Transcript Coping with head and neck cancer: A feasibility study

How to improve informal interventions:
The impact of counselling interventions
Paul Allison
McGill University
Montreal, Canada
Quality of Life in H&N Cancer
5th International Workshop
2nd & 3rd November 2006
Acknowledgements

Financial support of the Canadian Institutes of Health
Research

Therapists: Terrye Pearlman & Carol Archer

Research Assistant: Nathalie Socard

Student: Larissa Vilela

Co-researchers: Linda Edgar, Mike Hier, Marti Black,
Eduardo Franco, Jocelyne Feine, Raghu Rajan, Belinda
Nicolau
Presentation outline





An overview of psychosocial interventions in
cancer therapy
A look at the effect of some of these
interventions
Interventions in H&N cancer
The “Nucare” psycho-educational (counselling)
program
The effect of this program


Pilot work
A on-going RCT
Systematic review of interventions
(Newell et al, 2002)


Identified 627 papers concerning
psychological intervention trials
Quality assessment reduced this to 82
trials:



34 with psychosocial outcomes
38 with side-effect outcomes
10 with survival or immunological outcomes
Systematic review of interventions
(Newell et al, 2002)

Interventions









Group/individual therapy
Therapist/non therapist
With significant other
Info’ & education
Un/structured counseling
Relaxation
Cognitive/behavioural
therapy
Hypnosis
Music
etc.

Outcomes











Anxiety
Depression
Affect
Hostility
Stress/distress
QOL/functioning
Coping/control
Social adjustment
Survival
Immune system
Symptoms
etc.
Systematic review of interventions
(Newell et al, 2002)

Concluded that:



It was very difficult to conclude anything concrete
about the effectiveness of interventions.
However, “….. Some intervention strategies
appeared to provide potential benefits. For
example, group therapy, education, structured and
unstructured counseling and cognitive behavioural
therapy offered the most promise for their
medium- and long-term benefits for many of the
psychosocial outcomes explored.”
But, “… no intervention could be recommended for
improving patients’ lengths of survival…..”
Systematic review of interventions
(Newell et al, 2002)

They also observed that:





Although many RCTs performed, the quality of
those trials/the reporting was generally poor
Most trials had small samples (?type II error)
Most trials assessed short-to-medium term
outcomes only
So their conclusions were very conservative and
aimed to promote research investigating those
types of interventions with apparent potential
They claimed this to have been “…one of the most
rigorous and extensive …” reviews on the subject
Meta-analysis of Psy’l I’ns in adult
cancer (Rehse & Pukrop, 2003)

Performed to address the questions:

Overall effect size of Psy’l I’ns on QOL
Effect sizes of different Psy’l I’ns
Effect size and duration of Psy’l I’n
Modifying effects of co-variables

……plus some methodological questions



Meta-analysis of Psy’l I’ns in adult
cancer (Rehse & Pukrop, 2003)


37 RCTs identified
Interventions categorised as:





Purely educational (16%)
Professional led support therapy (12%)
Cognitive-behavioural therapy (54%)
Psychotherapy (18%)
Duration categorised as:

< 13 weeks & > 12 weeks
Meta-analysis of Psy’l I’ns in adult
cancer (Rehse & Pukrop, 2003)

Results:


Overall effect size on QOL in adults was
0.65 (moderate)
Effect sizes were greater with
interventions lasting > 12 weeks
Systematic review of Psy’l I’ns in
advanced cancer (Uitterhoeve et al, 2004)

13 RCTs

12 used behavioural therapy









4 of these combined with support therapy
2 more combined with counselling
1 used counselling alone
4 used group format
8 used nurses or psychotherapists
8 interventions individualised
5 interventions standardised
10 used multiple sessions
4 last longer than 8 weeks
Systematic review of Psy’l I’ns in
advanced cancer (Uitterhoeve et al, 2004)


12/13 trials showed a benefit for one or
more indicators of QOL
Particular domains that improved were:



Depression
Sadness
Coping mechanisms
Cochrane review of Psy’l I’ns for
metastatic breast cancer (Edwards et al, 2006)

5 RCTs identified

Again categorised possible therapies into:
Educational
 Psychotherapy
 Cognitive-behavioural
 Group therapy


In this review:
2 cognitive behavioural therapy
 3 group support therapy

Cochrane review of Psy’l I’ns for
metastatic breast cancer (Edwards et al, 2006)


Short-term benefits for QOL outcomes
in all studies – but these benefits are
not maintained to even a few months
No effect on survival
Cochrane review of “non-invasive” I’ns
for lung cancer (Sola et al, 2006)

9 studies included:






2 nursing interventions for breathlessness
3 nursing follow-up programmes
1 nutritional intervention
1 psychotherapeutic intervention
1 exercise intervention
1 reflexology intervention
Cochrane review of “non-invasive” I’ns
for lung cancer (Sola et al, 2006)

