Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).

BACKGROUND: Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence-based psychological interventions for parents, with psychological support needs unmet. An internet-administered, guided, low-intensity cognitive behavioral therapy-based (LICBT) self-help intervention may provide a solution. METHODS: The feasibility and acceptability of such an intervention was examined using a single-arm feasibility trial (ENGAGE). Primary objectives examined: (1) estimates of recruitment and retention rates; (2) feasibility and acceptability of data collection instruments and procedures; and (3) intervention feasibility and acceptability. Clinical outcomes were collected at baseline, post-treatment (12 weeks), and follow-up (6 months). RESULTS: The following progression criteria were met: sample size was exceeded within 5 months, with 11.0% enrolled of total population invited, study dropout rate was 24.0%, intervention dropout was 23.6%, missing data remained at ≤10% per measure, and no substantial negative consequences related to participation were reported. Intervention adherence was slightly lower than progression criteria (47.9%). CONCLUSION: Findings suggest an internet-administered, guided, LICBT self-help intervention may represent a feasible and acceptable solution for parents of children treated for cancer. With minor study protocol and intervention modifications, progression to a pilot randomized controlled trial (RCT) and subsequent superiority RCT is warranted.

Concerns experienced by parents of children treated for cancer: A qualitative study to inform adaptations to an internet-administered, low-intensity cognitive behavioral therapy intervention.

OBJECTIVE: Childhood cancer treatment completion is associated with mental health difficulties and negative socioeconomic consequences for parents. However, psychological support needs are often unmet. We developed an internet-administered, guided, low-intensity cognitive behavioral therapy-based self-help intervention (EJDeR) and examined feasibility and acceptability with a single-arm feasibility trial (ENGAGE). Results suggest EJDeR is acceptable, however, adherence, especially for fathers, could be improved. Following the Medical Research Council complex interventions framework, this study explores concerns experienced by parents actively seeking support related to their child's cancer who were recruited into ENGAGE to inform further adaptation of EJDeR. METHOD: Seventy-three semi-structured interviews (26 fathers, 47 mothers) were conducted, with data analyzed using manifest content analysis. RESULTS: Analysis resulted in seven categories: (1) Feeling lost and lonely in life; (2) Low mood; (3) Parenting difficulties; (4) Productivity difficulties; (5) Relationship challenges; (6) Stress reactions; and (7) Worry. With the exception of subcategories Afraid of not being a good parent, Cancer recurrence, and Child's development and future a somewhat higher percentage of mothers than fathers mentioned all identified concerns. CONCLUSION: Parents described experiencing a range of concerns after their child had completed cancer treatment. EJDeR will be adapted to address these concerns and include indirect intervention modules targeting concerns such as stress. Information to support parenting, relationships, finance, and employment difficulties, alongside signposting to inform help-seeking, will be included. Findings also suggest a need to improve the gender-sensitivity of EJDeR.

The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial.

BACKGROUND: Recruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates. METHODS: We undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression. RESULTS: Of the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68-2.06). No statistically significant differences were found for any secondary outcome. CONCLUSIONS: Personalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted. TRIAL REGISTRATION: ISRCTN57233429 ; ISRCTN18404129 ; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) ( https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf ).