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      • Record: found
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      Assessing an Internet-Delivered, Emotion-Focused Intervention Compared With a Healthy Lifestyle Active Control Intervention in Improving Mental Health in Cancer Survivors: Protocol for a Randomized Controlled Trial

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          Abstract

          Background

          Cancer survivors are vulnerable to experiencing symptoms of anxiety and depression and may benefit from accessible interventions focused on improving emotion regulation. CanCope Mind (CM) was developed as an internet-delivered intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders to improve emotion regulation and support the mental health of cancer survivors.

          Objective

          This protocol aims to provide an outline of the CanCope Study, a trial comparing the efficacy of a Unified Protocol–adapted internet-delivered intervention (CM) designed for cancer survivors compared with an active control condition—an internet-delivered healthy lifestyle intervention, CanCope Lifestyle (CL). The primary aim is to assess and compare the efficacy of both interventions in improving emotion regulation, anxiety and depressive symptoms, and quality of life. The secondary aims involve assessing the mechanisms of the CM intervention.

          Methods

          This trial is a 2-arm randomized controlled trial that allocates cancer survivors to either CM or CL. Both interventions comprise 4 web-based modules and are expected to take participants at least 8 weeks to complete. Participants’ mental and physical health will be assessed via self-reported surveys at baseline (T 0), between each module (T 1, T 2, and T 3), immediately after the intervention (T 4), and at 3-month follow-up (T 5). The study aims to recruit 110 participants who have completed T 4.

          Results

          The CanCope study began recruitment in September 2020. A total of 224 participants have been randomized to the CM (n =110, 49.1%) and CL (n=114, 50.9%) groups.

          Conclusions

          This is one of the first trials to develop and investigate the efficacy of a web-based intervention for cancer survivors that specifically targets emotion regulation.

          Trial Registration

          Australian Clinical Trials ACTRN12620000943943; https://tinyurl.com/b3z9cjsp

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/36658

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          Most cited references74

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Paul A Harris, Robert Taylor, Robert Thielke … (2009)
          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs

            Daniël Lakens (2013)
            Effect sizes are the most important outcome of empirical studies. Most articles on effect sizes highlight their importance to communicate the practical significance of results. For scientists themselves, effect sizes are most useful because they facilitate cumulative science. Effect sizes can be used to determine the sample size for follow-up studies, or examining effects across studies. This article aims to provide a practical primer on how to calculate and report effect sizes for t-tests and ANOVA's such that effect sizes can be used in a-priori power analyses and meta-analyses. Whereas many articles about effect sizes focus on between-subjects designs and address within-subjects designs only briefly, I provide a detailed overview of the similarities and differences between within- and between-subjects designs. I suggest that some research questions in experimental psychology examine inherently intra-individual effects, which makes effect sizes that incorporate the correlation between measures the best summary of the results. Finally, a supplementary spreadsheet is provided to make it as easy as possible for researchers to incorporate effect size calculations into their workflow.
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              Development and validation of brief measures of positive and negative affect: the PANAS scales.

              D Watson, L A Clark, A Tellegen (1988)
              In recent studies of the structure of affect, positive and negative affect have consistently emerged as two dominant and relatively independent dimensions. A number of mood scales have been created to measure these factors; however, many existing measures are inadequate, showing low reliability or poor convergent or discriminant validity. To fill the need for reliable and valid Positive Affect and Negative Affect scales that are also brief and easy to administer, we developed two 10-item mood scales that comprise the Positive and Negative Affect Schedule (PANAS). The scales are shown to be highly internally consistent, largely uncorrelated, and stable at appropriate levels over a 2-month time period. Normative data and factorial and external evidence of convergent and discriminant validity for the scales are also presented.
              Article 0 comments Cited 642 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Joshua F Wiley:
                ORCID: https://orcid.org/0000-0002-0271-6702
                School of Psychological Sciences and Turner Institute for Brain and Mental HealthMonash University18 Innovation Walk Monash UniversityMelbourne, 3800Australia61 3 9905 9598joshua.wiley@monash.edu
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: July 2022
                Publication date (Electronic): 27 July 2022
                Volume: 11
                Issue: 7
                Electronic Location Identifier: e36658
                Affiliations
                [1 ] School of Psychological Sciences and Turner Institute for Brain and Mental Health Monash University Melbourne Australia
                [2 ] Biostatistics Center Massachusetts General Hospital Boston, MA United States
                [3 ] Department of Psychiatry College of Medicine University of Arizona Tucson, AZ United States
                [4 ] Peter MacCallum Cancer Centre Melbourne Australia
                Author notes
                Corresponding Author: Joshua F Wiley joshua.wiley@ 123456monash.edu
                Author information
                https://orcid.org/0000-0001-7395-1358
                https://orcid.org/0000-0001-8351-4231
                https://orcid.org/0000-0001-7642-7025
                https://orcid.org/0000-0002-0422-6651
                https://orcid.org/0000-0001-5985-8560
                https://orcid.org/0000-0001-9660-6573
                https://orcid.org/0000-0002-0271-6702
                Article
                Publisher ID: v11i7e36658
                DOI: 10.2196/36658
                PMC ID: 9377468
                PubMed ID: 35896021
                SO-VID: 812feb7a-71c8-4d75-b7e5-7b12b1f5fa0c
                Copyright © ©Isabelle S Smith, Rebecca Wallace, Cornelia Wellecke, Marie-Abèle Bind, Karen L Weihs, Bei Bei, Joshua F Wiley. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.07.2022.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 6 February 2022
                Date revision requested : 21 June 2022
                Date revision received : 26 June 2022
                Date accepted : 27 June 2022
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: cancer survivor,depressive symptoms,anxiety symptoms,emotion regulation,unified protocol,transdiagnostic,internet-delivered intervention,quality of life,ehealth,randomized controlled trial,psycho-oncology,mobile phone
                Data availability:
                Keywords: cancer survivor, depressive symptoms, anxiety symptoms, emotion regulation, unified protocol, transdiagnostic, internet-delivered intervention, quality of life, ehealth, randomized controlled trial, psycho-oncology, mobile phone

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