox” if it was used to improve mental well-being, decrease
pain, or improve quality of life, but treated the same therapy as
“unorthodox” if the intent was also to improve the physical well-
being of the person with cancer (Cassileth, Lusk, Strouse &
Bodenheimer, 1984). In a study using a self-developed interview to
determine the use of “unorthodox” cancer therapies among US
persons with cancer 43% of the participants used conventional
therapy alone, 8% used unorthodox therapy alone, and 49% used a
combination of conventional therapy and unorthodox treatment. The
most popular unorthodox treatments were metabolic therapy 42%,
diet therapy 35%, megavitamin therapy 24%, imagery 24%,
spiritual/faith healing 19%, and immune therapy (injecting various
substances to boost immune function) 15%. Most persons were
using more than one type of unorthodox therapy, combined with
conventional medical treatment (Cassileth, et al., 1984).

The early studies in this area reported that use of alternative

therapies among cancer patients range from 9%-50%. However
there is indication that these estimates may be low, because
patients are reluctant to report use of unconventional therapies.
Unconventional alternative therapy methods appeal to patients with
advanced stage cancer primarily to improve their quality and length
of life (Caudell, 1996; Mahon, Cella & Donovan, 1990). There is also
evidence to suggest that oncologists may have less negative
attitudes towards use of complementary therapies today, than
previously (Andritzky, 1995).

In a review of 21 studies, the range of use in cancer patients was

from 7% to 64%. Major problems identified were inconsistent
definitions of CAM, with some studies counting conventional
psychological methods such as group therapy as CAM, and few
studies differentiated between therapies used in an adjunctive mode
and those applied towards cure, exclusive of mainstream treatment.
Future research needs to center itself on clarifying distinctions
between potential harmful alternative cures and potentially
beneficial therapies that can be used to as adjuncts to cancer
treatment, thus relieving symptoms of cancer or control treatment
side effects. In addition, more standardization of questions is
needed, to generate more comparable data. In an attempt to
increase standardization, items on the instrument used in this study
(CTRS II) were taken from the list of complementary/alternative
treatments published by Office of Alternative Medicine, National
Institute of Health (Bennett & Lengacher, 1998; Bennett &
Lengacher, 1999).

Use of CAM in Breast Cancer

An early study of unorthodox treatments in cancer medicine
identified that 32% of the breast cancer patients surveyed used
conventional along with unorthodox therapies. Persons with breast
cancer were the highest users of combined CAM and orthodox
treatments in the malignant diseases assessed. Breast cancer was
second compared to genitourinary in using unorthodox treatment
alone: 23% compared to 30%. In this study, the largest percentage
of users of both conventional and unorthodox treatments was
women, 68% compared to men (32%) (Cassileth, et al., 1984).

One of the most recent studies was completed in Europe, in which

use was examined while attending conventional treatment (Crocerri,
et al., 1998). Results from 242 responders showed that 16% were
using complementary therapies (CT) one year after diagnosis,
compared to 8.7% before diagnosis with breast cancer. The main
reason for using CT was physical distress. The most common CAM
was homeopathy, manual healing, herbalism and acupuncture.
However, rates of use of specific CAM therapies, their usefulness
and their cost in the treatment of women with breast cancer has not
been well documented.

Theoretical Framework
The theory of reasoned action (Ajzen, 1980) provides a conceptual
framework within which to consider the use of complementary
therapies by persons with cancer. The theory of reasoned action
examines the relationships among subject attitudes, subjective
norms, intentions and behaviors. According to the theory, behavior
is the result of a specific behavioral intention. In this study, a
participant's positive response toward a specific complementary
therapy will be regarded as a behavioral intention. A behavioral
intention is determined by the attitude toward the behavior and the
subjective norm regarding that behavior. A participant's intention to
use a complementary therapy is a function of attitude, which can be
positive or negative. Attitudes reflect the participant's beliefs about
the consequences of participating in the behavior, and evaluations
of these consequences. For example, if a participant believes that a
specific complementary therapy will help in coping with the disease,
the attitude towards that therapy is positive. In addition to
attitudes, subjective norms also play a part in the decision making
process. Subjective norms are perceptions of what important
others are perceived to think about a certain subject. For example,
if a participant believes that significant others approve of the choice
to participate in a particular complementary therapy, there will be a
stronger intention to participate in the therapy. Both attitudes and
subjective norms play a part in the development of a behavioral
intention. In this study, the Complementary Therapy Rating Scale
II (CTRSII) will be used to measure the behavioral intentions of
rural persons with cancer towards the use of various complementary
therapies.

