ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000001796

Ethics application status

Approved

Date submitted

12/12/2012

Date registered

2/01/2013

Date last updated

11/11/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Finding My Way: A randomised controlled trial of an online self-help coping program for reducing cancer distress.

Scientific title

A randomised controlled trial comparing the efficacy of 'Finding My Way' with an information-control in reducing distress for patients with early stage cancer.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

FMW

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Psychological distress

Condition category

Condition code

Cancer

Any cancer

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

'Finding My Way' (FMW) is a 6-week multimedia internet application, where a new module is released to participants each week, with a reminder email to use the program. The frequency in which participants will access these modules will be at the participants' discretion. Modules cover a range of commonly experienced psychosocial issues. Each module of FMW is comprised of three main components: psycho-education, cognitive-behavioural worksheets / strategies, and survivor stories and quotes. An online journal-blog and a resource section is available throughout the duration of the program.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

An online information-only version of Finding My Way will be simultaneously developed to provide an appropriate attention control for the study. The control condition covers the same 6 module topics, but has no interactive features(i.e., no worksheets, activities, relaxation exercises, or journal-blog).

Control group

Active

Outcomes

Primary outcome [1]

Negative affect: the total scale score of the Depression, Anxiety, Stress Scale.

Timepoint [1]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Primary outcome [2]

Traumatic stress: the total scale score of the Post-Traumatic Stress Scale - Self Report. This scale measures cancer-specific distress.

Timepoint [2]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [1]

Coping: Helplessness Hopelessness as measured by the mini-MAC

Timepoint [1]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [2]

Coping: Anxious Preoccupation as measured by the mini-MAC

Timepoint [2]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [3]

Coping: Cognitive Avoidance as measured by the mini-MAC

Timepoint [3]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [4]

Coping: Fatalism as measured by the mini-MAC

Timepoint [4]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [5]

Coping: Fighting Spirit as measured by the mini-MAC

Timepoint [5]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [6]

Health Related Quality of Life (QOL): Total QOL

as measured by the European Organisation for Research on the Treatment of Cancer (EORTC) Quality of Life Qustionaire Cancer-30 item scale (QLQ-C30).

Timepoint [6]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [7]

QOL: Role functioning, as measured by the EORTC QLQ-C30

Timepoint [7]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [8]

QOL: Physical functioning, as measured by the EORTC QLQ-C30

Timepoint [8]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [9]

QOL: Emotional functioning, as measured by the EORTC QLQ-C30

Timepoint [9]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [10]

QOL: Cognitive functioning, as measured by the EORTC QLQ-C30

Timepoint [10]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Secondary outcome [11]

QOL: Social functioning, as measured by the EORTC QLQ-C30

Timepoint [11]

Pre-treatment, post-treatment, then 3 and 6 months after treatment-completion

Eligibility

Key inclusion criteria

1. Cancer being treated with curative intent (e.g., breast, prostate, colorectal, testicular, lymphomas, haematologic or gynaecologic malignancies)
2. Currently receiving active cancer treatment (surgery, chemotherapy, radiotherapy)
3. Age 18 years or over
4. Sufficient English language literacy
5. Access to the internet (home or work)
6. Provide an active email address and phone number

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

1. Diagnosis of advanced cancer
(While advanced cancer patients will not be targeted for recruitment, this is a population that asks for interventions and may self-refer to the program. Therefore individuals who specifically request to participate will be enrolled, but not included in primary analyses. If a large enough sub-sample self-refers to the program, a sub-analysis will be conducted.)

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation is concealed until interventions are assigned: This process will be automated within the website, therefore it is central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation with stratification: A computer sequence generation algorithm in blocks to either ‘intervention’ or ‘attention control’, and each condition is assigned in random order within the block. The stratification variable is 'gender' - to ensure balance across conditions within gender.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

n/a

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2013

Actual

30/09/2013

Date of last participant enrolment

Anticipated

Actual

17/11/2015

Date of last data collection

Anticipated

Actual

26/06/2016

Sample size

Target

188

Accrual to date

Final

191

Recruitment in Australia

Recruitment state(s)

ACT,QLD,SA,WA,VIC

Recruitment postcode(s) [1]

5042

Recruitment postcode(s) [2]

3181

Recruitment postcode(s) [3]

3002

Recruitment postcode(s) [4]

3050

Recruitment postcode(s) [5]

4001

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

School of Psychology
GPO Box 2100
Adelaide
SA, 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Petrina Kasperski, Executive Officer 
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
email: research.ethics@health.sa.gov.au

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/11/2012

Ethics approval number [1]

1/10/0372

Summary

Brief summary

The internet is increasingly utilised by people with cancer to obtain information and support. However, to date no randomised controlled study has evaluated the effectiveness of a structured online self-help therapeutic program. Therefore, the present study aims to examine how helpful 'Finding My Way' is, an interactive online 6-week self-help coping program, compared to receiving online information only, in improving distress, coping and quality of life after cancer diagnosis.

