Testing a workbook and audio-delivered self-help programme with telephone support from a parent guide for parents of persons treated for cancer during childhood
| ISRCTN | ISRCTN51549508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51549508 |
| Sponsor | Uppsala University |
| Funders | Barncancerfonden, Cancerfonden, Vetenskapsrådet |
- Submission date
- 27/02/2026
- Registration date
- 06/03/2026
- Last edited
- 06/03/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A child's cancer diagnosis affects not only the child but the entire family. The child's parents can experience psychological distress long after the child's treatment has ended. Despite this, few parents receive psychological support. This can lead to additional psychological difficulties and costs for the family as well as for society.
Together with parents of persons treated for cancer during childhood, our research team has developed the self-help programme EJDeR. The programme is based on low-intensity cognitive behavioral therapy and is delivered via workbooks, audio files, and video case vignettes, and includes telephone support from a parent guide. The goal of the programme is to improve parents' psychological well-being.
In a previous study, we tested the feasibility of an internet-delivered version of EJDeR. The results showed that parts of the programme’s content, as well as the way it was delivered, should be adapted to better meet parents' needs. Based on these results, we have made adaptations to the programme, e.g., the programme is now delivered via workbooks and audio files rather than the internet. The current version of the programme and planned procedures for a controlled evaluation of the programme are tested in this study.
Who can participate?
Parents of a person diagnosed with cancer at the age of 0–18 years whose treatment was completed 3 months to 5 years earlier, who understand, speak, read, and write Swedish well enough to access the study material, provide informed consent, answer questionnaires, participate in interviews, and work with EJDeR, and who have a mobile phone with a telephone number.
What does the study involve?
If a participant consents to study participation and meets the above criteria for participating, they are randomly allocated to one of two groups. One group gets access to EJDeR and the other group does not get access to EJDeR. Participants who get access to EJDeR work with the programme for 12 weeks. Everyone who participates in the study can still use the care they already have access to, such as psychological support or prescribed medication via primary care. 12 weeks after being randomly allocated to one of the groups, as well as six months after that, all participants are asked to answer questions via the telephone about their well-being, health, and work life. Participants who get access to EJDeR are asked to participate in an interview about EJDeR 12 weeks after being randomly allocated to EJDeR.
What are the possible benefits and risks of participating?
Being randomly allocated to the group that gets access to EJDeR and working with EJDeR may help participants feel better. Participating in the study involves setting aside time to answer questions. Answering questions about well-being provides all participants with their opportunity to reflect on their well-being, which may be helpful but may also trigger difficult feelings and memories. We are not expecting any serious risks from participating in the study, but if at any time during the study parents report levels of distress that require more intensive support, we direct parents to appropriate mental health services.
Where is the study run from?
Uppsala University (Sweden)
When is the study starting and how long is it expected to run for?
April 2026 to April 2027
Who is funding the study?
The study is funded by the Swedish Research Council, the Swedish Cancer Society, and the Swedish Childhood Cancer Fund
Who is the main contact?
Louise von Essen, louise-von.essen@uu.se
Contact information
Principal investigator, Scientific, Public
MTC-huset, Dag Hammarskjölds väg 14B, 1 tr
Uppsala
752 37
Sweden
 ORCID ID |
0000-0001-5816-7231 |
|---|---|
| Phone | +46 (0)70-425 07 14 |
| louise-von.essen@uu.se |
Scientific
MTC-huset, Dag Hammarskjölds väg 14B, 1 tr
Uppsala
752 37
Sweden
| ORCID ID |
0000-0001-5062-6798 |
|---|---|
| Phone | +46 (0)70-787 46 84 |
| joanne.woodford@uu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A workbook and audio-administered, telephone guided, low-intensity cognitive behavioral therapy intervention plus usual care versus usual care alone for improving mental well-being in parents of persons treated for cancer during childhood: pilot randomized controlled trial and embedded mixed methods process evaluation (CHANGE-pilot) |
| Study acronym | CHANGE-pilot |
