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. 2023 May 24:12:e47195.
doi: 10.2196/47195.

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

Karianne Svendsen  1   2   3 , Lise Solberg Nes  4   5   6 , Anders Meland  7 , Ine Marie Larsson  1 , Ylva M Gjelsvik  1 , Elin Børøsund  4   8 , Christine M Rygg  4 , Tor Åge Myklebust  1 , Kristin V Reinertsen  9 , Cecilie E Kiserud  9 , Helle Skjerven  10 , Michael H Antoni  11 , Trudie Chalder  12 , Ingvil Mjaaland  13 , Linda E Carlson  14   15 , Hege R Eriksen #  16 , Giske Ursin #  1   2   17
Affiliations

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

Karianne Svendsen et al. JMIR Res Protoc. .

Abstract

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.

Keywords: RCT; StressProffen; breast cancer; cognitive behavioral therapy; digital; eHealth; intervention; mindfulness; psychosocial; stress management.

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Conflict of interest statement

Conflicts of Interest: KS, AM, IML, EB, CMR, YMG, TÅM, HS, KVR, IM, CEK, and GU declare no conflicts of interest. LSN is an unpaid board member of dHealth AS, a company aiming to commercialize the original StressProffen program. TC is Co-chief investigator on a National Institute for Health and Care Research (NIHR) program grant in the UK testing a modified acceptance and commitment therapy intervention to improve quality of life for people with a range of cancers in the posttreatment phase. MHA is a consultant for Blue Note Therapeutics and Atlantis Healthcare, both digital health software companies. LEC receives royalties for 2 mindfulness book titles, and from eMindful for an online mindfulness-based cancer recovery program. HRE is a co-founder and a shareholder of a company offering lectures, education, and supervision about stress and coping (Stressprofessorene AS). HRE has no commercial interest in the StressProffen program.

Figures

Figure 1
Figure 1
Overview of milestones in the CABC RCT. Study baseline is approximately 7 months after breast cancer diagnosis. Eligible participants who have completed the CRN PROMs survey, consented to the CABC study, and completed baseline questionnaires are randomized to either the StressProffen-CBI, StressProffen-MBI or a control group (TAU). Recruitment is scheduled from January 2020 to May 2023. Pictures from colourbox.com and StressProffen. CRN PROMs survey: The Cancer Registry of Norway Patient Reported Outcome Measures; CABC: Coping After Breast Cancer; CBI: cognitive behavioral intervention; MBI: mindfulness-based intervention; NBCR: Norwegian Breast Cancer Registry; RCT: randomized controlled trial; TAU: treatment as usual.
Figure 2
Figure 2
Flowchart of inclusion of study participants invited ≈7 months after diagnosis. CBI: cognitive behavioral intervention. MBI: mindfulness-based intervention.
See this image and copyright information in PMC

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