Trial website

www.findingmyway.org.au

Trial related presentations / publications

TRIAL-RELATED PUBLICATIONS
1. Beatty, L., Koczwara, B., & Wade, T. (2011). ‘Cancer Coping Online’: A pilot trial of a self-guided CBT internet intervention for cancer-related distress. Electronic Journal of Applied Psychology, 7, 17-25.
2. Beatty, L., Kemp, E., Wade, T., & Koczwara, B. (2015). Finding My Way: protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress. BMC Cancer, 15, 328. DOI: 10.1186/s12885-015-1322-x.
3. Beatty, L., Koczwara, B., & Wade, T. (2016). Evaluating the efficacy of a self-guided web-based CBT intervention for reducing cancer-distress: A pilot randomised controlled trial. Journal of Supportive Care in Cancer, 24, 1043-1051. DOI: 10.1007/s00520-015-2867-6. 
4. Beatty, L., Kemp, E., Binnion, C., Turner, J., Milne, D., Butow, P., Lambert, S., Yates, P., Yip, D., & Koczwara, B. (in submission, Oct 2016). Uptake and adherence to an online intervention for cancer-related distress: older age is not a barrier to adherence but may be a barrier to uptake. Journal of Supportive Care in Cancer.
5. Beatty, L., Binnion, C., Kemp, E., & Koczwara, B., (in submission, Oct 2016). A qualitative exploration of barriers and facilitators to adherence to an online self-help intervention for cancer-related distress. Journal of Supportive Care in Cancer.
PRESENTATIONS
1. Beatty, L., Koczwara, B., & Wade, T. (2012, November). iCanCope: the internet Cancer Coping guide – a preliminary evaluation of an online self-directed intervention for reducing distress in early stage cancer patients. International Psycho-Oncology Society (IPOS) 14th World Congress. November 13-15, Brisbane, Australia.
2.	Binnion C., Beatty L., Kemp E., & Koczwara B. (2015, February). 'Finding My Way: An interim analysis of predictors of adherence to an internet self-help program for cancer-related distress. Flinders Centre for Innovation in Cancer 2015 Survivorship Conference, Adelaide, Australia.
3.	Beatty L., Kemp E., Wade T., Katris P., Wootten A., Yip D., Lambert S., Turner J., Yates P., Butow P., & Koczwara B.  (2014, November). Finding My Way: preliminary findings from a RCT evaluating an internet self-help program for cancer-related distress. Clinical Oncology Society of Australia, 41st Annual Scientific Meeting, Melbourne, Australia
4.	Beatty, L. (2016). Symposium Chair and presenter. Symposium: Online psychological interventions for cancer-related distress.  Presentation: who uses, and how do they benefit from, online psychotherapuetic interventions for cancer-related distress? An outcomes analysis of Finding My Way. International Congress of Behavioral Medicine. December 7-10, Melbourne, Australia.
5.	INVITED SPEAKER: Beatty L. (2016). Finding My Way: A Web-Based Psychosocial Intervention For Cancer Related Distress - An Outcomes Analysis Of A Multicentre RCT. Clinical Oncology Society of Australia’s 43rd Annual Scientific Meeting. November 15-17, Gold Coast, Australia.
6.	INVITED SPEAKER:  Beatty L. (2016). Online self-directed psychosocial interventions for cancer-related distress.  Multinational Assocation for Supportive Care in Cancer Annual Scientific Meeting. June 23-25, Adelaide, Australia.

Public notes

Contacts

Principal investigator

Name

Dr Lisa Beatty

Address

School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61882012506

Fax

+61882013877

Email

lisa.beatty@flinders.edu.au

Contact person for public queries

Name

Lisa Beatty

Address

School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61882012506

Fax

+61882013877

Email

lisa.beatty@flinders.edu.au

Contact person for scientific queries

Name

Lisa Beatty

Address

School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61882012506

Fax

+61882013877

Email

lisa.beatty@flinders.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

Source	Title	Year of Publication	DOI
Embase	Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.	2019	https://dx.doi.org/10.1007/s00520-018-4526-1
Embase	Moderators of intervention efficacy for Finding My Way: A web-based psychosocial intervention for cancer-related distress.	2021	https://dx.doi.org/10.1007/s00520-021-06291-w

N.B. These documents automatically identified may not have been verified by the study sponsor.