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Trial registered on ANZCTR


Registration number
ACTRN12617001447347
Ethics application status
Approved
Date submitted
6/10/2017
Date registered
12/10/2017
Date last updated
12/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
e-TC 2.0 - Further development and pilot testing of an online psychological intervention aimed at reducing anxiety, depression and fear of cancer recurrence in testicular cancer survivors
Scientific title
e-TC 2.0 - Further development and pilot testing of an online psychological intervention aimed at reducing anxiety, depression and fear of cancer recurrence in testicular cancer survivors
Secondary ID [1] 293081 0
None
Universal Trial Number (UTN)
U1111-1203-3020
Trial acronym
e-TC (e-Testicular Cancer)
Linked study record
Heiniger LE, Smith AB, Olver I, et al. e-TC: Development and pilot testing of a web-based intervention to reduce anxiety and depression in survivors of testicular cancer. Eur J Cancer Care. 2017;00:e12698. https://doi.org/10.1111/ecc.12698

Health condition
Health condition(s) or problem(s) studied:
Testicular cancer
 305014 0
Distress 305018 0
Anxiety 305024 0
Depression 305025 0
Fear of cancer recurrence 305026 0
Condition category
Condition code
Cancer 304333 304333 0 0
Testicular
Mental Health 304340 304340 0 0
Anxiety
Mental Health 304341 304341 0 0
Depression
Mental Health 304342 304342 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
e-TC 2.0 is comprised of six interactive modules, including psycho-educational material, short survivor and educational videos, and offline exercises. e-TC 2.0 presents information and exercises tailored according to user-reported relationship status (partnered or unpartnered), side-effect profile and baseline treatment goals, to ensure relevance. Modules were designed to take approximately an hour to complete, depending on level of engagement.

Content and skills taught are detailed below.

Module number: 1
Module name: Foundations: Putting together a toolkit to manage stress and worry
Topics covered: - Normalises reactions to testicular cancer (TC) and its treatment. - Introduces key skills (e.g. mindfulness)
Skills/exercises: - Identifying and challenging unhelpful thoughts. -Mindfulness

Module number: 2
Module name: After treatment: How you feel after treatment for TC
Topics covered: - Emotional impact of TC (e.g. anxiety, depression, fear of cancer recurrence, anger). - Normalises emotional reactions
Skills/exercises: - Acceptance and Commitment Therapy principles of defusion, acceptance and connection. - Revisits mindfulness

Module number: 3
Module name: Changes: Physical changes and side effects
Topics covered: Information about changes and side effects by treatment type: 1. Orchidectomy; 2. chemotherapy/radiotherapy; 3. node dissection and other surgeries
Skills/exercises: - Relaxation techniques. - Introduction to Tai Chi and Qi Gong. - Revisits identifying and challenging thoughts. - Revisits acceptance

Module number: 4
Module name: Being a ‘man’: Masculinity and sexuality
Topics covered: - Effect of TC and its treatment on masculinity and sexuality. - Acknowledges changes and loss. - Dispels myths and stereotypes
Skills/exercises: Revisits identifying and challenging thoughts

Module number: 5
Module name: Significant others: Relationships and communication
Topics covered: - Explores potential impact of TC and its treatment on relationships with current/future partners, family and friends. - Enhancing communication
Skills/exercises: - Listening skills. - Assertive communication

Module number: 6
Module name: Moving forward: Life after TC
Topics covered: Information about survivorship issues (e.g. existential concerns, fear of cancer recurrence, physical health, practical concerns) and practical strategies for managing concerns
Skills/exercises: - Identifying values, - Therapeutic writing, - Detached mindfulness, - Worry postponement, - Problem solving, - Goal setting, -Benefit finding

- Who will deliver the intervention? How will be delivered? The intervention will be delivered individually and on an online basis.

- The number of times the intervention will be delivered and over what period of time? The intervention is accessible any day, any time. The intervention is self-paced, thus, time will vary for each participant. Each module should take approximately 1 hour to complete.

