Study protocol for a feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Introduction

A subgroup of parents of children previously treated for cancer report long-term psychological distress after end of treatment. However, needs for psychological support are commonly unmet and there is a lack of evidence-based treatments tailored to the specific needs of this population. An internet-administered, guided, cognitive–behavioural therapy-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer may provide a solution. The aim is to examine the feasibility and acceptability of the intervention ENGAGE and the study procedures for a future controlled trial.

Methods and analysis

The study has an uncontrolled within-group design with an embedded qualitative and quantitative process evaluation. Potential participants are parents of children previously treated for cancer, living in Sweden, recruited via their child’s personal identification number (via the Swedish Childhood Cancer Registry and the Swedish Tax Agency). Parents are invited randomly with information packs sent to home addresses. Further interest in participating can be registered via information on relevant websites. The study aims to recruit 50 parents who will receive the intervention ENGAGE which is designed to be delivered over a 10-week period, and comprises one introductory chapter followed by up to 10 intervention modules addressing key concerns identified for the population. Consistent with feasibility study objectives, primary outcomes relate to recruitment, attrition, data collection, study resources, intervention delivery and acceptability. Clinical outcomes (post-traumatic stress, depression, anxiety, fear of cancer recurrence, psychological inflexibility and experiential avoidance, depressed inactivity, fatigue, quality of life and self-compassion) will be measured at baseline, post-treatment (12 weeks) and 6-month follow-up.

Ethics and dissemination

The Regional Ethical Review Board in Uppsala, Sweden has granted approval for the study (Dnr: 2017/527). Results will be disseminated to relevant healthcare and patient communities, in peer-reviewed and popular science journals, and at scientific and clinical conferences.

Trial registration number

ISRCTN57233429; Pre-results.

Related collections

Most cited references 33

Record: found
Abstract: found
Article: not found

Construction and factorial validation of a short form of the Self-Compassion Scale.

Filip Raes, Elizabeth Pommier, Kristin Neff … (2011)

The objective of the present study was to construct and validate a short-form version of the Self-Compassion Scale (SCS). Two Dutch samples were used to construct and cross-validate the factorial structure of a 12-item Self-Compassion Scale-Short Form (SCS-SF). The SCS-SF was then validated in a third, English sample. The SCS-SF demonstrated adequate internal consistency (Cronbach's alpha ≥ 0.86 in all samples) and a near-perfect correlation with the long form SCS (r ≥ 0.97 all samples). Confirmatory factor analysis on the SCS-SF supported the same six-factor structure as found in the long form, as well as a single higher-order factor of self-compassion. The SCS-SF thus represents a reliable and valid alternative to the long-form SCS, especially when looking at overall self-compassion scores. Copyright © 2010 John Wiley & Sons, Ltd.

0 comments Cited 696 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

Sandra M. Eldridge, Gillian A. Lancaster, Michael J Campbell … (2016)

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

0 comments Cited 446 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P)

Clazien AM Bouwmans, Kim de Jong, Reinier Timman … (2013)

Background Patient self-report allows collecting comprehensive data for the purpose of performing economic evaluations. The aim of the current study was to assess the feasibility, reliability and a part of the construct validity of a commonly applied questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder (TiC-P). Methods Data were derived alongside two clinical trials performed in the Netherlands in patients with mental health problems. The response rate, average time of filling out the questionnaire and proportions of missing values were used as indicators of feasibility of the questionnaire. Test-retest analyses were performed including Cohen’s kappa and intra class correlation coefficients to assess reliability of the data. The construct validity was assessed by comparing patient reported data on contacts with psychotherapists and reported data on long-term absence from work with data derived from registries. Results The response rate was 72%. The mean time needed for filling out the first TiC-P was 9.4 minutes. The time needed for filling out the questionnaire was 2.3 minutes less for follow up measurements. Proportions of missing values were limited (< 2.4%) except for medication for which in 10% of the cases costs could not be calculated. Cohen’s kappa was satisfactory to almost perfect for most items related to healthcare consumption and satisfactory for items on absence from work and presenteeism. Comparable results were shown by the ICCs on variables measuring volumes of medical consumption and productivity losses indicating good reliability of the questionnaire. Absolute agreement between patient-reported data and data derived from medical registrations of the psychotherapists was satisfactory. Accepting a margin of +/− seven days, the agreement on reported and registered data on long-term absence from work was satisfactory. The validity of self-reported data using the TiC-P is promising. Conclusions The results indicate that the TiC-P is a feasible and reliable instrument for collecting data on medical consumption and productivity losses in patients with mild to moderate mental health problems. Additionally, the construct validity of questions related to contacts with psychotherapist and long-term absence from work was satisfactory.

0 comments Cited 186 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2018

Publication date (Electronic): 14 June 2018

Volume: 8

Issue: 6

Electronic Location Identifier: e023708

Affiliations

[1 ]departmentClinical Psychology in Healthcare, Department of Women’s and Children’s Health , Uppsala University , Uppsala, Sweden

[2 ]departmentPaediatric Oncology, Department of Women’s and Children’s Health , Uppsala University , Uppsala, Sweden

Author notes

[Correspondence to ] Dr Joanne Woodford; joanne.woodford@ 123456kbh.uu.se

Article

Publisher ID: bmjopen-2018-023708

DOI: 10.1136/bmjopen-2018-023708

PMC ID: 6009624

PubMed ID: 29903802

SO-VID: 54b92ef9-9adc-407c-a408-a066c860ab9c

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 19 April 2018

Date revision received : 03 May 2018

Date accepted : 04 May 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004359, Vetenskapsrådet;

Funded by: FundRef http://dx.doi.org/10.13039/501100002794, Cancerfonden;

Funded by: FundRef http://dx.doi.org/10.13039/501100006313, Barncancerfonden;

Custom metadata

special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: parents,ehealth,depression,anxiety,clinical trial

Data availability:

ScienceOpen disciplines: Medicine

Keywords: parents, ehealth, depression, anxiety, clinical trial

Comments

Comment on this article

scite_

Cited by 12

See all cited by

Most referenced authors 976

See all reference authors

Study protocol for a feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer

Read this article at

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Drug Repurposing

Most cited references 33

Construction and factorial validation of a short form of the Self-Compassion Scale.

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P)

Author and article information

Journal

Affiliations

Author notes

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 70

Cited by 12

Most referenced authors 976