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Clinical trials are often challenged with issues of recruitment and retention. Little is known concerning general attitudes and preferences toward trial design and willingness to participate among parents of children treated for cancer. Furthermore, willingness to participate in internet-administered psychological interventions remains unexplored. In this study, we examined attitudes and preferences of the population regarding study procedures for a hypothetical trial of an internet-administered psychological intervention. In addition, differences in the response rate between modes of study invitation and willingness to engage in internet-administered interventions were examined.
The primary objective of this study was to examine attitudes and preferences toward participating in an internet-administrated psychological intervention. The secondary objective was to examine the response rates and help-seeking behavior among parents of children treated for cancer.
A cross-sectional, Web-based survey was conducted with parents of children who had completed cancer treatment. This Web-based survey examined self-reported emotional distress, prior help-seeking and receipt of psychological support, past research participation, attitudes toward research, preferences concerning recruitment procedures, and attitudes toward different types of trial design.
Of all the parents invited, 32.0% (112/350) completed the survey, with no difference in response rate between modes of study invitation (χ21=0.6,
Parents of children treated for cancer appear willing to participate in trials examining internet-administered psychological support. Findings of this study will inform the design of a feasibility trial examining internet-administered psychological support for the population.
Due to marked treatment advances across the developed world, the overall 5-year survival rate of children diagnosed with cancer is now >80% [
Electronic mental health interventions (eMental Health) may represent a way of increasing access to psychological support [
This study builds upon the previous MRC phase I development [
The primary study aims were to examine (1) attitudes and preferences toward trial design and (2) willingness to participate in a hypothetical trial of internet-administered psychological intervention for parents of children treated for cancer. Secondary study aims were to investigate (1) overall response rates and differences in the response rate between two modes of study invitation and (2) current and past emotional distress and help-seeking behavior. The following outcomes were examined:
Overall response rate
Number of study invitation reminders required to recruit
Differences in the response rate between two modes of study invitation (standard letter and professionally illustrated postcard)
Self-reported current and past emotional distress
Prior help-seeking and receipt of psychological support
Willingness to receive internet-administered psychological support
Past experience of research participation and attitudes toward research
Attitudes and preferences concerning the delivery of initial study invitations and presentation of full study information
Attitudes toward participation in different trial designs (waiting list control, alternative active treatment, and patient-preference).
A cross-sectional, Web-based, self-report survey was conducted from April 2017 to June 2017 with parents of children treated for cancer and recruited across Sweden.
In this survey study, Swedish-speaking parents of children treated for cancer (aged 0-16 years at study commencement) residing in Sweden were eligible. Parents were included if the child had (1) completed successful cancer treatment 3 months to 5 years earlier at study commencement and (2) been treated in 1 of the 6 pediatric oncology units in Sweden. Parents were excluded if the child had a benign tumor.
Potential participants were identified using a two-step screening process:
Childhood cancer survivors, meeting the inclusion criteria, were identified via the Swedish Childhood Cancer Registry (National Quality Registry, initiated in 1982).
Children’s personal identification numbers were linked to parents’ personal identification numbers via the SPAR-Registry (“Statens personadressregister” by Swedish acronym) held by the Swedish Tax Agency to obtain parent contact information.
Although the SPAR-Registry includes all currently registered residents in Sweden, at the time of the study, it was only possible to access parent information for children aged ≤16 years. Therefore, the current age-span of children, whereby it was possible to identify parents, was restricted to 0-16 years.
From identified parents, an in-house computer program was used to randomize to the mode of invitation (letter vs postcard), with a 1:1 allocation, stratified by cohabitation status (cohabiting parents, noncohabiting parents, one parent registered). Prior to posting invitations, the most up-to-date information concerning whether children were currently living, or deceased, was checked via the telephone by a member of the research group with the Swedish Tax Agency.
Parents were sent an invitation either via a postcard (
Study invitation postcard.
Study invitation letter.
Parents were provided full study information via the U-CARE-portal (
Ethical approval was obtained from the Regional Ethical Review Board in Uppsala (DNR: 2015/426/3).
Sample size calculation indicated that a minimum of 340 participants would be required to detect a difference of 15% in the response rate between groups (ie, those who responded vs those who did not respond), with a power of 0.8 and
The following sociodemographic data were collected for parents via the SPAR-Registry: (1) date of birth; (2) gender; and (3) marital status. Sociodemographic data for children were collected via the Swedish Childhood Cancer Registry: (1) cancer diagnosis; (2) date of diagnosis; (3) date of treatment completion; (4) date of birth; and (5) gender.
