Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions.

BACKGROUND: One-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]). OBJECTIVE: This study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual). METHODS: Women diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway-initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries. RESULTS: Recruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled. CONCLUSIONS: The CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments. TRIAL REGISTRATION: Clinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47195.

Late Adverse Health Outcomes and Quality of Life after curative radiotherapy + long-term ADT in Prostate Cancer Survivors: Comparison with men from the general population.

Background: Few studies have described the impact of urinary, bowel and sexual Adverse Health Outcomes (AHOs) on Quality of Life (QoL) in Prostate Cancer Survivors living for more than 5 years after curative radiotherapy ("long-term PCaSs"), and compared the findings with those in men from general population. Here we assess self-reported AHOs in such PCaSs focusing on the association between problem experience and QoL. The findings are compared to corresponding symptoms in age-similar men from the general population without a PCa diagnosis (Norms). Methods: Nine years (mean) after curative radiotherapy 1231 PCaSs and 3156 Norms completed the EPIC-26 questionnaire and the EORTC QLQ-C30 instrument. Domain Summary Scores (DSSs) for the urinary, bowel and sexual domains, the percentages of moderate/big dysfunctions and the proportions of overall problems were determined. Inter-cohort differences were interpreted based on cut-off values for published Minimal Clinically Important Differences (MCIDs). Multivariable linear regression models analyzed the associations between QoL and domain-related overall problems. Results: Only the inter-cohort differences regarding bowel and sexual DSSs exceeded the respective MCIDs. Among PCaSs 54% had at least one moderate/big problem (Norms: 30%). In PCaSs and Norms, QoL increased with decreasing urinary and bowel problems, For sexuality this association was weaker in Norms and was almost lacking in PCaSs. Multivariable-adjusted QoL was similar in PCaSs and Norms, with general health being the strongest covariate. Conclusions: During follow-up of long-term PCaSs health professionals should be aware of the survivors' persisting moderate/big urinary, bowel or sexual problems associated with reduced QoL. In particular , alleviation of urinary and bowel problems can increase the men's QoL.