Transcript NCRI 2010 Patient reasons for declining to participate - SHORE-C

What reasons do patients give for declining
or participating in early phase cancer trials?
Susan Catt1, Carolyn Langridge1, Valerie Jenkins1, Denis Talbot2, Lesley Fallowfield1
1
CRUK Psychosocial Oncology Group, Brighton & Sussex Medical School
2 University of Oxford Medical Oncology Unit
Background
Communication with patients contemplating early phase cancer trial participation can be challenging. It is an
ethical imperative that consent is given freely and that it is both informed and educated. Controversy exists as to whether or not
patients are provided with information that is comprehensive enough to permit truly informed consent1. Even if communication is
appropriate, appreciation of other factors motivating trial entry is important. We present data from a larger CRUK funded
communication study2 examining the reasons patients gave for accepting or declining Phase I/II trials.
Method
Following discussions with oncologists about PI/II trials patients
completed 3 questionnaires.
1) Accept – Decline Questionnaire
a 19 item study specific tool measuring:●
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hope and expectations of benefit
altruism
pressures to participate
concerns about the trial
general perceptions of trial information provided
2) General Health Questionnaire (GHQ12)
3) Life Orientation Test (LOT-R)
Sample n=49 (*=1 missing data)
Sample
Sex (M/F)
Age mean (sd)
Education* - no exams
O/A levels
University
Employed* (yes/no)
Married* (yes/no)
Cancer site - Colorectal/upper GI
Skin
Breast
Gynaecological
Other
Past trial experience (yes)
LOT-R mean (sd)
GHQ12* (above/below case threshold)
30 (61%) / 19 (39%)
58 yrs (10.59)
17 (36%)
15 (31%)
16 (33%)
16 (33%) / 32 (67%)
36 (75%) / 12 (25%)
25 (52%)
8 (16%)
6 (12%)
5 (10%)
5 (10%)
18 (37%)
15.53 (3.44)
23 (48%) / 25 (52%)
Results
● most (92%) of patients accepted trial entry
Main factors motivating trial entry
Patients nominated their main reason for accepting
trial entry these are displayed in the chart below (n=45).
● only 4 declined which is too small for statistical analysis.
The prime reason given was fear that participation
would detract from quality of life (see box below)
medica l benefit
ID 16 “Now back with my husband, moving back to
Wales to make the most of whatever time I have left.”
ID 20 “Quality of life is far more important than quantity.”
best option
assist research
● overall patients had optimistic personality traits,
though lower optimism was significantly associated
with probable psychological morbidity
Statements about trial participation
Patients’ frequency of agreement to statements on
the accept - decline measure showed that:
gives hope
ONLY option
help others
better care
nothing to lose
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90-98% agreed they had sufficient trial information
most (96%) placed their trust in the doctor treating them
three quarters expected to derive medical benefit from the trial
85% did NOT feel unable to say no to the trial
83% agreed joining the trial would give them hope
a quarter worried about being a guinea pig
few (13%) had concerns about trial burdens
can withdraw
other
0
2
4
6
8
10
frequency
Conclusions
Patients considering PI/II trials may be a self-selected group with optimistic expectations for personal
benefit helping to drive trial entry. Achieving genuinely informed consent and avoidance of therapeutic misconceptions in
such patients might be difficult. A communication skills course informed by these data has been developed (see poster
A59) .
References: 1Jenkins, V, Anderson, J, Fallowfield, L. 2010 Support Care Cancer, 18 (9):1115-21.
2Jenkins, Solis-Trapala, Langridge, Catt, Talbot, Fallowfield. 2010 Journal of Clinical Oncology (in press)
Acknowledgements: Cancer Research UK funded this work. We thank all patients who participated.