1) To identify factors that predict resilient functioning.2) To study whether (in line with Fredrickson's broaden & built theory) the ability to experience positive emotions in response to a pleasant event predicts few psychosocial…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A week before participants start with ESM, they will complete several baseline
questionnaires. During a two-week period participants are asked to complete ESM
eight times per day via an app on their phone. Positive affect, negative
affect, daily life events, predictors (i.e. fatigue, pain, emotion regulation
and coping), and contextual predictors (i.e. location and company) will be
measured in these ESM items. Analyses will be conducted separately for two
resilience outcomes (recovery and reward experience). For each model, potential
predictors (baseline predictors, momentary predictors, contextual predictors)
will be entered as moderators.
Secondary outcome
The secondary objective in this study is to explore whether reward response
despite adversity (i.e. advanced cancer diagnosis) predicts low psychosocial
distress (symptoms of depression and anxiety) and more illness acceptance,
tolerance of uncertainty, mindfulness, optimism and perceived social support a
year after measuring resilience in daily life. To explore this, participants
will complete a follow-up questionnaire approximately a year after completing
the ESM items. This questionnaire contains items about psychosocial distress,
illness acceptance, tolerance of uncertainty, mindfulness, optimism, and
perceived social support.
Background summary
Getting a diagnosis of advanced melanoma or advanced lung cancer can have a
huge impact on everyday life. First, patients are told that the cancer is (most
likely) incurable. Then immunotherapy or targeted therapy appears to be
successful, extending life for an unknown period of time. We do know that the
resilience of these patients is repeatedly challenged. The confrontation with a
poor prognosis, followed by the news of treatment options that can prolong
their life for an uncertain amount of time can be a lot to take in. They need
to adjust to a new way of life in which death is a continuous threat, while
being repeatedly confronted with uncertainties and other stressors. Several
effective psychological therapies are available for cancer patients suffering
from psychopathology. But can we also support this specific group of patients
to handle these continuing stressors and potentially prevent psychopathology?
Improving patients* resilience will offer a valuable first step in patients*
mental healthcare.
Study objective
1) To identify factors that predict resilient functioning.
2) To study whether (in line with Fredrickson's broaden & built theory) the
ability to experience positive emotions in response to a pleasant event
predicts few psychosocial complaints, more acceptance of illness, more
experienced social support, more optimism, more mindfulness and more
uncertainty tolerance one year after measuring resilience in long-term
responders.
Study design
For this intensive longitudinal observational study we will gather quantitative
data using Experience Sampling Method (ESM).
Study burden and risks
Participating in the study could provide insight for participants in what
factors help them to function resiliently. By participating, patients are able
to help future patients to function resiliently. Potential burden is that it
costs participants quite some time (approximately five hours in total).
Additionally, the information and ESM items could evoke emotions for some
participants. Therefore, participants will be provided with the researcher*s
contact details, with whom they can discuss where and how they can receive
appropriate care in case necessary.
Biezenstraat 24
Nijmegen 6541ZT
NL
Biezenstraat 24
Nijmegen 6541ZT
NL
Listed location countries
Age
Inclusion criteria
- diagnosed with stage IV melanoma with confirmed response to or long-term
stable disease while on immunotherapy;
- or stage IV lung cancer with confirmed response to or long-term stable
disease while on immunotherapy or targeted therapy.
We consider a response confirmed after the second scan shows that patients
respond well (i.e. RECIST at least partial response or >1 year of stable
disease) to one of both therapies.
Exclusion criteria
- <18 years of age;
- not able to sufficiently use and understand the Dutch language;
- have no smartphone or internet access.
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 |
|---|---|
| CCMO | NL78416.028.21 |