A Web-based survey, consisting of 20 items and written in Swedish, was designed for the study and comprised 4 subsections as follows: (1) sociodemographics (3 items); (2) emotional distress and psychological support (6 items); (3) experience of participation in research and attitudes toward research (2 items); and (4) attitudes toward proposed trial procedures (9 items). The survey was administered on the U-CARE-portal, an internet research platform, designed to support both data collection and the provision of complex eMental Health interventions [
Study recruitment and flow are reported using an adapted version of the Consolidated Standards of Reporting Trials Statement [
The majority of parents who responded were female, cohabiting, with a mean age of 43.2 years. Children were predominantly male, had experienced leukemia, with a mean current age of 9.3 years, and had finished cancer treatment an average of 2.9 years ago. No significant differences were noted regarding parent or child sociodemographic and clinical variables between those who responded and those who did not (
Study recruitment and flow.
Baseline characteristics of those who responded versus those who did not respond (N=350).
Characteristics | Parents who responded (n=112) | Parents who did not respond (n=238) | ||||
.13 | ||||||
Female | 63 (56.3) | 113 (47.5) | ||||
Male | 49 (43.7) | 125 (52.5) | ||||
.75 | ||||||
Cohabiting | 90 (80.4) | 196 (82.4) | ||||
Living apart | 20 (17.8) | 36 (15.1) | ||||
Unknown | 2 (1.8) | 6 (2.5) | ||||
Age in years, mean (SD) | 43.2 (7.3) | 43.1 (6.6) | .87 | |||
.73 | ||||||
Female | 51 (45.5) | 113 (47.5) | ||||
Male | 61 (54.5) | 125 (52.5) | ||||
.55 | ||||||
Leukemia | 76 (67.9) | 156 (65.5) | ||||
Central nervous system tumor | 22 (19.6) | 58 (24.4) | ||||
Solid tumor | 14 (12.5) | 24 (10.1) | ||||
Age in years, mean (SD) | 9.3 (2.8) | 10.0 (3.0) | .63 | |||
Years since end of treatment, mean (SD) | 2.9 (1.4) | 2.9 (1.4) | .43 |
No difference was noted between the mode of invitation and response rate (letter: 59/112, 52.7%, vs postcard: 53/112, 47.3%; (χ21=0.6,
Almost half of the parents had previously participated in research, and the majority responded that they held either very high or somewhat high trust in research (
The majority of parents responded that they would either accept, or maybe accept, participation in a hypothetical RCT of an internet-administered psychological intervention utilizing a waiting list control condition. Little difference in the preference was found regarding an acceptable length of waiting list time; however, a slightly higher acceptance was reported for a waiting list length of 1-2 months (see
Emotional distress and preferences for psychological support (n=112).
Emotional distress and preferences | Value, n (%) | ||
Yes | 41 (36.6) | ||
No | 70 (62.5) | ||
Missing | 1 (0.9) | ||
Yes | 80 (71.4) | ||
No | 32 (28.6) | ||
Yes | 48 (42.8) | ||
No | 33 (29.5) | ||
Not applicable (no past or current emotional distress) | 31 (27.7) | ||
Yes | 39 (81.2) | ||
No | 8 (16.7) | ||
Missing | 1 (2.1) | ||
Psychologist | 14 (29.2) | ||
Therapist | 13 (27.1) | ||
Physician | 12 (25.0) | ||
Counselor | 7 (14.6) | ||
Health care center | 6 (12.5) | ||
Church | 2 (4.2) | ||
Stress management self-help program | 1 (2.1) | ||
Mindfulness Exercises | 1 (2.1) | ||
Other (unspecified) | 13 (31.7) | ||
Internet-administered psychological treatment with support from a psychologist | 11 (26.8) | ||
Internet-administered psychological treatment and to see a psychologist in person | 11 (26.8) | ||
Internet-administered psychological treatment without support from a psychologist | 3 (7.3) | ||
See a psychologist in person | 2 (5.0) | ||
Missing | 1 (2.4) | ||
Yes | 47 (42.0) | ||
Maybe | 36 (32.1) | ||
No | 28 (25.0) | ||
Missing | 1 (0.9) |
an=48.
bMultiple responses possible.
cOpen-ended question.
dn=41.
Past experience of research participation and attitudes toward research (n=112).
Experience with and attitude toward research | Value, n (%) | |
No | 56 (50.0) | |
Yes | 55 (49.1) | |
Missing | 1 (0.9) | |
Very high | 56 (50.0) | |
Somewhat high | 51 (45.5) | |
Moderate | 5 (4.5) |
Attitudes concerning trial procedures (n=112).
