Developing and evaluating an online platform for stage 4 cancer patients with a durable response to immunotherapy or targeted therapy.
ID
Source
Brief title
Condition
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of this study is to develop and evaluate an online platform for
advanced cancer patients who obtain durable response to IT or TT in co-creation
with patients, psychologists and service providers. Endpoints will be studied
in the evaluation phase.
We will examine the feasibility of the platform by assessing patients* usage of
the platform during the first month they gained access to it. We will assess
login frequency and activity on the platform using Google Analytics. Frequency
refers to the number of visits per patient during the 1-month period of access
to the platform. Activity refers to the number of opened ingredients
(information, tasks, tests, videos) per patient. We will assess usability (i.e.
the appropriateness of the platform to its purpose) via a self-reported
outcome, the so-called System Usability Scale (SUS), which has often been used
to assess the usability of websites and categorizes them as either poor, okay,
good or excellent. This gives an indication of how easy to use and satisfactory
the platform is and how likely patients are to return. Moreover, we will assess
the extent to which the information and content by employing a custom made
questionnaire. This questionnaire will inquire about the coverage of essential
topics relevant to patients within the platform.
We will track how many people who meet the eligibility criteria and are
referred to the study by healthcare professionals and how many of them want to
participate in the study and test the platform.
Qualitative semi-structured interviews will provide us with additional
information about experiences of patients (and potentially of their close
others) with using the platform, and if so, how it was helpful to them.
Secondary outcome
In order to examine the effects of utilizing the platform, participants will be
required to fill out baseline and follow-up questionnaires related to their
levels of anxiety, depressive symptoms, and resilience. Anxiety and depressive
symptoms will be measured using the Hospital Anxiety and Depression Scale,
containing 14 items. Resilience will be measured with the Brief Resilience
Scale, which consists of 6 items exploring the extent to which patients in
general quickly recover from adverse events.
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
early in their medical treatment to deal with the continuously present
stressors? We aim to offer this group of patients psychological support early
in their medical treatment through an online platform in which feelings are
normalized and acknowledged and practical tools are offered.
Study objective
Developing and evaluating an online platform for stage 4 cancer patients with a
durable response to immunotherapy or targeted therapy.
Study design
In the development-phase (stage 3), we will make use of an observational cohort
study design. Data will be collected through think-aloud and semi-structured
interviews with 12 participants. As user feedback is gained, changes can be
made to the online platform and then further interviews can be conducted to
check whether the changes made are suitable. The development phase is therefore
best viewed as an iterative cycle moving between user feedback and changes to
the online platform.
In the evaluation-phase (stage 4), we will use a pre-post intervention design.
Data will be collected through questionnaires and interviews with respectively
45 and 15 participants. These participants did not take part in the
development-phase.
Study burden and risks
- Participation will cost time:
• Participating in the development phase will cost patients at least 130
minutes, excluding time they will spent using the platform (questionnaire: 10
minutes; Think-aloud interview: maximum 60 minutes; use prototype; interview
about experiences with prototype: maximum 30 minutes each time).
• Participating in the evaluation phase will cost patients approximately 40
minutes, excluding time they will spent using the platform (baseline
questionnaire: 20 minutes; use platform; follow-up questionnaire: 20 minutes;
and for 15 out of 45 participants an interview about experiences with platform:
maximum of 60 minutes).
- Although the use of the platform can give patients insight into their
situation, recognize and normalize possible difficulties and provide tools on
how to deal with the challenges, it is possible that this can evoke emotions.
For this reason, participants receive instructions to contact their healthcare
provider and a phone number of the researcher is provided in the invitation
letter and the questionnaire to discuss how/where the participant can receive
appropriate care.
Biezenstraat 24
Nijmegen 6541ZT
NL
Biezenstraat 24
Nijmegen 6541ZT
NL
Listed location countries
Age
Inclusion criteria
Patients are diagnosed with stage IV 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 internet access.
Design
Recruitment
Medical products/devices used
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 | NL85889.028.23 |