The goal was to assess the effects of
these interventions on QOL


The nurse interventions for breathlessness
and the nursing programmes may have
beneficial effects on QOL
Psychotherapy may improve coping skills
for emotional symptoms
Intervention studies in H&N cancer
(Hammerlid et al, 1999)

Feasibility study for psychosocial intervention for
two groups:



Long-term group psychotherapy (regular psychotherapist-led
meetings over 6-month period following diagnosis) for newly
diagnosed H&N cancer patients
Short-term psycho-educational program (1 week intensive
course involving several professionals, groups, individual
sessions, sessions with partners and leisure activities) 1 year
post-treatment
Preliminary findings from both interventions suggested
improvements in various elements of QOL compared with
passive control groups
Intervention studies in H&N cancer
al, 2004)








(Katz et
Short-term psycho-educational program
Delivered by nurse preoperatively and predischarge
Pilot study
Randomised design
10 test intervention
9 standard care
3 month follow-up
Multiple outcomes
Intervention studies in H&N cancer
al, 2004)

(Katz et
Results:



Test group had knowledge change
Test group had less body image disturbance
Test group has lower anxiety
Now our work! Study aims
To assess the feasibility of providing a
psycho-educational program for patients
with H&N cancer in one of 3 formats:
1.



2.
3.
One-to-one with therapist
Small group (3/4 people) with therapist
Home alone version, without therapist
To generate preliminary outcomes data for
use in developing the protocol for a RCT of
the intervention
To compare outcomes in those receiving the
intervention with a control group receiving
nothing
Methodology – the intervention

The Nucare program


(Edgar et al, 2001)
a short-term psycho-educational coping skills
training intervention
The components of the program include:






Problem-solving techniques
Goal-setting
Cognitive reappraisal
Relaxation training
Effective use of social support
Communication strategies
Methodology – the intervention

Material



One-to-one format



2-3 one or two-hour sessions with therapist
Partner may be present
Group format




Book
Audio cassette or CD
3 or 4 people
Partners may not be present
2-3 one or two-hour sessions with therapist
Home alone

Subject given material and has 30 min. phone or face-to-face
conversation with therapist on use of material
Methodology – study subjects

Inclusion/exclusion criteria:






Any H&N malignancy
No previous cancer
French/English language skills
Recruited at anytime between diagnosis and
up to 36 months later
Controls matched to cases by stage
Recruitment site:

One Montreal hospital H&N cancer centre
Methodology - evaluation

Process evaluation




Proportions participating, dropping out etc.
Choices of delivery method
Use of intervention skills
Outcomes evaluation




QOL (EORTC QLQ-C30 and QLQ-H&N35)
Anxiety and depression (HADS)
Evaluated at baseline (prior to therapy), and 1-2
weeks and 3 months after therapy
For home version, program assumed to take one
month from contact with therapist for explanation
Results: Sample sociodemographics
Variables
Intervention
N= 45 (%)
Control
N= 56 (%)
Sex
Male
Female
36 (80.0)
9 (20.0)
39 (69.6)
17 (30.4)
Age
Up to 55 years old
More than 55 years old
22 (48.9)
23 (51.1)
12 (21.4)
44 (78.6)
Level of education
High school or less
College or University
26 (57.8)
19 (42.2)
37 (66.1)
19 (33.9)
Accommodation
With people
Alone
37 (84.1)
7 (15.9)
38 (67.9)
18 (32.1)
Occupation
Retired/working
Unemployed/on sick leave
32 (70.1)
13 (29.9)
49 (87.5)
7 (12.5)
Results: Sample clinical characteristics
Variables
Intervention
N= 45 (%)
Control
N= 56 (%)
Co-morbidity
Presence
Absence
17 (37.8)
28 (62.2)
16 (28.6)
40 (71.4)
Site
Oral cavity
Pharynx
Larynx
Other
8 (17.8)
18 (40.0)
11 (24.4)
8 (17.8)
16 (28.6)
20 (35.7)
14 (25.0)
6 (10.7)
Stage
Early
Late
15 (33.3)
30 (66.7)
20 (35.7)
36 (64.3)
Time since diagnosis
Up to 12 months
12-36 months
20 (44.4)
25 (55.6)
34 (60.7)
22 (39.3)
Treatment
Surgery
Radiotherapy
Combination
2 (4.4)
18 (40)
25 (55.6)
3 (5.4)
12 (21.4)
41 (73.2)
Results: process

Participants vs. non-participants


Numbers choosing each format:

Group: 5%
One-to-one: 56%
Home: 39%

Significantly more males chose home version



Non-participants significantly older
Predictors of home vs. group/one-to-one:


(males 47%; females 8%)
Tendency for younger subjects to chose home
version
Results: process

Drop-outs vs. complete subjects

Drop-outs were more likely to have lower
education (p=0.02):
35% of ≤ high school education
 9% of ≥ college education


Drop-outs more likely to have early stage
disease (p=0.045):
38% of early stage
 16% late stage