- The intervention will be personalised depending on participant’s relationship status, side effects profile and baseline treatment goals. These elements will be identified through the baseline questionnaires. According to the participants responses (partnered or not), the intervention will show a few different content/resources in the corresponding modules. This is important because the experience of testicular cancer survivors and its impact on social and sexual relationships can be different based on relationship status. The side-effects profile and baseline treatment goals are different for each participant, so the intervention needs to provide them with relevant specific resources accordingly.
Intervention code [1] 299323 0
Lifestyle
Intervention code [2] 299328 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303594 0
Feasibility will be determined by the proportion of men who complete at least two-thirds of e-TC as well as website usage data, which will be obtained via Google analytics. Google analytics reports will provide us page views, average time spent on page, entrances, bounce rate and percentage of exit.
Timepoint [1] 303594 0
Proportion of men who complete at least two-thirds of e-TC will be assessed on a monthly basis to monitor participants' progress. Website usage data will be analysed on a monthly basis as well.
Primary outcome [2] 303598 0
Acceptability will be assessed via quantitative and qualitative feedback. Participants are invited to rate various aspects of each module and the intervention as a whole (e.g., usefulness, helpfulness, ease of use, length). A subset of men will be invited to take part in a qualitative interview to provide further information on their experiences of using e-TC.
Timepoint [2] 303598 0
Acceptability will be assessed after completion of each module (time-point will vary for each participant as they complete it at their own pace) and after completion of the whole intervention (time-point will vary as well).
Secondary outcome [1] 339532 0
Distress will be measured by a thermometer where men indicate their level of distress in the previous week from 0 (no distress) to 10 (high distress) (Roth et al., 1998),
Timepoint [1] 339532 0
Distress will be measured at baseline, 20, 40, 60, 80 and 100% of e-TC completion (time will vary according to participant's self-paced progress).
Secondary outcome [2] 339596 0
Impact that the distress has had on their life will be measured by using a thermometer that ranges from 0 (no impact) to 10 (high impact) (Akizuki et al., 2005).
Timepoint [2] 339596 0
Impact that the distress has had will be measured at baseline, 20, 40, 60, 80 and 100% of e-TC completion (time will vary according to participant's self-paced progress).
Secondary outcome [3] 339597 0
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983). Subscale scores range from 0-21.
Timepoint [3] 339597 0
Anxiety will be measured at baseline, once 50% of e-TC has been completed, post-intervention (immediately after e-TC completion) and at 3-month follow-up after e-TC completion.
Secondary outcome [4] 339598 0
Fear of cancer recurrence will be assessed using the 9-item Fear of Cancer Recurrence Inventory (FCRI) Severity Subscale (Simard & Savard, 2015).
Timepoint [4] 339598 0
Fear of cancer recurrence will be assessed at baseline, post-intervention and 3-month follow-up.
Secondary outcome [5] 339599 0
Unmet needs will be assessed by a modified version of the Cancer Survivors’ Unmet Needs measure (CaSUN). A number of items were omitted, based on the consensus of the expert advisory group as they related to specific needs of a cancer patient currently undergoing treatment (e.g., “I need more accessible hospital parking “, “I need to know that all my doctors talk to each other to coordinate my care”). Thus in the present study the CaSUN presented 28 needs.
Timepoint [5] 339599 0
Unmet needs will be assessed at baseline, post-intervention and 3-month follow-up.
Secondary outcome [6] 339600 0
Testicular Cancer-specific quality of life will be assessed by the 26-item Quality of Life Questionnaire – Testicular Cancer (QLQ-TC26) (Holzner et al., 2013).
Timepoint [6] 339600 0
Testicular Cancer-specific quality of life will be assessed at baseline, post-intervention and 3-month follow-up.
Secondary outcome [7] 339686 0
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983). Subscale scores range from 0-21.
Timepoint [7] 339686 0
Depression will be measured at baseline, once 50% of e-TC has been completed, post-intervention (immediately after e-TC completion) and at 3-month follow-up after e-TC completion.

Eligibility
Key inclusion criteria
• Aged over 18
• Completed active treatment for testicular cancer (i.e., not currently undergoing chemotherapy or radiotherapy, not awaiting surgery)
• Adequate English language skills to provide informed consent
• Currently disease-free.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Men who are still undergoing treatment for testicular cancer and men experiencing recurrent disease are not eligible to participate as we are interested in addressing post-treatment concerns of men previously treated for TC.
• Men who are not proficient in reading and writing English are excluded from participating. The website and associated assessments are largely text-based and we only had sufficient resources to develop the website in English.
• Males aged under 18. It has been found that children and adolescents under the age of 18 affected by testicular cancer face different issues (e.g. disruption to school) to affected adults (Carpentier et al., 2011). We did not have sufficient resources to develop a website that catered for both children/adolescents and adults affected by TC, so initially we plan to evaluate e-TC 2.0 in adults, which is the largest group affected.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single-arm multi-site phase I trial using mixed methods (quantitative and qualitative).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to describe participant characteristics and the acceptability of different components and aspects of e-TC.

A two-sided Fisher’s exact test will be used to determine the feasibility of e-TC (adherence to the intervention).

A repeated-measures t-test will be used to compare HADS and FCRI severity subscale scores at baseline and follow-up time points.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/05/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
40
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 9165 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 9166 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 9167 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 9168 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 9169 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 9170 0
Northern Cancer Institute - St Leonards
Recruitment postcode(s) [1] 17679 0
2050 - Camperdown
Recruitment postcode(s) [2] 17680 0
2139 - Concord
Recruitment postcode(s) [3] 17681 0
3000 - Melbourne
Recruitment postcode(s) [4] 17682 0
3168 - Clayton
Recruitment postcode(s) [5] 17683 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297702 0
Other Collaborative groups
Name [1] 297702 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Country [1] 297702 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Ingham Institute for Applied Medical Research
Address
1 Campbell Street Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 296737 0
None
Name [1] 296737 0
Address [1] 296737 0
Country [1] 296737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298773 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 298773 0
Ethics committee country [1] 298773 0
Australia
Date submitted for ethics approval [1] 298773 0
09/01/2017
Approval date [1] 298773 0
09/02/2017
Ethics approval number [1] 298773 0
HREC/16/RPAH/627

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2099 2099 0 0
/AnzctrAttachments/373783-Approval_20170217.pdf (Ethics approval)

Contacts
Principal investigator
Name 78190 0
Dr Alan 'Ben' Smith
Address 78190 0
Ingham Institute for Applied Medical Research
1 Campbell Street Liverpool NSW 2170
Country 78190 0
Australia
Phone 78190 0
+61 (02) 8738 9244
Fax 78190 0
Email 78190 0
ben.smith@unsw.edu.au
Contact person for public queries
Name 78191 0
Alan 'Ben' Smith
Address 78191 0
Ingham Institute for Applied Medical Research
1 Campbell Street Liverpool NSW 2170
Country 78191 0
Australia
Phone 78191 0
+61 (02) 8738 9244
Fax 78191 0
Email 78191 0
ben.smith@unsw.edu.au
Contact person for scientific queries
Name 78192 0
Alan 'Ben' Smith
Address 78192 0
Ingham Institute for Applied Medical Research
1 Campbell Street Liverpool NSW 2170
Country 78192 0
Australia
Phone 78192 0
+61 (02) 8738 9244
Fax 78192 0
Email 78192 0
ben.smith@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.