Pilot Feasibility Stud. 2024 Dec 21;10(1):153. doi: 10.1186/s40814-024-01556-7.
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.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03651570 . Registered June 26, 2018.
PMID:39709459 | DOI:10.1186/s40814-024-01556-7
