Ducharme, Laurence, Lo, Chris, Hier, Michael, Zeitouni, Anthony, Kost, Karen, Mylinarek, Alex, Antoni, Michael, Kuhn, Eric, Owen, Jason E., Heyland, Daren, Platt, Robert, Fuehrman, Fabienne, Sadeghi, Nader, Rosberger, Zeev, Frenkiel, Saul, Sultanem, Khalil, Shenouda, George, Cury, Fabio, and Henry, Melissa (2024) 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. Pilot and Feasibility Studies, 10. 153.

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Abstract

Background: This 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.

Methods: A 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.

Results: Participants 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.

Conclusion: A 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.

Item ID:	84447
Item Type:	Article (Research - C1)
ISSN:	2055-5784
Copyright Information:	© The Author(s) 2024. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
Date Deposited:	20 Jan 2025 04:19
FoR Codes:	52 PSYCHOLOGY > 5203 Clinical and health psychology > 520302 Clinical psychology @ 50% 52 PSYCHOLOGY > 5203 Clinical and health psychology > 520304 Health psychology @ 50%
SEO Codes:	20 HEALTH > 2001 Clinical health > 200105 Treatment of human diseases and conditions @ 100%
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