A Digital Intervention to Address Sexual Health in Hematopoietic Stem Cell Transplant Survivors
Harvard Medical School, Boston, MA
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Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA
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Department of Psychology, Dana-Farber Cancer Institute, Boston, MA
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Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA
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Background: Interventions to address sexual health in hematopoietic stem cell transplant (HSCT) survivors are limited. Methods: We conducted a pilot randomized trial of a digital app, SHIFT (Sexual Health and Intimacy Following Transplant), to address sexual dysfunction in HSCT survivors who were ≥3 months post autologous or allogeneic HSCT. Patients were randomly assigned to SHIFT or enhanced usual care. All participants first underwent a brief physical examination by a trained HSCT clinician. Participants assigned to the intervention received access to SHIFT for 8 weeks. SHIFT consists of 5 modules addressing the biological, interpersonal, social, and psychological causes of sexual dysfunction. The primary endpoint was feasibility, defined a priori as ≥60% enrollment of eligible patients, and 60% of those assigned to SHIFT completing ≥70% of the modules. We assessed patient satisfaction with sex, interest in sex, orgasm pleasure (using the Patient-Reported Outcomes Measurement Information System [PROMIS]), quality of life (QoL; using the Functional Assessment of Cancer Therapy – Bone Marrow Transplant [FACT-BMT]), and anxiety and depression symptoms (using the Hospital Anxiety and Depression Scale [HADS]) at baseline, 8 weeks, and 12 weeks. The preliminary effects of SHIFT on study outcomes were explored using analysis of covariance (ANCOVA) and estimates of effect size at 8 weeks (Cohen’s d). Results: We enrolled 64.2% (61/95) of eligible patients. Of those assigned to the intervention, 70.0% completed 4 of the 5 SHIFT modules and 66.7% completed all SHIFT modules. At 8 weeks, SHIFT participants reported improved satisfaction with sex (14.6 vs 12.3; d=0.46), interest in sex (6.7 vs 5.7; d=0.59), orgasm pleasure (9.7 vs 8.3; d=0.37), QoL (115.6 vs 108.3; d=0.45), and symptoms of anxiety (4.5 vs 6.4; d=0.47) and depression (3.6 vs 5.4; d=0.62) compared with the control group. Conclusions: The SHIFT digital app to address sexual dysfunction demonstrated feasibility and promising preliminary efficacy in improving sexual health outcomes, QoL, and psychological distress for HSCT survivors.
Submitted July 6, 2024; final revision received September 22, 2024; accepted for publication September 26, 2024.
Author contributions: Study concept & design: El-Jawahri, Temel. Data acquisition: El-Jawahri, Traeger, Dizon, Cutler, Greer, Vanderklish, Cronin, Reynolds, Rice, Clay, Newcomb, DeFilipp, Ho, Soiffer, Chen, Temel. Data analysis & interpretation: El-Jawahri, Reese, Traeger, Dizon, Cutler, Bober, Greer, Vanderklish, Rabideau, Cronin, Reynolds, Ufere, Rice, Clay, Newcomb, DeFilipp, Pensak, Chen, Temel. Statistical analysis: El-Jawahri. Funding acquisition: El-Jawahri. Administrative, technical, or material support: El-Jawahri, Traeger, Temel. Study supervision: El-Jawahri, Temel. Manuscript—original draft: El-Jawahri, Temel. Critical revision of the manuscript for important intellectual content: All authors.
Disclosures: Dr. El-Jawahri has disclosed serving as a consultant for Incyte Corporation, GSK, Novartis, and Tuesday Health. The remaining authors have disclosed that they have not received any financial considerations from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: This work was supported by funding from National Institute of Nursing Research (5R21NR018234-02; A. El-Jawahri) and Leukemia and Lymphoma Society (Scholar in Clinical Research).
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7076. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
Supplementary Materials
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