Attitude | Value, n (%) | |||
Postal letter | 86 (76.8) | |||
Meeting with a physician, psychologist, or nurse | 34 (30.4) | |||
Telephone | 18 (16.1) | |||
Short message service text message | 13 (11.6) | |||
Other | 11 (9.8) | |||
Text | 81 (72.3) | |||
Video | 66 (58.9) | |||
Image(s) | 43 (38.4) | |||
Audio | 23 (20.5) | |||
Researcher | 84 (75.0) | |||
Psychologist | 44 (39.3) | |||
Nurse previously met | 43 (38.4) | |||
Parent of a child treated for cancer | 36 (32.1) | |||
Psychologist previously met | 32 (28.6) | |||
Nurse | 30 (26.8) | |||
Another option, not specified | 11 (9.8) | |||
Yes | 53 (47.3) | |||
Maybe | 41 (36.6) | |||
No | 18 (16.1) | |||
1-2 months | 20 (17.8) | |||
3-4 months | 15 (13.4) | |||
5-6 months | 17 (15.2) | |||
>6 months | 18 (16.1) | |||
Other | 11 (9.8) | |||
Would decline participation | 17 (15.2) | |||
Missing | 14 (12.5) | |||
Yes | 49 (43.7) | |||
Maybe | 42 (37.5) | |||
No | 18 (16.1) | |||
Missing | 3 (2.7) | |||
Yes | 59 (52.7) | |||
Maybe | 34 (30.3) | |||
No | 17 (15.2) | |||
Missing | 2 (1.8) |
aParticipants could select multiple options.
This cross-sectional, Web-based survey examined attitudes and preferences toward and willingness to participate in a hypothetical trial of an internet-administered psychological intervention for parents of children treated for cancer. Furthermore, differences in the response rate between two modes of study invitation (standard letter vs professionally illustrated postcard) were examined. To the best of our knowledge, this is the first survey to examine attitudes and preferences toward the design of and participation in internet-administered psychological intervention trials within the population. Summarizing the main findings, an overall 32.0% (112/350) response rate was yielded, yet no difference was found in the response rate between modes of study invitation. Self-reported current and past emotional distress was common. Internet-administered psychological support, under guidance of a psychologist, was deemed acceptable by the majority of those parents currently reporting emotional distress and of the surveyed population as a whole. Examination of acceptable recruitment methods indicated the most acceptable method of study invitation would be via postal letter, with full study information presented on a study website via text or video and delivered by a researcher. On the whole, parents responded that they would either accept, or maybe accept, participation in each presented hypothetical trial design (waiting list control, alternative active treatment, patient-preference), with no overall indication of a preferred trial design.
It is interesting to note that no association between the mode of invitation and the response rate was detected. As such, this suggests professional illustration may not increase study response rates. This finding is in contrast to research indicating that professionally designed invitation packs can improve recruitment rates [
Another noteworthy finding was that parents showed an overall preference for receiving initial study invitations via the post. While postal recruitment from disease registers is a common recruitment strategy [
Interestingly, similar percentages of parents responded they would agree, or maybe agree, to participate in trials using waiting list control, alternative active treatment, and patient-preference designs. Furthermore, little difference was found concerning acceptable waiting times for a hypothetical waiting list RCT. As such, the majority responded they would be willing to participate in hypothetical trial designs utilizing randomization procedures. This finding is in contrast to research reporting that a fear of randomization is a common reason for declining trial participation [
In line with previous research [
This study has several limitations. First, willingness to participate in a hypothetical trial of an internet-administered psychological intervention may not predict actual trial enrollment [
Another limitation pertains to only examining the acceptability of more traditional clinical trial recruitment strategies, for example, postal recruitment and clinician referral. However, evidence suggests Web-based recruitment strategies are effective for internet-administered intervention trials [
Notwithstanding these limitations, this is to our knowledge the first study to examine attitudes toward clinical trials, preferences regarding study design, and willingness to receive internet-administered psychological support among parents of children previously treated for cancer. The results from this study will have considerable implications for the design of a planned feasibility study [
Clinical trial conduct is time and resource intensive. While research has been performed to examine attitudes and preferences toward clinical trial design and participation [
Postcard and letter invitation text (English translation).
Full study information (English translation).
Informed consent (English translation).
Informational video (Swedish).
Informational video (English transcript).
Informational video PowerPoint slide (English translation).
Web-based survey (English translation).
internet-administered cognitive behavioral therapy
Medical Research Council
randomized controlled trial
We would like to thank Associate Professor Gustaf Ljungman, MD and Laura Kukkola, MSc, for their valuable contributions and collaboration during the undertaking of this study. We also thank Josefin Hagström, MSc, for reviewing and commenting on a draft of the manuscript. This work was supported by funding to coauthor LvE from The Swedish Research Council (grant number K2015-99X-20836-08-4) and the Swedish Cancer Society (140790). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
None declared.