Evidence map›Paper›PMID 38663007›Full record

Trial reportJournal of medical Internet research2024

Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial.

Franziska Springer, Ayline Maier, Michael Friedrich, Jan Simon Raue, Gandolf Finke, Florian Lordick, Guy Montgomery, Peter Esser, Hannah Brock, Anja Mehnert-Theuerkauf

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Franziska Springer *Department of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0002-1586-4050
Ayline Maier *Fosanis GmbH, Berlin, Germany.ORCID 0000-0001-9813-3263
Michael FriedrichDepartment of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0002-0528-1564
Jan Simon RaueFosanis GmbH, Berlin, Germany.ORCID 0000-0001-5209-1213
Gandolf FinkeFosanis GmbH, Berlin, Germany.ORCID 0000-0002-2723-3504
Florian LordickDepartment of Medicine II, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0001-8591-9339
Guy MontgomeryCenter for Behavioral Oncology, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, United States.ORCID 0000-0002-3779-4145
Peter EsserDepartment of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0002-4944-8020
Hannah BrockDepartment of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0002-9905-9488
Anja Mehnert-TheuerkaufDepartment of Medical Psychology and Medical Sociology, Comprehensive Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany.ORCID 0000-0002-6872-9805
Icahn School of Medicine at Mount Sinai · USUniversity Hospital Leipzig · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDistress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes.

objectiveThis study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory.

methodsThis nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline.

resultsA total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life.

conclusionsMika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care.

trial registrationGerman Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

Indexed as

NeoplasmsAdultAgedFatigueFemaleGermanyHumansMaleMiddle AgedMobile ApplicationsQuality of LifeStress, PsychologicalWaiting Listsaccess to careanxietyappcancerdepressiondigital healthdigital therapeuticdistressfatiguemobile healthmobile phoneoncologyrandomized controlled trialsupportive care

Identifiers

PMID38663007
PMCPMC11082740
OpenAlexW4392107943

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.