scholarly journals A Smartphone App–Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial

10.2196/15178 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e15178 ◽  
Author(s):  
Utkarsh B Subnis ◽  
Norman AS Farb ◽  
Katherine-Ann Laura Piedalue ◽  
Michael Speca ◽  
Sasha Lupichuk ◽  
...  
Keyword(s):  
Cancer Survivors ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Smartphone App ◽  
Cancer Treatments ◽  
Mindfulness Intervention ◽  
Fear Of Cancer ◽  
Anxiety Depression

Background Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. Objective The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. Results The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. Conclusions Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. Trial Registration ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 International Registered Report Identifier (IRRID) DERR1-10.2196/15178

scholarly journals A Smartphone App–Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Utkarsh B Subnis ◽  
Norman AS Farb ◽  
Katherine-Ann Laura Piedalue ◽  
Michael Speca ◽  
Sasha Lupichuk ◽  
...  
Keyword(s):  
Cancer Survivors ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Smartphone App ◽  
Cancer Treatments ◽  
Mindfulness Intervention ◽  
Fear Of Cancer ◽  
Anxiety Depression

BACKGROUND Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. OBJECTIVE The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the <i>Am</i> Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. METHODS This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of <i>Am</i> MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. RESULTS The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. CONCLUSIONS Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. CLINICALTRIAL ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15178

scholarly journals Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors: study protocol of a randomized controlled trial (MATCH-study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Susan J. Harnas ◽  
Hans Knoop ◽  
Floor Bennebroek Evertsz ◽  
Sanne H. Booij ◽  
Joost Dekker ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Cognitive Behavioral Therapy ◽  
Cancer Survivors ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cancer Recurrence ◽  
Cognitive Behavioral ◽  
Fear Of Cancer Recurrence ◽  
Cancer Related Fatigue ◽  
Fear Of Cancer

Abstract Background Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients’ quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. Methods The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients’ needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). Discussion To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. Trial registration The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019.

scholarly journals Perilla Oil and Bifidobacterium for Alleviating Fear of Cancer Recurrence in Breast Cancer Survivors: Study Protocol for a Three-Arm Phase II Randomized Controlled Study (POB Study)

2021 ◽  
Vol 4 (3) ◽  
pp. 46
Author(s):  
Yohei Sasaki ◽  
Mina Honyashiki ◽  
Takayuki Kinoshita ◽  
Akira Matsui ◽  
Ayako Nakashoji ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Phase Ii ◽  
Study Protocol ◽  
Breast Cancer Survivors ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Randomized Controlled ◽  
Perilla Oil ◽  
Fear Of Cancer

The fear of cancer recurrence (FCR) is the most common and most severe unmet need among cancer survivors. Safe treatments for the FCR that are easily disseminated are greatly needed. Our primary aim is a preliminary evaluation of the efficacy and effect size of perilla oil, which is rich in omega-3 fatty acids, and Bifidobacterium, a probiotic, on FCR in breast cancer survivors after the completion of chemotherapy. This study has been planned as an exploratory clinical study (phase II) and will be conducted as a three-arm, 12-week parallel group, masked-rater randomized controlled trial. Fifteen participants will be randomized with 1:1:1 allocation to receive Bifidobacterium plus perilla oil, Bifidobacterium alone, or no intervention (control). Interventions will end within 12 weeks after the random allocation of each participant. The participants will be outpatients with invasive breast cancer aged 20 years or older whose chemotherapy was completed at least 6 months before registration; hormone therapy may be ongoing. The primary outcome will be severity of FCR at 12 weeks assessed by masked raters using the 4-item Concerns about Recurrence Scale concerning overall fear of recurrence. The study protocol for the current study is registered in the Japan Registry of Clinical Trials (jRCTs031200029).

scholarly journals Fear of cancer recurrence among cancer survivors in Singapore

2020 ◽  
Author(s):  
R Mahendran ◽  
JL Liu ◽  
S Kuparasundram ◽  
S Simard ◽  
YH Chan ◽  
...  
Keyword(s):  
Cancer Survivors ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Fear Of Cancer
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