How to improve informal interventions The impact of counselling by thebest11

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									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                     Outcomes
       Group/individual therapy          Anxiety
       Therapist/non therapist           Depression
       With significant other            Affect
       Info’ & education                 Hostility
       Un/structured counseling          Stress/distress
       Relaxation                        QOL/functioning
       Cognitive/behavioural             Coping/control
        therapy                           Social adjustment
       Hypnosis                          Survival
       Music            etc.             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        (Katz et
al, 2004)

   Short-term psycho-educational program
   Delivered by nurse preoperatively and pre-
    discharge
   Pilot study
   Randomised design
   10 test intervention
   9 standard care
   3 month follow-up
   Multiple outcomes
Intervention studies in H&N cancer         (Katz et
al, 2004)




   Results:
       Test group had knowledge change
       Test group had less body image disturbance
       Test group has lower anxiety
Now our work! Study aims
1.       To assess the feasibility of providing a
         psycho-educational program for patients
         with H&N cancer in one of 3 formats:
          One-to-one with therapist
          Small group (3/4 people) with therapist
          Home alone version, without therapist
2.       To generate preliminary outcomes data for
         use in developing the protocol for a RCT of
         the intervention
3.       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
       Book
       Audio cassette or CD
   One-to-one format
       2-3 one or two-hour sessions with therapist
       Partner may be present
   Group format
       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    Control
                                N= 45 (%)     N= 56 (%)

   Sex
    Male                        36 (80.0)     39 (69.6)
    Female                      9 (20.0)      17 (30.4)
   Age
    Up to 55 years old          22 (48.9)     12 (21.4)
    More than 55 years old      23 (51.1)     44 (78.6)
   Level of education
     High school or less        26 (57.8)     37 (66.1)
     College or University      19 (42.2)     19 (33.9)
   Accommodation
    With people                 37 (84.1)     38 (67.9)
    Alone                        7 (15.9)     18 (32.1)
   Occupation
    Retired/working             32 (70.1)     49 (87.5)
    Unemployed/on sick leave    13 (29.9)      7 (12.5)
Results: Sample clinical characteristics
   Variables              Intervention      Control
                           N= 45 (%)       N= 56 (%)
   Co-morbidity
     Presence              17 (37.8)       16 (28.6)
     Absence               28 (62.2)       40 (71.4)
   Site
     Oral cavity            8 (17.8)       16 (28.6)
     Pharynx               18 (40.0)       20 (35.7)
     Larynx                11 (24.4)       14 (25.0)
     Other                  8 (17.8)        6 (10.7)
   Stage
    Early                  15 (33.3)       20 (35.7)
    Late                   30 (66.7)       36 (64.3)
   Time since diagnosis
     Up to 12 months       20 (44.4)       34 (60.7)
     12-36 months          25 (55.6)       22 (39.3)
   Treatment
    Surgery                 2 (4.4)         3 (5.4)
    Radiotherapy            18 (40)        12 (21.4)
    Combination            25 (55.6)       41 (73.2)
Results: process
   Participants vs. non-participants
       Non-participants significantly older
   Numbers choosing each format:
       Group: 5%
       One-to-one: 56%
       Home: 39%
   Predictors of home vs. group/one-to-one:
       Significantly more males chose home version
            (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%
                                                            P<0.05
        P<0.05                                     P<0.05
 60%

 40%

 20%

 0%
       physical   role       emotion   cognition   social   global
Results: QOL - function
                     Physical functioning
                     Social functioning
                     Quality of life
     90



     70



     50
          Baseline   1st follow-up          2nd follow-up
               1              2                 3
  Results: Changes in QOL - function

                                               Baseline    Follow-up


                  100

QOL scores
(higher score =
                   80
less problems)
                        P<0.05
                                             P<0.05
                   60
                                                                       P<0.05
                   40


                   20


                    0
                         Interv    Control    Interv       Control     Interv    Control

                        Physical                  Social                    Global
Results: QOL - symptoms
                               % better     % same        % worse

100%

80%
         P<0.05                             P<0.05
60%

40%

20%

 0%
                                            st
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Results: QOL - symptoms

   40

   30

   20

   10

    0
           1
        Baseline            2
                   1st follow-up         3
                                   2nd follow-up


                                                   Fatigue
                                                   Sleep disturbance
  Results: Changes in QOL
                                       Baseline       Follow-up
                  35




                  30

QOL scores
(higher score =
                  25
more problems)

                  20




                  15   P<0.05
                                           P<0.05
                  10
                                                                  P<0.05

                   5




                   0
                       Interv    Control     Interv    Control     Interv   Control


                           Fatigue         Sleep disturbance       Financial Impact
Results: HADS (mean scores)
              % better     % same     % worse

 100%

  80%

  60%
                          P<0.05           P<0.05
  40%

  20%

  0%
        anxiety          depression         total
Results: HADS (mean scores)

  20
         Anxiety     Depression       Total HADS


  10




   0
       Baseline    1st follow-up   2nd follow-up
          1              2               3
Results: HADS
(categorised into <8 vs. ≥8)

30
                   25.6
     23.1                 P = 0.11


20          17.9                     % sample affected
                                     before
                          10.3       % sample affected
10                                   after



 0
      anxiety      depression
 Results: Changes in depression ratings

                              Baseline   Follow-up

            30
Percent
possibly    25
depressed   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                                       Pasive controls
                  (those with high HADS scores)                        (those screened out of study)


       Test intervention                 Placebo intervention                     Nothing
(complete 4 wks post-random'n)


8 wk post-random'n evaluation       8 wk post-random'n evaluation     8 wk post-random'n evaluation


4 mth post-random'n evaluation      4 mth post-random'n evaluation    4 mth post-random'n evaluation
      (primary outcome)                   (primary outcome)                 (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                                          Observational group
                          (those with high HADS scores)                             (those screened out of study)
                                     N=15/250                                                 N=21/125


  Test intervention (Current N=7/125)     Placebo intervention (current N=8/125)              Nothing
   (complete 4 wks post-random'n)


    8 wk post-random'n evaluation             8 wk post-random'n evaluation        8 wk post-random'n evaluation
               N=5/125                                   N=6/125                             N=16/125


   4 mth post-random'n evaluation            4 mth post-random'n evaluation        4 mth post-random'n evaluation
         (primary outcome)                         (primary outcome)                     (primary outcome)
              N=2/125                                   N=3/125                              N=11\125


   8 mth post-random'n evaluation            8 mth post-random'n evaluation        8 mth post-random'n evaluation
              N=1/125                                   N=1/125                               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

								
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