Results: QOL - function
% better
% same
% worse
100%
80%
60%
P<0.05
P<0.05
P<0.05
40%
20%
0%
physical
role
emotion
cognition
social
global
Results: QOL - function
Physical functioning
Social functioning
Quality of life
90
70
50
Baseline
1
1st follow-up
2
2nd follow-up
3
Results: Changes in QOL - function
Baseline
Follow-up
100
QOL scores
(higher score =
less problems)
80
P<0.05
P<0.05
60
P<0.05
40
20
0
Interv
Physical
Control
Interv
Social
Control
Interv
Control
Global
Results: QOL - symptoms
% better
% same
% worse
100%
80%
60%
P<0.05
P<0.05
40%
20%
on
ey
m
di
ar
rh
ea
ti
p
co
ns
lo
ss
ap
p
di
st
sl
p
ne
a
dy
sp
pa
in
v
&
n
fa
t
ig
ue
0%
Results: QOL - symptoms
40
30
20
10
0
Baseline
1
1st follow-up
2
2nd follow-up
3
Fatigue
Sleep disturbance
Results: Changes in QOL
Baseline
Follow-up
35
QOL scores
(higher score =
more problems)
30
25
20
15
P<0.05
P<0.05
P<0.05
10
5
0
Interv
Control
Fatigue
Interv
Control
Sleep disturbance
Interv
Control
Financial Impact
Results: HADS (mean scores)
% better
% same
% worse
100%
80%
60%
P<0.05
40%
P<0.05
20%
0%
anxiety
depression
total
Results: HADS (mean scores)
20
Anxiety
Depression
Total HADS
10
0
Baseline
1
1st follow-up
2
2nd follow-up
3
Results: HADS
(categorised into <8 vs. ≥8)
30
25.6
23.1
20
P = 0.11
17.9
% sample affected
before
10.3
10
0
anxiety
depression
% sample affected
after
Results: Changes in depression ratings
Baseline
Percent
possibly
depressed
Follow-up
30
25
20
15
10
5
0
Test group
Control group
Conclusions




Providing a psycho-educational program aimed at
improving coping strategies is feasible
Subjects appeared to prefer the home or one-to-one
format
The choice of format seems to be linked to gender
and age
People who do not complete the study tended to be
less well educated and with early stage disease
Conclusions

Preliminary data suggest the
intervention may lead to:



improved evaluations of certain elements of
QOL; and
Reduced levels of depressive symptoms
Tendency towards reduction in proportion
of people with possible/probable
depression
…….and now for the RCT…….
H&N cancer patient 6-12mths after diagnosis
Recruitment & screening
Randomisation
(those with high HADS scores)
Pasive controls
(those screened out of study)
Test intervention
(complete 4 wks post-random'n)
Placebo intervention
Nothing
8 wk post-random'n evaluation
8 wk post-random'n evaluation
8 wk post-random'n evaluation
4 mth post-random'n evaluation
(primary outcome)
4 mth post-random'n evaluation
(primary outcome)
4 mth post-random'n evaluation
(primary outcome)
8 mth post-random'n evaluation
8 mth post-random'n evaluation
8 mth post-random'n evaluation
14mth post-random'n evaluation
14mth post-random'n evaluation
14mth post-random'n evaluation
2 yr survival analysis
2 yr survival analysis
2 yr survival analysis
…….and now for the RCT…….
Target N=375
Recruitment & screening
Randomisation
(those with high HADS scores)
N=15/250
Observational group
(those screened out of study)
N=21/125
Test intervention (Current N=7/125)
(complete 4 wks post-random'n)
Placebo intervention (current N=8/125)
Nothing
8 wk post-random'n evaluation
N=5/125
8 wk post-random'n evaluation
N=6/125
8 wk post-random'n evaluation
N=16/125
4 mth post-random'n evaluation
(primary outcome)
N=2/125
4 mth post-random'n evaluation
(primary outcome)
N=3/125
4 mth post-random'n evaluation
(primary outcome)
N=11\125
8 mth post-random'n evaluation
N=1/125
8 mth post-random'n evaluation
N=1/125
8 mth post-random'n evaluation
N=4/125
14mth post-random'n evaluation
14mth post-random'n evaluation
14mth post-random'n evaluation
2 yr survival analysis
2 yr survival analysis
2 yr survival analysis
Outcomes


Primary outcome: HADS
Secondary outcomes:








EORTC QLQ C30 and H&N35
Ways of coping questionnaire
Roseberg self-esteem scale
Life orientation test
Risk behaviours (smoking and alcohol consumption)
Medications and use of all therapies
Recurrent cancer and/or second H&N cancer
2 yr survival
Acknowledgements

Financial support of the Canadian Institutes of Health
Research

Therapists: Terrye Pearlman & Carol Archer

Research Assistant: Nathalie Socard

Student: Larissa Vilela

Co-researchers: Linda Edgar, Mike Hier, Marti Black,
Eduardo Franco, Jocelyne Feine, Raghu Rajan, Belinda
Nicolau