Purpose of project-We want to develop, implement and evaluate an 8-session meaning-centered group psychotherapy for Dutch cancer patients, on the basis of Breitbart's intervention, entitled 'Group Training Living Meaningfully with Cancer…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychologische stress bij kankerpatiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:meaning-making
-The Dutch Personal Meaning Profile (39 items) has 5 scales: religion,
dedication to life, fairness of life, goal-orientedness, relationships(*>.80;
sufficient validity) (86).
-The Dutch Post Traumatic Growth Scale (21 items) has 5 scales: relationships,
viewing new possibilities, personal strength, spirituality, appreciation of
life (*>.80; sufficient validity) (87).
-The Dutch Ryff's conceptual wellbeing scale (52 items) has 6 scales: autonomy,
environmental mastery, personal growth, positive relationships, purpose in
life, self-acceptance (*>.80; sufficient validity)(88).
Secondary outcome
The Dutch Hospital Anxiety and Depression Scale(14 items) has two scales:
depression, anxiety(*>.80; sufficient validity)(89).
-The Dutch Beck Hopelessness Scale(20 items) measures hopelessness(*>.80;
sufficient validity) (90).
-The Dutch Life Orientation Test(10 items) measures optimism(*>.80; sufficient
validity) (91).
- The Mental Adjustment to Cancer scale (40 items) measures specific responses
and coping with cancer (*>.80; sufficient validity)
-The Dutch EORTC QLW-C30(30 items) measures tumor-specific health-related
quality-of-life, functioning, and physical symptoms(*>.80; sufficient
validity)(e.g.92).
Economic evaluation
The economic evaluation will be conducted as a cost-utility analysis for
(changes in) health-related quality of life. Patient outcome analysis:
Health-related quality of life will be assessed with help of the EQ-5D (15
items) at baseline and 3, 6 and 12 months follow-up. Direct medical and direct
non-medical cost data are collected with the TIC-P 39 (35 items), a widely used
health service receipt interview in economic evaluations. Unit resource use (GP
visits, hospital days, etc.) will be multiplied by their appropriate integral
cost prices.40 Indirect non-medical cost data related to production losses
through work loss days and work cutback days will be sampled with the
appropriate PRODISQ modules.
Background summary
Background-In the past, when a patient was diagnosed with cancer, this often
meant a short remaining time to live. Nowadays, patients live with cancer for a
longer time. This also implies a shift in the requested psychological help from
palliative/terminal care towards help with finding meaningful ways to continue
their lives, despite physical limitations and uncertainties. Literature shows
that meaning-making is important for cancer-patients: 1.meaning-focused coping
is at the core of adequate adjustment to cancer; 2.despite a lack of
pathological distress, up to 70% of cancer-patients have questions and needs
regarding meaning-making; 3.up to 70% of the patients wish to be helped with
meaning-making; 4.cancer patients who experience their life as meaningful are
better adjusted, have better quality-of-life and psychological functioning.
Most psychological interventions focus at teaching adequate coping and
preventing/treating psychiatric symptoms, and not at living with cancer.There
are few evidence-based interventions to help patients finding ways to live
meaningfully with cancer. Breitbart et al developed an 8-session
meaning-centered group psychotherapy for cancer-patients in New-York, based on
Victor Frankl's logotherapy. The therapy is directed at stimulating the
patients' search for meaning, through creativity, experience, attitude and
legacy, and consists of didactics, discussion and experiential exercises.
Breitbart et al found large improvement in his patients' meaning-making
and psychological functioning. These effects (d=.8) were larger than the small
effects of non-meaning centered psychological interventions. These effects were
also larger than other existential therapies which had small to moderate
effects, possibly because the latter were often relatively
unstructured/non-directive. The effects of Breitbart's therapy may be explained
by its: 1.direct focus at meaning-focused coping and goal reengagement, with
many sources of meaning; 2.structured/manualized approach; 3.actively
stimulating and deepening experiences; 4.practical; 5.providing explanations;
6.unconditional positive regard.
Study objective
Purpose of project-We want to develop, implement and evaluate an 8-session
meaning-centered group psychotherapy for Dutch cancer patients, on the basis of
Breitbart's intervention, entitled 'Group Training Living Meaningfully with
Cancer'.
Purpose of therapy-The therapy purpose is to help patients to find their own
ways to satisfactorily design and live their lives meaningfully within the
context of physical limitations and uncertainty of having cancer. Specific
purposes are: search for meaning (e.g. reordering/evaluating old meanings,
search for new meanings, overcoming practical limitations); concrete
goal-reengagement in daily life; learning to distinguish between what can and
what cannot be changed; integration of cancer in life history; emotional
expression and social support; improved psychological functioning.
Possible results and relevance-An evidence-based, manualized intervention will
be developed to help patients living meaningfully with cancer despite physical
limitations and uncertainty of cancer. This intervention is expected to meet
the meaning-centered needs of cancer-patients more explicitly than other
psychotherapies. A practical therapy manual and therapist training protocol
will be developed for implementation in other centers for
oncological/psychosocial care.
