International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
Digital therapeutic to improve cancer-related well-being: a pilot randomized controlled trial.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Wolff Josefine, Stupin Jens, Olschewski Jessica, Pirmorady Sehouli Adak, Maier Ayline, Fofana Mariama, Raue Jan Simon, Finke Gandolf, Sehouli Jalid
Аннотация
OBJECTIVE: This randomized waitlist controlled pilot study aimed to evaluate the feasibility and preliminary efficacy of Mika, an app-based digital therapeutic intervention hypothesized to improve management and the support of cancer patients.
METHODS: Patients with gynecological malignancies undergoing post-operative or routine outpatient chemotherapy were randomized (5:2) into intervention (Mika plus treatment-as-usual) and control (treatment-as-usual alone). Feasibility outcomes including dropout rate, reasons for dropout, and intervention adherence, as well as efficacy outcomes including depression, fatigue, and health literacy were assessed at baseline, 4, 8, and 12 weeks. Changes in efficacy outcomes from baseline to week 12 were evaluated in the intervention group only by means of Wilcoxon signed-rank tests.
RESULTS: Seventy participants (intervention group, n=50; control group, n=20) with gynecological cancer (ovarian, cervical, and endometrial) were randomized. The dropout rate increased from 15.7% (11/70) between baseline and week 4 to 37.1% (26/70) between weeks 8 and 12. Primary reasons for dropout were death (n=10) and health status deterioration (n=11). The initial high intervention adherence observed between baseline and week 4 (86% usage rate, average usage time: 120 min, average number of logins: 16.7) declined in weeks 8 to 12 (46% usage rate, average usage time: 41 min, average number of logins: 9). Participants in the intervention group showed significant intra-individual reductions in depressive symptoms by 42% (d=0.85) and fatigue symptoms by 23.1% (d=0.5) from baseline to 12 weeks.
CONCLUSIONS: This pilot study provides initial evidence of the feasibility and efficacy of Mika in improving the well-being of cancer patients. The high initial intervention adherence and significant reductions in depressive and fatigue symptoms suggest that Mika has the potential to improve the management and support of cancer patients.
TRIAL REGISTRATION: German Clinical Trials Register (DRKS) ID: DRKS00023791; retrospectively registered on February 24, 2022.
METHODS: Patients with gynecological malignancies undergoing post-operative or routine outpatient chemotherapy were randomized (5:2) into intervention (Mika plus treatment-as-usual) and control (treatment-as-usual alone). Feasibility outcomes including dropout rate, reasons for dropout, and intervention adherence, as well as efficacy outcomes including depression, fatigue, and health literacy were assessed at baseline, 4, 8, and 12 weeks. Changes in efficacy outcomes from baseline to week 12 were evaluated in the intervention group only by means of Wilcoxon signed-rank tests.
RESULTS: Seventy participants (intervention group, n=50; control group, n=20) with gynecological cancer (ovarian, cervical, and endometrial) were randomized. The dropout rate increased from 15.7% (11/70) between baseline and week 4 to 37.1% (26/70) between weeks 8 and 12. Primary reasons for dropout were death (n=10) and health status deterioration (n=11). The initial high intervention adherence observed between baseline and week 4 (86% usage rate, average usage time: 120 min, average number of logins: 16.7) declined in weeks 8 to 12 (46% usage rate, average usage time: 41 min, average number of logins: 9). Participants in the intervention group showed significant intra-individual reductions in depressive symptoms by 42% (d=0.85) and fatigue symptoms by 23.1% (d=0.5) from baseline to 12 weeks.
CONCLUSIONS: This pilot study provides initial evidence of the feasibility and efficacy of Mika in improving the well-being of cancer patients. The high initial intervention adherence and significant reductions in depressive and fatigue symptoms suggest that Mika has the potential to improve the management and support of cancer patients.
TRIAL REGISTRATION: German Clinical Trials Register (DRKS) ID: DRKS00023791; retrospectively registered on February 24, 2022.