Evidence map›Paper›PMID 39709459›Full record

ArticlePilot and feasibility studies2024

PTSD Coach as an early mobile intervention to improve cancer-related anxiety and psychosocial oncology uptake in patients newly diagnosed with head and neck cancer: pilot randomized controlled trial.

Laurence Ducharme, Chris Lo, Michael Hier, Anthony Zeitouni, Karen Kost, Alex Mlynarek, Michael Antoni, Eric Kuhn, Jason E Owen, Daren Heyland and 9 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03651570 (Implementing an e-Intervention to Reduce Anxiety Symptoms and Improve Psychosocial Oncology Uptake in Patients Newly Diagnosed With Head and Neck Cancer), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03651570 naunknown statusnot on this map

Implementing an e-Intervention to Reduce Anxiety Symptoms and Improve Psychosocial Oncology Uptake in Patients Newly Diagnosed With Head and Neck Cancer: Pilot Randomized Controlled Trial

TypeinterventionalSponsorJewish General HospitalRan2018 to 2020Enrolled60ConditionsHead and Neck CancerArmsPTSD Coach, Game application
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

19 authors.

Laurence DucharmeLady Davis Institute for Medical Research, Montreal, QC, Canada. laurence.ducharme@mail.mcgill.ca.ORCID http://orcid.org/0009-0002-2703-7308
Chris LoSchool of Social and Health Sciences, Tropical Futures Institute, James Cook University, Singapore, Singapore.
Michael HierDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Anthony ZeitouniDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Karen KostDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Alex MlynarekDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Michael AntoniDepartment of Psychology, University of Miami, Miami, FL, USA.
Eric KuhnDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
Jason E OwenDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
Daren HeylandDepartment of Medicine and Epidemiology, Queen's University, Kingston, ON, Canada.
Robert PlattDepartment of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
Fabienne FuehrmannDepartment of General Psychiatry, KRH Psychiatry GmbH, Wunstorf, Germany.
Nader SadeghiDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Zeev RosbergerLady Davis Institute for Medical Research, Montreal, QC, Canada.
Saul FrenkielDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Khalil SultanemGerald Bronfman Department of Oncology, McGill University, Montreal, QC, Canada.
George ShenoudaDepartment of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Fabio CuryGerald Bronfman Department of Oncology, McGill University, Montreal, QC, Canada.
Melissa HenryLady Davis Institute for Medical Research, Montreal, QC, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis pilot study aimed to provide supportive evidence for the feasibility of conducting a full-scale intervention trial with patients newly diagnosed with head and neck cancer (HNC). This included assessing the acceptability and potential usefulness of the PTSD Coach mobile app as an early self-management intervention that gives information about anxiety symptoms, offers self-assessment of symptoms with feedback, tools to self-manage anxiety, and connects to support.

methodsA three-arm randomized controlled trial was conducted. The primary pilot study questions related to feasibility were: (1) can we recruit enough (i.e., n = 60 over 8 months or 8/month) and retain a sufficient proportion (i.e., ≥ 85% at three months post-randomization, having completed the primary outcome) of patients with HNC in all trial arms? (2) Will there be at least a 90% completion rate of PTSD Coach within 3 weeks from randomization? (3) Will at least 85% of the content for each module of PTSD Coach be completed? (4) Will there be at least a 90% completion rate of the attention-control tasks (i.e., 45 min/week over 3 weeks)? (5) What would be the anticipated sample size for a full study? (6) We also explored a signal for intervention effects on 1-, 3-, and 6-month levels of cancer-related anxiety, quality of life, anxiety and depression, self-stigma of seeking help, and professional psycho-oncology service uptake.

resultsParticipants comprised 39 patients (11 experimental group (EG), 13 attention-control (AC), 15 usual care (UC)), primarily male (82%). Enrolment was lower than expected, with strategies implemented to increase the study's participation rate (i.e., shortening the questionnaire, more relevant AC games, pacing study components, and enlarging eligibility to 4 weeks post-diagnosis instead of 2). Retention rates, intervention completion rates, and completion time were adequate. The intervention was acceptable with all patients (100%) who received PTSD Coach reporting it a positive experience and that they would recommend it to others. When compared to UC, there was a signal for the PTSD Coach group to report lower 3-month cancer-related anxiety (PCL-S; eta squared = 0.013), lower anxiety and depression (HADS; eta squared = 0.015), anxiety (HADS-A; eta squared = 0.028), and higher functional wellbeing (FACT-FW; eta squared = 0.09), based on effect sizes calculated across all three groups. The sample size for a full study was estimated to be 118 to 154 per group.

conclusionA repeat pilot study with an expanded oncology population is warranted to further investigate feasibility prior to a full Phase III study. PTSD Coach could be a valuable self-management tool as an initial stepped-care approach intervention in patients newly diagnosed with HNC.

trial registrationClinicalTrials.gov, NCT03651570 . Registered June 26, 2018.

Indexed as

E-interventionHead and neck cancerM-healthMobile applicationOncologyPsychosocial uptakePTSDPTSD CoachSelf-management

Identifiers

PMID39709459
PMCPMC11662848

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Registered trials

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.