Study design
Plan of investigation-The project will be performed in 5 phases: 1. two focus
groups with 6-12 cancer-patients will be performed, and approval by the
medical-ethical committees will be obtained; 2.translation/adaptation of
therapy and training of therapists, in discussion with an expert-advisory
committee; 3.pilot study in 3 groups of 6-8 patients; 4.randomized controlled
trial(RCT) in 180 patients (60 intervention-condition, 60
social-support-group-condition, 60 care-as-usual-condition); 5.analyses and
generalization phase.
Participants have completed their cancer treatment with curative intent
in the Leiden University Medical Center or VU University Medical Center, and
are able to follow all therapy sessions.
Outcome measures include valid, reliable outcome-measures of meaning-making and
psychological functioning (e.g. personal meaning profile, Ryff's well-being,
HADS). To assess possible determinants of efficacy of the intervention,
sociodemography, comorbidity, cancer, treatment and copingstyles will also be
measured. Questionnaires will be filled-in before the first and after the last
sessions, and 3, 6 and 12 months later. 60 patients are needed in each group at
the baseline, assuming an effect size of .80, compensation for 30% loss to
follow-up, 80% power and 5% p-value. Randomization will be stratified by cancer
site and gender.
Intervention
A detailled description and outcomes of the intervention can be found in:
Breitbart et al, Psycho-Oncology, 2010. Our intervention is a translation of
this study to the situation of Dutch cancer-survivors. The intervention
consisted of didactics, discussion and experiential exercises focusing around
themes related to meaning and advanced cancer. The therapists focused on the
group members' own experiences that are consonant with a sense of
meaningfulness, and avoided imposing their theory on them. Group members had
the possibility to express emotions and to support each other, but this was
limited, to focus on the exercises, didactics and discussions.
Countertransference issues experienced by the psychotherapists were discussed
in intervision/supervision. Homework included experiential exercises to do
individually or together with relatives/friends, and texts to read (mainly from
Frankl). Each session addressed a specific theme: introduction to meaning and
the impact of cancer(1-2), historical meanings(3-4), sources of meaning(5-7),
and termination(8). See details about the intervention in the research
protocol.
Social-support condition
We assume MCGP is mainly effective because of its specific focus at
meaning-making and its structured/manualized nature. Therefore, we want to
create a control-condition identical to the MCGP, except for these two
elements. The control-condition is a social-support group psychotherapy,
following Payne et al as used by Breitbart et al. See details about the control
group in the research protocol.
Study burden and risks
We expect that there are no health risks for participants in this study.
I. Focus grou phase- In the focus groups, the participants discuss what they
experience as the most important psychological developments since the diagnosis
of their cancer, and they describe which kind of help they would like to have
received. We expect that this self-reflection is not an additional psychosocial
burden for the participants; we base the assumption on our previous experience
with focus groups and questionnaires in this populations; the participating
cancer patients said that they enjoyed participation, and that it helped them
to look back on their psychological experiences.
II. Pilot study and randomized controlled trial fases van de studie. We expect
that cancer patients who participate in this intervention, are better able to
cope with their questions about meaning in life that may be evoked by the
diagnosis of cancer. Consequently, the psychopathological symptoms -such as
distress, depression, suicidality or the wish for a hastened death- are
expected to decrease. We expect that participants in the control groups (both
the social support group and the no-intervention group) will not experience
distress or other kinds of psychosocial burden as a consequence of
participation in this stuy. All these expectations have been based on studies
performed in the Memorial Kettering Sloan Hospital in New York (see: Breitbart
et al, Psycho-Oncology, 2010).
Participation may consist of one of the following parts of our study:
(1) focusgroups (max. 12 persons); (2) pilot study (24 persons); (3) randomized
controlled trial with a (a) intervention group (training 'Living meaningfully
with cancer'), (b) social support control group, (c) no intervention. The
participants of the focus groups participate in one discussion meeting in which
we discuss their vision about the basic elements of the intervention. The
participants in the pilot study follow eight training/therapy sessions of each
2 hours; at the end of each session, they fill-in a short evaluation form.
Before the first session they fill in one questionnaire and after the last
session they fill in four questionnaires. The participants of the social
support group receive eight training/therapy sessions of each 2 hours; before
the first session they fill in one questionnaire and after the last session
they fill in four questionnaires. The participants in the no-intervention
control-group only fill-in five questionnaires. Filling-in these questionnaires
takes about 30 to 45 minutes, the fifth queastionnaire takes 15 minutes.
van der Boechorststraat 1
AMSTERDAM 1081 BT
NL
van der Boechorststraat 1
AMSTERDAM 1081 BT
NL
Listed location countries
Age
Inclusion criteria
received treatment with curative intent for cancer less then 5 years ago
18 years or older
need for help with psychosocial problems(e.g. anxiety, meaning-making, life questions, depressive symptoms, coping)
Exclusion criteria
(severe) coginitive disorders
receiving psychological treatment
no mastery of dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL34814.058.10 |