| Study objectives | The objectives are to examine the feasibility of: 1. EJDeR delivered via workbooks, audio files, and video vignettes with telephone guidance from a parent guide 2. Planned study procedures for a future evaluation of EJDeR 3. Possible relationships between how EJDeR is delivered, how study participants work with EJDeR, study participants’ experience of how EJDeR works, contextual factors, and variation in mental well-being and symptoms of depression, anxiety, and post-traumatic stress (PTSS) Research questions: Procedural uncertainties: 1. Is there a difference in sociodemographic characteristics between those invited versus those who consent? 2. What proportion of those invited consent, are assessed for inclusion, are included, and are randomized? 3. What proportion of the intervention and control groups complete questionnaires at baseline, post-treatment, and follow-up? 4. What proportion of responses are missing in each questionnaire for the intervention and control group at baseline, post-treatment, and follow-up? Intervention uncertainties: 5. What proportion of the intervention group completes the minimum treatment dose? Methodological uncertainties: 6. What is the variance in mental well-being for the intervention and control groups at post-treatment and follow-up, and is there a correlation with mental well-being at baseline? 7. Is there a difference in mental well-being between the intervention and control groups at post-treatment and follow-up? Implementation: 8. To what extent do parent guides follow the protocols for EJDeR? 9. To what extent is the intervention group working with EJDeR as intended? Mechanisms of impact: 10. What potential mechanisms of impact does the intervention group experience with EJDeR, and do they experience a relationship between these and the outcomes of EJDeR? Context: 11. Are contextual factors related to the intervention group’s mental well-being and symptoms at post-treatment? If yes, how? 12. Does the intervention group experience barriers or facilitators when working with EJDeR? If yes, which ones? |
| Ethics approval(s) |
Approved 02/02/2026, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 2025-09024-01 |
| Health condition(s) or problem(s) studied | Mental well-being among parents of persons treated for cancer during childhood |
| Intervention | Inclusion interview: Potential participants are asked questions via telephone to confirm eligibility. If a person is included, they are asked questions about their sociodemographic characteristics and their child’s sociodemographic characteristics and medical data (≈15 minutes). Baseline assessments: Clinical outcomes, health economic outcomes, and process outcomes are collected for all participants via telephone (≈30 minutes). Randomization: After completing the baseline assessment, participants are randomly allocated to the intervention (EJDeR plus usual care) or control group (usual care alone) in a 1:1 ratio using block randomization (block size of 6). Randomization is conducted through an online software application (https://www.sealedenvelope.com/) by an individual external to the research team. Intervention content: EJDeR is a workbook and audio-administered, telephone-guided low-intensity cognitive behavioral therapy (LICBT) intervention tailored to parents of persons treated for cancer during childhood delivered over 12 weeks. Workbooks include text, exercises, illustrations, and written parent case vignettes. Audio recordings of workbook text, including exercise instructions, and videos of parent case vignettes (video case vignettes), are provided via an online platform. The LICBT techniques are worry time and problem-solving. EJDeR is guided by a parent guide with documented advanced CBT skills. Participants randomly assigned to EJDeR can access usual care (see below). Usual care: Participants allocated to the control group continue with usual care, which may include (1) psychological support in accordance with national guidelines for treatment of anxiety and depression and (2) prescribed psychotropic drugs via primary care. Participants allocated to the control group will not be offered EJDeR at the end of the trial. Post-treatment assessments: Clinical outcomes, health economic outcomes, and process outcomes are collected for all participants via telephone (≈30 minutes) 12 weeks after randomization. The intervention group also answers questions about their experience with EJDeR and the parent guide (≈5 minutes) and participate in a semistructured interview (≈45 minutes). Follow-up assessments: Clinical outcomes, health economic outcomes, and process outcomes are collected for all participants via telephone (≈30 minutes) 6 months after post-treatment assessments. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 26/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Be a parent of a person diagnosed with cancer at the age of 0–18 years whose treatment was completed 3 months to 5 years earlier 2. Understand, speak, read, and write Swedish well enough to access the study material, provide informed consent, answer questionnaires, participate in interviews, and work with EJDeR 3. Have a mobile phone with a telephone number |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 27/04/2026 |
| Date of final enrolment | 27/07/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (Zenodo: https://zenodo.org/). Anonymized quantitative data is deposited in public data repositories (Zenodo). Participants are informed of the data-sharing plans in the participant information sheet and provide informed consent accordingly. Before sharing, all personal identifiers are removed or coded to ensure individual participants cannot be identified. Metadata will be registered in the Swedish National Data Service (SND) catalogue, in accordance with national recommendations from the Swedish Research Council (Vetenskapsrådet), to ensure discoverability through SwePub/SND. |
Editorial Notes
27/02/2026: Study's existence confirmed by the Swedish Ethical Review Authority.