Methods

This study will use a descriptive, cross-sectional survey design to

determine patterns of use of complementary therapies among
women with breast cancer. The CTRS II will be distributed to
women with breast cancer using a variety of methods, including
face to face interview format, phone interview format, and mail
surveys for those whom it is not possible to reach using the first
two formats. Research assistants for data collection will be recruited
from Indiana State University nursing students, as well as oncology
staff nurses serving in various hospitals and clinics. The primary
researcher will oversee the research process, data coding, data
base development, conduct data analysis, and be responsible for
the final version of the study report. This will be facilitated by
Indiana State University releasing the PI for 10% time as in-kind
support. The part-time graduate assistant hired with grant funding
will coordinate and facilitate institutional review for the various
institutions, data collection, data coding and data entry into the
SPSS database.

Sample Description and Inclusion Criteria

A sample of 100 women diagnosed with breast cancer will be
recruited from the Inclusion criteria include a clinical diagnosis of
breast cancer, all stages of breast cancer and all ages will be
included. Participants must have been diagnosed for at least 6
months for inclusion into this study. Participants must be able to
speak and understand English well enough to answer the survey
questions. Survey data obtained will be linked to the
Comprehensive Breast Cancer Data Base.

Procedures for Subject Recruitment, Timeline, and Informed

Consent
In the first 3 months of this study, local physicians, nursing staff on
oncology units and oncologists will be contacted and asked to assist
in this study by allowing our research team to either distribute
surveys through their offices, or by posting information concerning
our study where appropriate subjects can learn of the study and call
for more information. Community support groups for persons with
cancer will also be contacted, and asked to assist the researchers in
locating appropriate subjects for this study. Snowball subject
recruitment methods will also be utilized, where subjects with
breast cancer will be asked to pass along study contact information
to other persons with breast cancer whom they believe would like to
participate. Research subjects will receive a gift basket of self-care
items in appreciation of their time and effort spent on this project.
Community data collectors not employed by ISU (staff nurses
and/or nursing students), will be paid $10 per complete survey form
collected, to compensate them for the time involved in subject
recruitment and interviewing. Data collection is estimated to take a
total of 9 months. Data analysis and the study report will be written
in the final 3 months of this 1 year project. A project update will be
mailed to the funding agency 6 months into the study. Informed
consent will be obtained from all participants, Data will be treated
as confidential and only reporting of group data will occur. Each
person’s name will be kept confidential, and surveys will be coded to
allow survey results to be linked to the Comprehensive Breast
Program’s Data Base.

Instrument/Study Measures
The survey instrument to be used in this study is an enhanced
version of the Complementary Therapy Rating Scale, which was
used in the earlier investigations (Bennett & Lengacher, 1998;
Bennett & Lengacher, 1999). See appendix B for copies of articles.
Using standardized classifications of complementary therapies from
the Office of Alternative Medicine, several new categories have been
added to this instrument. Reliability data for the previously
published version of the Complementary Therapy Rating Scale was
.86 using odd-even split half reliability and .77 using coefficient
alpha. The scale has been revised in an effort to obtain more
complete data for this study. Additional questions concerning
reasons for using CAM, cost of use, and if the patient had informed
their physician about their use of CAM have been included. In
addition, questions related to patient recommendations for CAM
use, how helpful specific CAM therapies are, who provides the CAM
treatment and satisfaction with both conventional and CAM
therapies have been added.

Preliminary data and plan for dissemination of results of this

study.
The earlier version of the CTRS was developed and tested in a
sample of rural Midwestern cancer patients. The CTRS has
subsequently been published (Bennett & Lengacher, 1998), as have
the preliminary results obtained with it (Bennett & Lengacher,
1999). However, the original CTRS did not elicit data on use of
specific herbal treatments or other alternative therapy options.
These treatments tend to be some of the most dangerous and
further information is needed on the use of these items. In addition,
this study will elicit patient evaluation of specific therapy usefulness,
cost of therapy, physician disclosure, and reasons for use of these
therapies. The revised instrument adapted for this study will allow
for collection of this important data. Results of this study will be
disseminated as were the results of our earlier studies: on the
internet via the primary researcher’s webpage, through research
and community presentations, and will be submitted for publication
in an appropriate research journal. The data will also be added to
data in the larger study being conducted at the Lee Moffitt Cancer
and Research Institute in Tampa Florida.

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